vancomycin: list of nationally authorised medicinal products - … · edicin 0,5 g prašak za...

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Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 15 October 2020 EMA/647607/2020 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: vancomycin Procedure no.: PSUSA/00003097/202001

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Page 1: vancomycin: List of nationally authorised medicinal products - … · Edicin 0,5 g prašak za otopinu za infuziju not available UP/I-530-09/13-02/237 SANDOZ D.O.O. HR EDICIN 0,5 g

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

15 October 2020 EMA/647607/2020 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: vancomycin

Procedure no.: PSUSA/00003097/202001

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List of nationally authorised medicinal products EMA/647607/2020 Page 2/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Bactocin, pulver til infusionsvæske, opløsning FI/H/0882/002 46553 MIP PHARMA GMBH DK

Bactocin, pulver til infusionsvæske, opløsning FI/H/0882/001 46552 MIP PHARMA GMBH DK

Edicin 0,5 g prašak za otopinu za infuziju not available UP/I-530-09/13-02/237 SANDOZ D.O.O. HR

EDICIN 0,5 g prášek pro koncentrát pro infuzní roztok not available 15/165/97-C

LEK PHARMACEUTICALS D.D. LJUBLJANA CZ

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List of nationally authorised medicinal products EMA/647607/2020 Page 3/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

EDICIN 0,5 g prášok na infúzny roztok NL/H/4445/001 15/0869/09-S

SANDOZ PHARMACEUTICALS D.D. SK

Edicin 1 g prašak za otopinu za infuziju not available UP/I-530-09/13-02/238 SANDOZ D.O.O. HR

EDICIN 1 g prášek pro koncentrát pro infuzní roztok not available 15/164/97-C

LEK PHARMACEUTICALS D.D. LJUBLJANA CZ

EDICIN 1 g prášok na infúzny roztok NL/H/4445/002 15/0870/09-S

SANDOZ PHARMACEUTICALS D.D. SK

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List of nationally authorised medicinal products EMA/647607/2020 Page 4/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Edicin 1000 mg prašek za koncentrat za raztopino za infundiranje not available H/93/00525/002

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Edicin 500 mg prašek za koncentrat za raztopino za infundiranje not available H/93/00525/001

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

EDICIN, 1 G, PROSZEK DO SPORZĄDZANIA ROZTWORU DO INFUZJI not available R/7011 SANDOZ GMBH PL

EDICIN, 500 MG, PROSZEK DO SPORZĄDZANIA ROZTWORU DO INFUZJI not available R/7010 SANDOZ GMBH PL

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List of nationally authorised medicinal products EMA/647607/2020 Page 5/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

LEVOVANOX 1 g polvere per soluzione per infusione endovenosa e per soluzione orale not available 035003021 GENETIC SPA IT

LEVOVANOX 250 mg Capsule rigide not available 035003033 GENETIC SPA IT

LEVOVANOX 500 mg polvere per soluzione per infusione endovenosa e per soluzione orale not available 035003019 GENETIC SPA IT

MAXIVANIL 1 g polvere per soluzione per infusione endovenosa e per soluzione orale not available 034984029 GENETIC SPA IT

MAXIVANIL 250 mg Capsule rigide not available 034984031 GENETIC SPA IT

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List of nationally authorised medicinal products EMA/647607/2020 Page 6/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

MAXIVANIL 500 mg polvere per soluzione per infusione endovenosa e per soluzione orale not available 034984017 GENETIC SPA IT

Selamat 1000 mg por oldatos infúzióhoz való koncentrátumhoz HU/H/0542/002 OGYI-T-22781/02 ACTAVIS GROUP PTC EHF. HU

Selamat 500 mg por oldatos infúzióhoz való koncentrátumhoz HU/H/0542/001 OGYI-T-22781/01 ACTAVIS GROUP PTC EHF. HU

Vamysin 1000 mg poeder voor concentraat voor oplossing voor infusie. DE/H/5737/002 BE405291

TEVA PHARMA BELGIUM N.V./S.A BE

Vamysin 1000 mg, poudre pour solution à diluer pour solution pour perfusion DE/H/5737/002 2014090289

TEVA PHARMA BELGIUM N.V./S.A LU

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List of nationally authorised medicinal products EMA/647607/2020 Page 7/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vamysin 500 mg poeder voor concentraat voor oplossing voor infusie. DE/H/5737/001 BE405282

TEVA PHARMA BELGIUM N.V./S.A BE

Vamysin 500 mg, poudre pour solution à diluer pour solution pour perfusion DE/H/5737/001 2014090288

TEVA PHARMA BELGIUM N.V./S.A LU

Vanco Sapiens 1g Σκόνη για διάλυμα προς έγχυση not available 22213

SAPIENS PHARMACEUTICALS LTD CY

Vanco Sapiens 1g Σκόνη για διάλυμα προς έγχυση not available 22213

SAPIENS PHARMACEUTICALS LTD CY

Vanco Sapiens 1g Σκόνη για διάλυμα προς έγχυση not available 22213

SAPIENS PHARMACEUTICALS LTD CY

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List of nationally authorised medicinal products EMA/647607/2020 Page 8/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vanco Sapiens 500mg κόνις για διάλυμα προς έγχυση not available 022837

SAPIENS PHARMACEUTICALS LTD CY

Vanco Sapiens 500mg κόνις για διάλυμα προς έγχυση not available 022837

SAPIENS PHARMACEUTICALS LTD CY

Vanco Sapiens 500mg κόνις για διάλυμα προς έγχυση not available 022837

SAPIENS PHARMACEUTICALS LTD CY

Vancocaps 250 mg harde capsules NL/H/3359/001 RVG116655

EUROCEPT INTERNATIONAL BV NL

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List of nationally authorised medicinal products EMA/647607/2020 Page 9/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancocaps 250 mg, capsules, hard NL/H/3359/001 BE503253

EUROCEPT INTERNATIONAL BV BE

Vancocaps 250 mg, gélules NL/H/3359/001 BE503253

EUROCEPT INTERNATIONAL BV BE

Vancocaps 250 mg, gélules NL/H/3359/001 2017040148 EUROCEPT B.V. LU

Vancocaps 250 mg, Hartkapseln NL/H/3359/001 BE503253

EUROCEPT INTERNATIONAL BV BE

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List of nationally authorised medicinal products EMA/647607/2020 Page 10/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancocaps 250 mg, Hartkapseln NL/H/3359/001 2017040148 EUROCEPT B.V. LU

Vancocin 1 g Pulver für ein Konzentrat zur Herstellung einer Infusionslösung und einer Lösung zum Einnehmen not available 1-19487 ASTRO-PHARMA GMBH AT

Vancocin 1 g powder for concentrate for solution for infusion and powder for oral solution. not available PA1226/005/004 FLYNN PHARMA LTD IE

Vancocin 1000 mg powder for solution for infusion and oral solution. not available PL 13621/0033 FLYNN PHARMA LTD UK

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List of nationally authorised medicinal products EMA/647607/2020 Page 11/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancocin 125 mg kapsel, hård not available 10514 STADA NORDIC APS SE

Vancocin 500 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung und einer Lösung zum Einnehmen not available 17.126 ASTRO-PHARMA GMBH AT

Vancocin 500 mg powder for concentrate for solution for infusion and powder for oral solution. not available PA1226/005/003 FLYNN PHARMA LTD IE

Vancocin 500 mg powder for solution for infusion and oral solution. not available PL 13621/0033 FLYNN PHARMA LTD UK

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List of nationally authorised medicinal products EMA/647607/2020 Page 12/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancocin CP 250 mg, capsules not available RVG 11984

EUROCEPT INTERNATIONAL BV NL

Vancocin Matrigel 125mg Hard Capsules not available PA 1226/005/001 FLYNN PHARMA LTD IE

Vancocin Matrigel 125mg Hard capsules not available PL 13621/0030 FLYNN PHARMA LTD UK

Vancocin, kapsler, hårde not available 30087 STRIDES PHARMA (CYPRUS) LIMITED DK

Vancocin, kapsler, hårde not available 12076 STRIDES PHARMA (CYPRUS) LIMITED DK

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List of nationally authorised medicinal products EMA/647607/2020 Page 13/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOCINA A.P. 500 mg polvere per concentrato per soluzione per infusione e per soluzione orale not available 016334029 VANCOCIN ITALIA S.R.L IT

VANCOCINA A.P. 500 mg polvere per concentrato per soluzione per infusione e per soluzione orale not available 016334029 VANCOCIN ITALIA S.R.L IT

VANCOMICINA ACCORD 1 g IV EFG not available 62292 ACCORD HEALTHCARE S.L.U. ES

VANCOMICINA ACCORD 500 mg IV EFG not available 62293 ACCORD HEALTHCARE S.L.U. ES

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List of nationally authorised medicinal products EMA/647607/2020 Page 14/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Azevedos, 1000 mg, Pó para solução para perfusão not available 5623723

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Azevedos, 1000 mg, Pó para solução para perfusão not available 5623731

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Azevedos, 1000 mg, Pó para solução para perfusão not available 5623749

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Azevedos, 1000 mg, Pó para solução para perfusão not available 5623756

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Azevedos, 500 mg, Pó para solução para perfusão not available 5623665

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

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List of nationally authorised medicinal products EMA/647607/2020 Page 15/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Azevedos, 500 mg, Pó para solução para perfusão not available 5623673

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Azevedos, 500 mg, Pó para solução para perfusão not available 5623707

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Azevedos, 500 mg, Pó para solução para perfusão not available 5623715

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

VANCOMICINA COMBINO 1000 mg, pó para solução para perfusão not available 5214465

ACCORD HEALTHCARE LIMITED PT

VANCOMICINA COMBINO 500 mg, pó para solução para perfusão not available 5214457

ACCORD HEALTHCARE LIMITED PT

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List of nationally authorised medicinal products EMA/647607/2020 Page 16/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Generis 1000 mg pó para concentrado para solução para perfusão not available 2679280

GENERIS FARMACÊUTICA, S.A. PT

Vancomicina Generis 1000 mg pó para concentrado para solução para perfusão not available 2679389

GENERIS FARMACÊUTICA, S.A. PT

Vancomicina Generis 500 mg pó para concentrado para solução para perfusão not available 2679082

GENERIS FARMACÊUTICA, S.A. PT

Vancomicina Generis 500 mg pó para concentrado para solução para perfusão not available 2679181

GENERIS FARMACÊUTICA, S.A. PT

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List of nationally authorised medicinal products EMA/647607/2020 Page 17/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOMICINA HIKMA 1000 mg polvere per concentrato per soluzione per infusione e per soluzione orale not available 035004050 HIKMA ITALIA S.P.A. IT

VANCOMICINA HIKMA 1000 mg polvere per concentrato per soluzione per infusione e per soluzione orale not available 035004023 HIKMA ITALIA S.P.A. IT

VANCOMICINA HIKMA 500 mg polvere per concentrato per soluzione per infusione e per soluzione orale not available 035004047 HIKMA ITALIA S.P.A. IT

VANCOMICINA HIKMA 500 mg polvere per concentrato per soluzione per infusione e per soluzione orale not available 035004011 HIKMA ITALIA S.P.A. IT

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List of nationally authorised medicinal products EMA/647607/2020 Page 18/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Hikma, 1000 mg, pó para concentrado para solução para perfusão PT/H/0771/002 5570429

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Vancomicina Hikma, 1000 mg, pó para concentrado para solução para perfusão PT/H/0771/002 5570437

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Vancomicina Hikma, 1000 mg, Pó para solução para perfusão PT/H/0339/002 5182951

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Vancomicina Hikma, 1000 mg, Pó para solução para perfusão PT/H/0339/002 5182944

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Vancomicina Hikma, 500 mg, pó para concentrado para solução para perfusão PT/H/0771/001 5569876

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

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List of nationally authorised medicinal products EMA/647607/2020 Page 19/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Hikma, 500 mg, pó para concentrado para solução para perfusão PT/H/0771/001 5569900

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Vancomicina Hikma, 500 mg, Pó para solução para perfusão PT/H/0339/001 5182928

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Vancomicina Hikma, 500 mg, Pó para solução para perfusão PT/H/0339/001 5182936

HIKMA FARMACÊUTICA (PORTUGAL), S.A. PT

Vancomicina Kabi 1000 mg pó para concentrado para solução para perfusão. PT/H/2179/002 5571849

FRESENIUS KABI PHARMA PORTUGAL, LDA. PT

Vancomicina Kabi 1000 mg pó para concentrado para solução para perfusão. PT/H/2179/002 5379854

FRESENIUS KABI PHARMA PORTUGAL, LDA. PT

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List of nationally authorised medicinal products EMA/647607/2020 Page 20/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Kabi 1000 mg pulbere pentru concentrat pentru soluţie perfuzabilă PT/H/2179/002 8513/2016/01

FRESENIUS KABI ROMANIA SRL RO

Vancomicina Kabi 1000 mg pulbere pentru concentrat pentru soluţie perfuzabilă PT/H/2179/002 8513/2016/02

FRESENIUS KABI ROMANIA SRL RO

Vancomicina Kabi 500 mg pó para concentrado para solução para perfusão. PT/H/2179/001 5571831

FRESENIUS KABI PHARMA PORTUGAL, LDA. PT

Vancomicina Kabi 500 mg pó para concentrado para solução para perfusão. PT/H/2179/001 5378039

FRESENIUS KABI PHARMA PORTUGAL, LDA. PT

Vancomicina Kabi 500 mg pulbere pentru concentrat pentru soluţie perfuzabilă PT/H/2179/001 8512/2016/01

FRESENIUS KABI ROMANIA SRL RO

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List of nationally authorised medicinal products EMA/647607/2020 Page 21/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Kabi 500 mg pulbere pentru concentrat pentru soluţie perfuzabilă PT/H/2179/001 8512/2016/02

FRESENIUS KABI ROMANIA SRL RO

Vancomicina Labesfal 1000 mg Pó para concentrado para solução para perfusão. not available 3211398

LABESFAL LABORATORIOS ALMIRO, S.A. PT

Vancomicina Labesfal 1000 mg Pó para concentrado para solução para perfusão. not available 3211497

LABESFAL LABORATORIOS ALMIRO, S.A. PT

Vancomicina Labesfal 1000 mg Pó para concentrado para solução para perfusão. not available 5164033

LABESFAL LABORATORIOS ALMIRO, S.A. PT

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List of nationally authorised medicinal products EMA/647607/2020 Page 22/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Labesfal 500 mg Pó para concentrado para solução para perfusão. not available 3211190

LABESFAL LABORATORIOS ALMIRO, S.A. PT

Vancomicina Labesfal 500 mg Pó para concentrado para solução para perfusão. not available 3211299

LABESFAL LABORATORIOS ALMIRO, S.A. PT

Vancomicina Labesfal 500 mg Pó para concentrado para solução para perfusão. not available 5164025

LABESFAL LABORATORIOS ALMIRO, S.A. PT

Vancomicina MIP 1000 mg polvo para solución para perfusión EFG FI/H/0889/002 78671 MIP PHARMA GMBH ES

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List of nationally authorised medicinal products EMA/647607/2020 Page 23/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina MIP 500 mg polvo para solución para perfusión EFG FI/H/0889/001 78672 MIP PHARMA GMBH ES

Vancomicina Mylan 1 g polvere per soluzione per infusione CZ/H/0351/002 041220082/M MYLAN S.P.A. IT

Vancomicina Mylan 1 g polvere per soluzione per infusione CZ/H/0351/002 041220070/M MYLAN S.P.A. IT

Vancomicina Mylan 1 g polvere per soluzione per infusione CZ/H/0351/002 041220068/M MYLAN S.P.A. IT

Vancomicina Mylan 1 g polvere per soluzione per infusione CZ/H/0351/002 41220056/M MYLAN S.P.A. IT

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List of nationally authorised medicinal products EMA/647607/2020 Page 24/123

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Mylan 1000 mg pó para concentrado para solução para perfusão. SE/H/1158/002 5648928 MYLAN, LDA PT

Vancomicina Mylan 1000 mg pó para concentrado para solução para perfusão. SE/H/1158/002 5648944 MYLAN, LDA PT

Vancomicina Mylan 1000 mg pulbere pentru concentrat pentru soluţie perfuzabilă SE/H/1158/002 9921/2017/01 MYLAN S.A.S RO

Vancomicina Mylan 500 mg pó para concentrado para solução para perfusão. SE/H/1158/001 5648910 MYLAN, LDA PT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Mylan 500 mg polvere per soluzione per infusione CZ/H/0351/001 041220017/M MYLAN S.P.A. IT

Vancomicina Mylan 500 mg polvere per soluzione per infusione CZ/H/0351/001 041220029/M MYLAN S.P.A. IT

Vancomicina Mylan 500 mg polvere per soluzione per infusione CZ/H/0351/001 041220031/M MYLAN S.P.A. IT

Vancomicina Mylan 500 mg polvere per soluzione per infusione CZ/H/0351/001 041220043 MYLAN S.P.A. IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Mylan 500 mg pulbere pentru concentrat pentru soluţie perfuzabilă SE/H/1158/001 9920/2017/01 MYLAN S.A.S RO

Vancomicina Pfizer 1.000 mg polvo para concentrado para solución para perfusión EFG. AT/H/0876/002 73785 PFIZER, S.L. ES

Vancomicina Pfizer 500 mg polvo para concentrado para solución para perfusión EFG AT/H/0876/001 73784 PFIZER, S.L. ES

Vancomicina Quimedical, 1000 mg, Pó para concentrado para solução para perfusão PT/H/1401/002 5623624

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Quimedical, 1000 mg, Pó para concentrado para solução para perfusão PT/H/1401/002 5623632

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Quimedical, 1000 mg, Pó para concentrado para solução para perfusão PT/H/1401/002 5623640

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Quimedical, 1000 mg, Pó para concentrado para solução para perfusão PT/H/1401/002 5623657

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Quimedical, 500 mg, Pó para concentrado para solução para perfusão PT/H/1401/001 5623368

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Quimedical, 500 mg, Pó para concentrado para solução para perfusão PT/H/1401/001 5623376

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomicina Quimedical, 500 mg, Pó para concentrado para solução para perfusão PT/H/1401/001 5623400

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

Vancomicina Quimedical, 500 mg, Pó para concentrado para solução para perfusão PT/H/1401/001 5623418

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT

VANCOMICINA SALA 1 g, Polvo para solución inyectable EFG not available 67.283

LABORATORIO REIG JOFRE, S.A. ES

VANCOMICINA SALA 500 mg, Polvo para solución inyectable not available 67.282

LABORATORIO REIG JOFRE, S.A. ES

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomimylan 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung SE/H/1158/002 BE434147 MYLAN BVBA/SPRL BE

Vancomimylan 1000 mg, poeder voor concentraat voor oplossing voor infusie SE/H/1158/002 BE434147 MYLAN BVBA/SPRL BE

Vancomimylan 1000 mg, poudre pour solution à diluer pour solution pour perfusion SE/H/1158/002 BE434147 MYLAN BVBA/SPRL BE

Vancomimylan 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung SE/H/1158/001 BE434131 MYLAN BVBA/SPRL BE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomimylan 500 mg, poeder voor concentraat voor oplossing voor infusie SE/H/1158/001 BE434131 MYLAN BVBA/SPRL BE

Vancomimylan 500 mg, poudre pour solution à diluer pour solution pour perfusion SE/H/1158/001 BE434131 MYLAN BVBA/SPRL BE

Vancomycin CP 1,0 g Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.03.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin CP 500 mg Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.02.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

Vancomycin "Lederle" 1000 mg; Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen not available 36654.01.00 RIEMSER PHARMA GMBH DE

Vancomycin "Lederle" 500 mg; Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen not available 36654.00.00 RIEMSER PHARMA GMBH DE

Vancomycin "Reig Jofre", pulver til koncentrat til infusionsvæske, opløsning not available 53803

LABORATORIO REIG JOFRE, S.A. DK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin "Reig Jofre", pulver til koncentrat til infusionsvæske, opløsning not available 53804

LABORATORIO REIG JOFRE, S.A. DK

Vancomycin "Sandoz" NL/H/4445/001 42478 SANDOZ A/S DK

Vancomycin "Sandoz" NL/H/4445/002 42479 SANDOZ A/S DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/002 57500

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

Vancomycin "Strides", hårde kapsler DK/H/2629/001 57499

STRIDES PHARMA (CYPRUS) LIMITED DK

VANCOMYCIN / ΦΟΙΝΙΞΦΑΡΜ (Βανκομυκίνη CP, χρωματογραφικά κεκαθαρμένη βανκομυκίνη) not available 18136/21-12-2011 FINIXFARM LTD GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin ”Fresenius Kabi”, pulver til koncentrat til infusionsvæske, opløsning PT/H/2179/001 45259 FRESENIUS KABI AB DK

Vancomycin ”Fresenius Kabi”, pulver til koncentrat til infusionsvæske, opløsning PT/H/2179/002 45260 FRESENIUS KABI AB DK

Vancomycin ”Mylan”, pulver til koncentrat til infusionsvæske, opløsning SE/H/1158/001 50506 MYLAN IRELAND LIMITED DK

Vancomycin ”Mylan”, pulver til koncentrat til infusionsvæske, opløsning SE/H/1158/002 50507 MYLAN IRELAND LIMITED DK

Vancomycin ”Orion”, pulver til koncentrat til infusionsvæske, opløsning FI/H/0845/001 53549 ORION CORPORATION DK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin ”Orion”, pulver til koncentrat til infusionsvæske, opløsning FI/H/0845/002 53550 ORION CORPORATION DK

Vancomycin 1000 mg powder for concentrate for solution for infusion PT/H/1401/002 PA 1852/004/002

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. IE

Vancomycin 1000 mg Powder for concentrate for solution for infusion PT/H/0771/002 PA1217/009/002

HIKMA FARMACÊUTICA (PORTUGAL), S.A. IE

Vancomycin 1000 mg Powder for concentrate for solution for infusion PT/H/0771/002 PA1217/009/002

HIKMA FARMACÊUTICA (PORTUGAL), S.A. IE

Vancomycin 1000 mg Powder for concentrate for solution for infusion PT/H/2179/002 PA 2059/066/002

FRESENIUS KABI DEUTSCHLAND GMBH IE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin 1000 mg Powder for concentrate for solution for infusion and oral solution IE/H/0706/002 PA1122/008/002 NORIDEM ENTERPRISES LTD IE

Vancomycin 1000 mg Powder for concentrate for solution for infusion and oral solution IE/H/0706/002 PL 24598/0016 NORIDEM ENTERPRISES LTD UK

Vancomycin 1000 mg Powder for concentrate for solution for infusion. PT/H/2179/002 PL 08828/0238 FRESENIUS KABI LIMITED UK

Vancomycin 1000 mg powder for concentrate for solution for infusion. AT/H/0876/002 PL 00057/1169 PFIZER LIMITED UK

Vancomycin 1000 mg, Powder for concentrate for solution for infusion PT/H/1401/002 PL 24065/0006 - 0001

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. UK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin 1000 mg, powder for concentrate for solution for infusion SE/H/1158/002 PL 04569/1603 GENERICS [UK] LIMITED UK

Vancomycin 1000 mg, Powder for solution for infusion FI/H/0889/002 PL 26928/0016 MIP PHARMA GMBH UK

Vancomycin 1000, 1000 mg Pulver zur Herstellung einer Infusionslösung DE/H/0368/002 39981.01.00 MIP PHARMA GMBH DE

Vancomycin 125 mg hard capsules UK/H/5577/001 PL 13606/0196

STRIDES PHARMA UK LIMITED UK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin 125 mg hard capsules UK/H/5577/001 PL 13606/0196

STRIDES PHARMA UK LIMITED UK

Vancomycin 125mg Capsules, Hard. UK/H/2508/001 PL 20117/0149

MORNINGSIDE HEALTHCARE LTD UK

Vancomycin 1g Powder for Solution for Infusion not available 29831/0322 WOCKHARDT UK LTD UK

Vancomycin 1g Powder for Solution for Infusion not available 29831/0322 WOCKHARDT UK LTD UK

Vancomycin 1g Powder for Solution for Infusion not available PL 44095/0023 REIG JOFRE UK LIMITED UK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin 250 mg hard capsules UK/H/5577/002 PL 13606/0197

STRIDES PHARMA UK LIMITED UK

Vancomycin 250 mg hard capsules UK/H/5577/002 PL 13606/0197

STRIDES PHARMA UK LIMITED UK

Vancomycin 500 mg powder for concentrate for solution for infusion PT/H/1401/001 PA 1852/004/001

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. IE

Vancomycin 500 mg Powder for concentrate for solution for infusion PT/H/0771/001 PA1217/009/001

HIKMA FARMACÊUTICA (PORTUGAL), S.A. IE

Vancomycin 500 mg Powder for concentrate for solution for infusion PT/H/0771/001 PA1217/009/001

HIKMA FARMACÊUTICA (PORTUGAL), S.A. IE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin 500 mg Powder for concentrate for solution for infusion and oral solution IE/H/0706/001 PA 1122/008/001 NORIDEM ENTERPRISES LTD IE

Vancomycin 500 mg Powder for concentrate for solution for infusion and oral solution IE/H/0706/001 PL 24598/0015 NORIDEM ENTERPRISES LTD UK

Vancomycin 500 mg Powder for concentrate for solution for infusion. PT/H/2179/001 PA 2059/066/001

FRESENIUS KABI DEUTSCHLAND GMBH IE

Vancomycin 500 mg Powder for concentrate for solution for infusion. PT/H/2179/001 PL 08828/0237 FRESENIUS KABI LIMITED UK

Vancomycin 500 mg powder for concentrate for solution for infusion. AT/H/0876/001 PL 00057/1168 PFIZER LIMITED UK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin 500 mg, Powder for concentrate for solution for infusion PT/H/1401/001 PL 24065/0005 - 0001

LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. UK

Vancomycin 500 mg, powder for concentrate for solution for infusion SE/H/1158/001 PL 04569/1602 GENERICS [UK] LIMITED UK

Vancomycin 500 mg, Powder for solution for infusion FI/H/0889/001 PL 26928/0015 MIP PHARMA GMBH UK

Vancomycin 500, 500 mg Pulver zur Herstellung einer Infusionslösung DE/H/0368/001 42565.00.00 MIP PHARMA GMBH DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin 500mg Powder for Solution for Infusion not available PL 44095/0022 REIG JOFRE UK LIMITED UK

Vancomycin 500mg Powder for Solution for Infusion UK/H/7133/001/MR 29831/0319 WOCKHARDT UK LTD UK

Vancomycin 500mg Powder for Solution for Infusion UK/H/7133/001/MR 29831/0319 WOCKHARDT UK LTD UK

Vancomycin AB 1000 mg poeder voor concentraat voor oplossing voor infusie NL/H/4181/002 BE469120 AUROBINDO PHARMA B.V. BE

Vancomycin AB 1000 mg poudre pour solution à diluer pour perfusion NL/H/4181/002 BE469120 AUROBINDO PHARMA B.V. BE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin AB 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung NL/H/4181/002 BE469120 AUROBINDO PHARMA B.V. BE

Vancomycin AB 500 mg poeder voor concentraat voor oplossing voor infusie NL/H/4181/001 BE469111 AUROBINDO PHARMA B.V. BE

Vancomycin AB 500 mg poudre pour solution à diluer pour perfusion NL/H/4181/001 BE469111 AUROBINDO PHARMA B.V. BE

Vancomycin AB 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung NL/H/4181/001 BE469111 AUROBINDO PHARMA B.V. BE

Vancomycin Actavis 1.000 mg stofn fyrir innrennslisþykkni, lausn SE/H/1733/002 IS/1/15/019/02 ACTAVIS GROUP PTC EHF. IS

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Actavis 1000 mg pulver till koncentrat till infusionsvätska, lösning SE/H/1733/002 49322 ACTAVIS GROUP PTC EHF. SE

Vancomycin Actavis 500 mg pulver till koncentrat till infusionsvätska, lösning SE/H/1733/001 49321 ACTAVIS GROUP PTC EHF. SE

Vancomycin Actavis 500 mg stofn fyrir innrennslisþykkni, lausn SE/H/1733/001 IS/1/15/019/01 ACTAVIS GROUP PTC EHF. IS

Vancomycin Capsules 125 mg not available PL 17815/0041

XELLIA PHARMACEUTICALS APS UK

Vancomycin Capsules 250mg not available PL 17815/0042

XELLIA PHARMACEUTICALS APS UK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin CP 1,0 g Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.03.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

Vancomycin CP 1,0 g Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.03.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

Vancomycin CP 1,0 g Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.03.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin CP 500 mg Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.02.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

Vancomycin CP 500 mg Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.02.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

Vancomycin CP 500 mg Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Wirkstoff: Vancomycinhydrochlorid not available 16803.02.00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Dr. Eberth 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen AT/H/0569/002 92809.00.00

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH DE

Vancomycin Dr. Eberth 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder zur Herstellung einer Lösung zum Einnehmen AT/H/0569/002 137151

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH AT

Vancomycin Dr. Eberth 125 mg Hartkapseln DK/H/2629/001 138014

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH AT

Vancomycin Dr. Eberth 125 mg Hartkapseln DK/H/2629/001 138014

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH AT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Dr. Eberth 125 mg Hartkapseln DE/H/5908/001 90867.00.00

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH DE

Vancomycin Dr. Eberth 250 mg Hartkapseln DK/H/2629/002 138015

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH AT

Vancomycin Dr. Eberth 250 mg Hartkapseln DK/H/2629/002 138015

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH AT

Vancomycin Dr. Eberth 250 mg Hartkapseln DE/H/5908/002 90868.00.00

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Dr. Eberth 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen AT/H/0569/001 92808.00.00

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH DE

Vancomycin Dr. Eberth 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder zur Herstellung einer Lösung zum Einnehmen AT/H/0569/001 137150

DR. FRIEDRICH EBERTH ARZNEIMITTEL GMBH AT

Vancomycin ENTEROCAPS 125 mg Hartkapseln not available 95248.00.00 RIEMSER PHARMA GMBH DE

VANCOMYCIN ENTEROCAPS® 250 mg Kapseln not available 1-19057 RIEMSER PHARMA GMBH AT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin ENTEROCAPS® 250 mg, Hartkapseln not available 7422.01.00 RIEMSER PHARMA GMBH DE

Vancomycin FarmaPlus 1000 mg prášok na infúzny koncentrát SE/H/1158/002 15/0177/14-S MYLAN S.A.S SK

Vancomycin Fresenius Kabi 1 g pulver til konsentrat til infusjonsvæske, oppløsning. PT/H/2179/002 09-6842 FRESENIUS KABI NORGE AS NO

Vancomycin Fresenius Kabi 1.000 mg stofn fyrir innrennslisþykkni, lausn. PT/H/2179/002 IS/1/11/015/02 FRESENIUS KABI AB IS

Vancomycin Fresenius Kabi 500 mg pulver til konsentrat til infusjonsvæske, oppløsning. PT/H/2179/001 09-6841 FRESENIUS KABI NORGE AS NO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Fresenius Kabi 500 mg stofn fyrir innrennslisþykkni, lausn. PT/H/2179/001 IS/1/11/015/01 FRESENIUS KABI AB IS

Vancomycin Hikma 1000 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung PT/H/0771/002 1-31670

HIKMA FARMACÊUTICA (PORTUGAL), S.A. AT

Vancomycin Hikma 1000 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung PT/H/0771/002 1-31670

HIKMA FARMACÊUTICA (PORTUGAL), S.A. AT

Vancomycin Hikma 1000 mg por oldatos infúzióhoz PT/H/0339/002 OGYI-T-21716/03

HIKMA FARMACÊUTICA (PORTUGAL), S.A. HU

Vancomycin Hikma 1000 mg por oldatos infúzióhoz PT/H/0339/002 OGYI-T-21716/04

HIKMA FARMACÊUTICA (PORTUGAL), S.A. HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Hikma 500 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung PT/H/0771/001 1-31669

HIKMA FARMACÊUTICA (PORTUGAL), S.A. AT

Vancomycin Hikma 500 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung PT/H/0771/001 1-31669

HIKMA FARMACÊUTICA (PORTUGAL), S.A. AT

Vancomycin Hikma 500 mg por oldatos infúzióhoz PT/H/0339/001 OGYI-T-21716/01

HIKMA FARMACÊUTICA (PORTUGAL), S.A. HU

Vancomycin Hikma 500 mg por oldatos infúzióhoz PT/H/0339/001 OGYI-T-21716/02

HIKMA FARMACÊUTICA (PORTUGAL), S.A. HU

Vancomycin Hydrochloride 1 g Powder for Concentrate for Infusion not available PL 04515/0053 HOSPIRA UK LTD UK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Hydrochloride 500 mg Powder for Concentrate for Infusion not available PL 04515/0053 HOSPIRA UK LTD UK

Vancomycin Kabi 1 000 mg prášok na infúzny koncentrát PT/H/2179/002 15/0325/11-S FRESENIUS KABI S.R.O. SK

Vancomycin Kabi 1 g Pulver für ein Konzentrat zur Herstellung einer Infusionslösung PT/H/2179/002 78732.00.00

FRESENIUS KABI DEUTSCHLAND GMBH DE

Vancomycin Kabi 1 g Pulver zur Herstellung eines Konzentrats für eine Infusionslösung PT/H/2179/002 2012100184

FRESENIUS KABI DEUTSCHLAND GMBH LU

Vancomycin Kabi 1000 mg milteliai infuzinio tirpalo koncentratui PT/H/2179/002 LT/1/11/2505/004

FRESENIUS KABI POLSKA SP. Z O.O. LT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Kabi 1000 mg milteliai infuzinio tirpalo koncentratui PT/H/2179/002 LT/1/11/2505/002

FRESENIUS KABI POLSKA SP. Z O.O. LT

Vancomycin Kabi 1000 mg por oldatos infúzióhoz való koncentrátumhoz PT/H/2179/002 OGYI-T-21953/04

FRESENIUS KABI HUNGARY KFT. HU

Vancomycin Kabi 1000 mg por oldatos infúzióhoz való koncentrátumhoz PT/H/2179/002 OGYI-T-21953/02

FRESENIUS KABI HUNGARY KFT. HU

Vancomycin Kabi 1000 mg prášek pro koncentrát pro infuzní roztok PT/H/2179/002 15/374/11-C FRESENIUS KABI S.R.O. CZ

Vancomycin Kabi 1000 mg pulveris infūziju šķīduma koncentrāta pagatavošanai. PT/H/2179/002 11-0221

FRESENIUS KABI POLSKA SP. Z O.O. LV

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Kabi 1000 mg, infusioonilahuse kontsentraadi pulber PT/H/2179/002 733211

FRESENIUS KABI POLSKA SP. Z O.O. EE

Vancomycin Kabi 500 mg milteliai infuzinio tirpalo koncentratui PT/H/2179/001 LT/1/11/2505/003

FRESENIUS KABI POLSKA SP. Z O.O. LT

Vancomycin Kabi 500 mg milteliai infuzinio tirpalo koncentratui PT/H/2179/001 LT/1/11/2505/001

FRESENIUS KABI POLSKA SP. Z O.O. LT

Vancomycin Kabi 500 mg por oldatos infúzióhoz való koncentrátumhoz PT/H/2179/001 OGYI-T-21953/03

FRESENIUS KABI HUNGARY KFT. HU

Vancomycin Kabi 500 mg por oldatos infúzióhoz való koncentrátumhoz PT/H/2179/001 OGYI-T-21953/01,03

FRESENIUS KABI HUNGARY KFT. HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Kabi 500 mg prášek pro koncentrát pro infuzní roztok PT/H/2179/001 15/373/111-C FRESENIUS KABI S.R.O. CZ

Vancomycin Kabi 500 mg prášok na infúzny koncentrát PT/H/2179/001 15/0324/11-S FRESENIUS KABI S.R.O. SK

Vancomycin Kabi 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung PT/H/2179/001 78731.00.00

FRESENIUS KABI DEUTSCHLAND GMBH DE

Vancomycin Kabi 500 mg Pulver zur Herstellung eines Konzentrats für eine Infusionslösung PT/H/2179/001 2012100183

FRESENIUS KABI DEUTSCHLAND GMBH LU

Vancomycin Kabi 500 mg pulveris infūziju šķīduma koncentrāta pagatavošanai. PT/H/2179/001 11-0222

FRESENIUS KABI POLSKA SP. Z O.O. LV

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Kabi 500 mg, infusioonilahuse kontsentraadi pulber PT/H/2179/001 733111

FRESENIUS KABI POLSKA SP. Z O.O. EE

Vancomycin Kabi, 1000 mg, proszek do sporządzania koncentratu roztworu do infuzji PT/H/2179/002 18691

FRESENIUS KABI POLSKA SP. Z O.O. PL

Vancomycin Kabi, 500 mg, proszek do sporządzania koncentratu roztworu do infuzji PT/H/2179/001 18690

FRESENIUS KABI POLSKA SP. Z O.O. PL

Vancomycin Lyomark 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen not available 99760.00.00 LYOMARK PHARMA GMBH DE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Lyomark 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnnehmen not available 6614009.00.00 LYOMARK PHARMA GMBH DE

Vancomycin MIP 1 000 mg prášok na infúzny roztok FI/H/0889/002 15/0265/15-S MIP PHARMA GMBH SK

Vancomycin MIP 1 000 mg pulver till infusionsvätska, lösning DE/H/0368/002 21112 MIP PHARMA GMBH SE

Vancomycin MIP 1000 mg por oldatos infúzióhoz FI/H/0889/002 OGYI-T-22761/03 MIP PHARMA GMBH HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin MIP 1000 mg por oldatos infúzióhoz FI/H/0889/002 OGYI-T-22761/04 MIP PHARMA GMBH HU

Vancomycin MIP 1000 mg pulver til infusjonsvæske, oppløsning DE/H/0368/002 04-2720 MIP PHARMA GMBH NO

Vancomycin MIP 500 mg por oldatos infúzióhoz FI/H/0889/001 OGYI-T-22761/01 MIP PHARMA GMBH HU

Vancomycin MIP 500 mg por oldatos infúzióhoz FI/H/0889/001 OGYI-T-22761/02 MIP PHARMA GMBH HU

Vancomycin MIP 500 mg prášok na infúzny roztok FI/H/0889/001 15/0264/15-S MIP PHARMA GMBH SK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin MIP 500 mg pulver til infusjonsvæske, oppløsning DE/H/0368/001 04-2718 MIP PHARMA GMBH NO

Vancomycin MIP 500 mg pulver till infusionsvätska, lösning DE/H/0368/001 21111 MIP PHARMA GMBH SE

Vancomycin MIP Pharma 1000 mg prášek pro infuzní roztok FI/H/0889/002 15/028/15-C MIP PHARMA GMBH CZ

Vancomycin MIP Pharma 1000 mg, Infuusiokuiva-aine, liuosta varten FI/H/0889/002 28524 MIP PHARMA GMBH FI

Vancomycin MIP Pharma 1000 mg, pulver till infusionsvätska, lösning FI/H/0889/002 28524 MIP PHARMA GMBH FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin MIP Pharma 500 mg prášek pro infuzní roztok FI/H/0889/001 15/027/15-C MIP PHARMA GMBH CZ

Vancomycin MIP Pharma 500 mg, Infuusiokuiva-aine, liuosta varten FI/H/0889/001 28523 MIP PHARMA GMBH FI

Vancomycin MIP Pharma 500 mg, pulver till infusionsvätska, lösning FI/H/0889/001 28523 MIP PHARMA GMBH FI

Vancomycin Mylan 1 000 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos SE/H/1158/002 30628 MYLAN IRELAND LIMITED FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Mylan 1 g prášok na infúzny roztok CZ/H/0351/002 15/0365/11-S MYLAN S.A.S SK

Vancomycin Mylan 1 g, powder for solution for infusion CZ/H/0351/002 PA0577/163/002

MCDERMOTT LABORATORIES LTD IE

Vancomycin Mylan 1000 mg milteliai infuzinio tirpalo koncentratui SE/H/1158/002 LT/1/13/3204/002 MYLAN S.A.S LT

Vancomycin Mylan 1000 mg prášek pro přípravu infuzního roztoku CZ/H/0351/002 15/355/11-C MYLAN S.A.S CZ

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Mylan 1000 mg pulver til konsentrat til infusjonsvæske, oppløsning SE/H/1158/002 12-8969 MYLAN IRELAND LIMITED NO

Vancomycin Mylan 1000 mg pulver till koncentrat till infusionsvätska, lösning SE/H/1158/002 47797 MYLAN IRELAND LIMITED SE

Vancomycin Mylan 1000 mg pulveris infūziju šķīduma koncentrāta pagatavošanai SE/H/1158/002 13-0041 MYLAN S.A.S LV

Vancomycin Mylan 1000 mg, pulver till koncentrat till infusionsvätska, lösning SE/H/1158/002 30628 MYLAN IRELAND LIMITED FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOMYCIN MYLAN 1000 mg, κόνις για διάλυμα προς έγχυση CZ/H/0351/002 21307 MYLAN S.A.S CY

Vancomycin Mylan 500 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos SE/H/1158/001 30627 MYLAN IRELAND LIMITED FI

Vancomycin Mylan 500 mg milteliai infuzinio tirpalo koncentratui SE/H/1158/001 LT/1/13/3204/001 MYLAN S.A.S LT

Vancomycin Mylan 500 mg prášek pro infuzní roztok CZ/H/0351/001 15/354/11-C MYLAN S.A.S CZ

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Mylan 500 mg prášok na infúzny roztok CZ/H/0351/001 15/0364/11-S MYLAN S.A.S SK

Vancomycin Mylan 500 mg pulver til konsentrat til infusjonsvæske, oppløsning SE/H/1158/001 12-8968 MYLAN IRELAND LIMITED NO

Vancomycin Mylan 500 mg pulver till koncentrat till infusionsvätska, lösning SE/H/1158/001 10413 MYLAN IRELAND LIMITED SE

Vancomycin Mylan 500 mg pulveris infūziju šķīduma koncentrāta pagatavošanai SE/H/1158/001 13-0042 MYLAN S.A.S LV

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Mylan 500 mg, powder for solution for infusion CZ/H/0351/001 PA0577/163/001

MCDERMOTT LABORATORIES LTD IE

Vancomycin Mylan 500 mg, pulver till koncentrat till infusionsvätska, lösning SE/H/1158/001 30627 MYLAN IRELAND LIMITED FI

VANCOMYCIN MYLAN 500 mg, κόνις για διάλυμα προς έγχυση CZ/H/0351/001 21307 MYLAN S.A.S CY

Vancomycin Noridem 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung und Lösung zum Einnehmen IE/H/0706/002 1-30790 NORIDEM ENTERPRISES LTD AT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Noridem 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung und Lösung zum Einnehmen IE/H/0706/002 73936.00.00 NORIDEM ENTERPRISES LTD DE

Vancomycin Noridem 500 mg Pulver fur ein Konzentrat zur Herstellung einer Infusionslosung und Losung zum Einnehmen IE/H/0706/001 73935.00.00 NORIDEM ENTERPRISES LTD DE

Vancomycin Noridem 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung und Lösung zum Einnehmen IE/H/0706/001 1-30789 NORIDEM ENTERPRISES LTD AT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Olikla 1000 mg prášek pro koncentrát pro infuzní roztok not available 15/793/16-C CZ PHARMA S.R.O. CZ

Vancomycin Olikla 1000 mg prášek pro koncentrát pro infuzní roztok not available 15/793/16-C CZ PHARMA S.R.O. CZ

Vancomycin Olikla 1000 mg prášek pro koncentrát pro infuzní roztok not available 15/793/16-C CZ PHARMA S.R.O. CZ

Vancomycin Olikla 1000 mg prášek pro koncentrát pro infuzní roztok not available 15/793/16-C CZ PHARMA S.R.O. CZ

Vancomycin Olikla 500 mg prášek pro koncentrát pro infuzní roztok not available 15/792/16-C CZ PHARMA S.R.O. CZ

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Olikla 500 mg prášek pro koncentrát pro infuzní roztok not available 15/792/16-C CZ PHARMA S.R.O. CZ

Vancomycin Olikla 500 mg prášek pro koncentrát pro infuzní roztok not available 15/792/16-C CZ PHARMA S.R.O. CZ

Vancomycin Olikla 500 mg prášek pro koncentrát pro infuzní roztok not available 15/792/16-C CZ PHARMA S.R.O. CZ

Vancomycin Orion 1 000 mg pulver till koncentrat till infusionsvätska, lösning FI/H/0845/002 31991 ORION CORPORATION FI

Vancomycin Orion 1000 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos FI/H/0845/002 31991 ORION CORPORATION FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Orion 1000 mg pulver till koncentrat till infusionsvätska, lösning FI/H/0845/002 50603 ORION CORPORATION SE

Vancomycin Orion 500 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos FI/H/0845/001 31990 ORION CORPORATION FI

Vancomycin Orion 500 mg pulver till koncentrat till infusionsvätska, lösning FI/H/0845/001 31990 ORION CORPORATION FI

Vancomycin Orion 500 mg pulver till koncentrat till infusionsvätska, lösning FI/H/0845/001 50602 ORION CORPORATION SE

Vancomycin Pfizer 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung AT/H/0876/002 1-30925

PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Pfizer 1000 mg pulver til konsentrat til infusjonsvæske, oppløsning. AT/H/0876/002 09-6844 PFIZER AS NO

Vancomycin Pfizer 1000 mg pulveris infūziju šķīduma koncentrāta pagatavošanai. AT/H/0876/002 11-0170 PFIZER EUROPE MA EEIG LV

Vancomycin Pfizer 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung AT/H/0876/001 1-30924

PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT

Vancomycin Pfizer 500 mg pulver til konsentrat til infusjonsvæske, oppløsning. AT/H/0876/001 09-6843 PFIZER AS NO

Vancomycin Pfizer 500 mg pulveris infūziju šķīduma koncentrāta pagatavošanai. AT/H/0876/001 11-0171 PFIZER EUROPE MA EEIG LV

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Sandoz 1000 mg infuusiokuiva-aine, liuosta varten NL/H/4445/002 24472 SANDOZ A/S FI

Vancomycin Sandoz 1000 mg powder for solution for infusion NL/H/4445/002 20100578

SANDOZ PHARMACEUTICALS D.D. BG

Vancomycin Sandoz 1000 mg, infusioonilahuse pulber NL/H/4445/002 658609

SANDOZ PHARMACEUTICALS D.D. EE

VANCOMYCIN SANDOZ 1000 MG, PROSZEK DO SPORZĄDZANIA ROZTWORU DO INFUZJI NL/H/4445/002 17021 SANDOZ GMBH PL

Vancomycin Sandoz 500 mg infuusiokuiva-aine, liuosta varten NL/H/4445/001 24471 SANDOZ A/S FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOMYCIN SANDOZ 500 MG, PROSZEK DO SPORZĄDZANIA ROZTWORU DO INFUZJI NL/H/4445/001 17020 SANDOZ GMBH PL

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 34093

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 125 mg hårda kapslar DK/H/2629/001 54527

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 125 mg harde kapsler DK/H/2629/001 16-11120

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 34094

STRIDES PHARMA (CYPRUS) LIMITED FI

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 250 mg hårda kapslar DK/H/2629/002 54528

STRIDES PHARMA (CYPRUS) LIMITED SE

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Strides 250 mg harde kapsler DK/H/2629/002 16-11121

STRIDES PHARMA (CYPRUS) LIMITED NO

Vancomycin Xellia 125 mg hårda kapslar not available 12243

XELLIA PHARMACEUTICALS APS SE

Vancomycin Xellia 125 mg hörð hylki. not available 940198

XELLIA PHARMACEUTICALS APS IS

Vancomycin Xellia 125 mg kapsel, hard not available 94-1817

XELLIA PHARMACEUTICALS APS NO

Vancomycin Xellia 125 mg, kapseli, kova not available 11660

XELLIA PHARMACEUTICALS APS FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin Xellia 250 mg hårda kapslar not available 12244

XELLIA PHARMACEUTICALS APS SE

Vancomycin Xellia 250 mg hörð hylki. not available 940199

XELLIA PHARMACEUTICALS APS IS

Vancomycin Xellia 250 mg, kapseli, kova not available 11661

XELLIA PHARMACEUTICALS APS FI

Vancomycin, 1000 mg Powder for concentrate for solution for infusion PT/H/0771/002 PL 15413/0008

HIKMA FARMACÊUTICA (PORTUGAL), S.A. UK

Vancomycin, 1000 mg Powder for concentrate for solution for infusion PT/H/0771/002 PL 15413/0008

HIKMA FARMACÊUTICA (PORTUGAL), S.A. UK

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin, 500 mg Powder for concentrate for solution for infusion PT/H/0771/001 PL 15413/0001

HIKMA FARMACÊUTICA (PORTUGAL), S.A. UK

Vancomycin, 500 mg Powder for concentrate for solution for infusion PT/H/0771/001 PL 15413/0001

HIKMA FARMACÊUTICA (PORTUGAL), S.A. UK

VANCOMYCIN/GENERICS 1 g, κόνις για διάλυμα προς έγχυση CZ/H/0351/002 73631/ 12-10-2016

GENERICS PHARMA HELLAS LTD GR

VANCOMYCIN/GENERICS 500 mg, κόνις για διάλυμα προς έγχυση CZ/H/0351/001 110870/ 14 / 12-10-2016

GENERICS PHARMA HELLAS LTD GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin/Kabi 1000mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση PT/H/2179/002 68431/15-09-2016 FRESENIUS KABI HELLAS A.E. GR

Vancomycin/Kabi 500 mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση PT/H/2179/001 67587/15-09-2016 FRESENIUS KABI HELLAS A.E. GR

Vancomycin/Noridem 1000 mg Κόνις για πυκνό σκεύασμα για Παρασκευή Διαλύματος προς Έγχυση. IE/H/0706/002 2827902 NORIDEM ENTERPRISES LTD GR

Vancomycin/Noridem 500 mg Κόνις για πυκνό σκεύασμα για Παρασκευή Διαλύματος προς Έγχυση IE/H/0706/001 2827901 NORIDEM ENTERPRISES LTD GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin/Norma® pd.sol.inf. 500mg/vial not available 44651/12/26-02-2013 NORMA HELLAS S.A. GR

Vancomycin/Vocate: 1g/Vial κόνις για διάλυμα προς έγχυση not available 94853/17/01-01-2018 VOCATE ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ GR

Vancomycin/Vocate: 500mg/Vial κόνις για διάλυμα προς έγχυση not available 93679/16/09-01-2018 VOCATE ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ GR

Vancomycin-CNP 1000 mg pulbere pentru solutie perfuzabila not available 7508/2015/01 CNP PHARMA GMBH RO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin-CNP 1000 mg pulbere pentru solutie perfuzabila not available 7508/2015/02 CNP PHARMA GMBH RO

Vancomycin-CNP 500 mg pulbere pentru soluţie perfuzabilă not available 7507/2015/01 CNP PHARMA GMBH RO

Vancomycin-CNP 500 mg pulbere pentru soluţie perfuzabilă not available 7507/2015/02 CNP PHARMA GMBH RO

Vancomycine Aurobindo 1000 mg, poeder voor concentraat voor oplossing voor infusie NL/H/4181/002 RVG 113555 AUROBINDO PHARMA B.V. NL

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine Aurobindo 500 mg, poeder voor concentraat voor oplossing voor infusie NL/H/4181/001 RVG 113830 AUROBINDO PHARMA B.V. NL

Vancomycine Fresenius Kabi 1000 mg poeder voor concentraat voor oplossing voor infusie PT/H/2179/002 BE398526 FRESENIUS KABI NV/SA BE

Vancomycine Fresenius Kabi 1000 mg poeder voor concentraat voor oplossing voor infusie. PT/H/2179/002 RVG 107977

FRESENIUS KABI NEDERLAND B.V. NL

Vancomycine Fresenius Kabi 1000 mg poudre pour solution à diluer pour perfusion PT/H/2179/002 BE398526 FRESENIUS KABI NV/SA BE

Vancomycine Fresenius Kabi 1000 mg Pulver zur Herstellung eines Konzentrats für eine Infusionslösung PT/H/2179/002 BE398526 FRESENIUS KABI NV/SA BE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine Fresenius Kabi 500 mg poeder voor concentraat voor oplossing voor infusie PT/H/2179/001 BE398517 FRESENIUS KABI NV/SA BE

Vancomycine Fresenius Kabi 500 mg poeder voor concentraat voor oplossing voor infusie. PT/H/2179/001 RVG 107976

FRESENIUS KABI NEDERLAND B.V. NL

Vancomycine Fresenius Kabi 500 mg poudre pour solution à diluer pour perfusion PT/H/2179/001 BE398517 FRESENIUS KABI NV/SA BE

Vancomycine Fresenius Kabi 500 mg Pulver zur Herstellung eines Konzentrats für eine Infusionslösung PT/H/2179/001 BE398517 FRESENIUS KABI NV/SA BE

VANCOMYCINE HIKMA 1000 mg, Poudre pour solution à diluer pour perfusion PT/H/0771/002 34009 585 364 10

HIKMA FARMACÊUTICA (PORTUGAL), S.A. FR

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOMYCINE HIKMA 1000 mg, Poudre pour solution à diluer pour perfusion PT/H/0771/002 34009 585 365 88

HIKMA FARMACÊUTICA (PORTUGAL), S.A. FR

VANCOMYCINE HIKMA 500 mg, Poudre pour solution à diluer pour perfusion PT/H/0771/001 34009 585 366 4 9

HIKMA FARMACÊUTICA (PORTUGAL), S.A. FR

VANCOMYCINE HIKMA 500 mg, Poudre pour solution à diluer pour perfusion PT/H/0771/001 34009 585 367 00

HIKMA FARMACÊUTICA (PORTUGAL), S.A. FR

Vancomycine Hikma, 1000 mg, Poeder voor concentraat voor oplossing voor infusie PT/H/0771/002 RVG 110476

HIKMA FARMACÊUTICA (PORTUGAL), S.A. NL

Vancomycine Hikma, 1000 mg, Poeder voor concentraat voor oplossing voor infusie PT/H/0771/002 RVG 110476

HIKMA FARMACÊUTICA (PORTUGAL), S.A. NL

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine Hikma, 500 mg, Poeder voor concentraat voor oplossing voor infusie PT/H/0771/001 RVG 110475

HIKMA FARMACÊUTICA (PORTUGAL), S.A. NL

Vancomycine Hikma, 500 mg, Poeder voor concentraat voor oplossing voor infusie PT/H/0771/001 RVG 110475

HIKMA FARMACÊUTICA (PORTUGAL), S.A. NL

VANCOMYCINE KABI 1 g, poudre pour solution injectable. not available 34009 563 783 1 9

FRESENIUS KABI FRANCE S.A.S. FR

VANCOMYCINE KABI 500 mg, poudre pour solution injectable. not available 34009 563 782 5 8

FRESENIUS KABI FRANCE S.A.S. FR

VANCOMYCINE MEDIPHA SANTE 1 g, poudre pour solution à diluer pour perfusion not available 34009 550 451 9 9 MEDIPHA SANTE FR

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National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOMYCINE MEDIPHA SANTE 1 g, poudre pour solution à diluer pour perfusion not available 34009 550 452 0 5 MEDIPHA SANTE FR

VANCOMYCINE MEDIPHA SANTE 500 mg, poudre pour solution à diluer pour perfusion not available 34009 550 451 6 8 MEDIPHA SANTE FR

VANCOMYCINE MEDIPHA SANTE 500 mg, poudre pour solution à diluer pour perfusion not available 34009 550 451 7 5 MEDIPHA SANTE FR

VANCOMYCINE MEDIPHA SANTE 500 mg, poudre pour solution à diluer pour perfusion not available 34009 550 451 8 2 MEDIPHA SANTE FR

Vancomycine MIP 1000 mg, poeder voor oplossing voor infusie FI/H/0889/002 RVG 114472 MIP PHARMA GMBH NL

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine MIP 1000 mg, poudre pour solution pour perfusion not available NL 39083, CIS : 6 500 547 9 MIP PHARMA GMBH FR

Vancomycine MIP 500 mg, poeder voor oplossing voor infusie FI/H/0889/001 RVG 114471 MIP PHARMA GMBH NL

Vancomycine MIP 500 mg, poudre pour solution pour perfusion not available NL 39082, CIS : 6 862 482 1 MIP PHARMA GMBH FR

Vancomycine Mylan 1 g poeder voor oplossing voor infusie CZ/H/0351/002 BE395437 MYLAN BVBA/SPRL BE

Vancomycine Mylan 1 g poudre pour solution pour perfusion CZ/H/0351/002 BE395437 MYLAN BVBA/SPRL BE

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine Mylan 1 g Pulver zur Herstellung einer Infusionslösung CZ/H/0351/002 BE395437 MYLAN BVBA/SPRL BE

Vancomycine Mylan 1 g, poudre pour solution pour perfusion not available NL 22242 MYLAN S.A.S FR

VANCOMYCINE MYLAN 125 mg, poudre pour solution à diluer pour perfusion not available NL 20620 MYLAN S.A.S FR

VANCOMYCINE MYLAN 250 mg, poudre pour solution à diluer pour perfusion not available NL 20621 MYLAN S.A.S FR

Vancomycine Mylan 500 mg poeder voor oplossing voor infusie CZ/H/0351/001 BE395421 MYLAN BVBA/SPRL BE

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine Mylan 500 mg poudre pour solution pour perfusion CZ/H/0351/001 BE395421 MYLAN BVBA/SPRL BE

Vancomycine Mylan 500 mg Pulver zur Herstellung einer Infusionslösung CZ/H/0351/001 BE395421 MYLAN BVBA/SPRL BE

VANCOMYCINE MYLAN 500 mg, poudre pour solution à diluer pour perfusion ou pour solution buvable not available NL 17209 MYLAN S.A.S FR

VANCOMYCINE MYLAN PHARMA 1000 mg, poudre pour solution à diluer pour perfusion SE/H/1158/002 NL42604 MYLAN S.A.S FR

VANCOMYCINE MYLAN PHARMA 500 mg, poudre pour solution à diluer pour perfusion SE/H/1158/001 NL42603 MYLAN S.A.S FR

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine Pfizer 1000 mg poeder voor concentraat voor oplossing voor infusie. AT/H/0876/002 RVG 105372 PFIZER B.V. NL

Vancomycine Pfizer 500 mg poeder voor concentraat voor oplossing voor infusie. AT/H/0876/001 RVG 105369 PFIZER B.V. NL

VANCOMYCINE SANDOZ 1 g, poudre pour solution à diluer pour perfusion not available 34009 559 330 6 9 SANDOZ FR

VANCOMYCINE SANDOZ 1 g, poudre pour solution à diluer pour perfusion not available 34009 560 804 8 9 SANDOZ FR

VANCOMYCINE SANDOZ 1 g, poudre pour solution à diluer pour perfusion not available 34009 563 234 8 7 SANDOZ FR

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOMYCINE SANDOZ 1 g, poudre pour solution à diluer pour perfusion not available 34009 563 235 4 8 SANDOZ FR

VANCOMYCINE SANDOZ 1 g, poudre pour solution à diluer pour perfusion not available 34009 566 134 4 1 SANDOZ FR

VANCOMYCINE SANDOZ 1 g, poudre pour solution à diluer pour perfusion not available 34009 566 140 4 2 SANDOZ FR

Vancomycine Sandoz 1000 mg poeder voor oplossing voor infusie NL/H/4445/002 BE361663 SANDOZ N.V. BE

Vancomycine Sandoz 1000 mg, poeder voor oplossing voor infusie NL/H/4445/002 RVG 101509 SANDOZ B.V. NL

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOMYCINE SANDOZ 125 mg, poudre pour solution à diluer pour perfusion not available 34009 559 334 1 0 SANDOZ FR

VANCOMYCINE SANDOZ 125 mg, poudre pour solution à diluer pour perfusion not available 34009 566 131 5 1 SANDOZ FR

VANCOMYCINE SANDOZ 250 mg, poudre pour solution à diluer pour perfusion not available 34009 566 132 1 2 SANDOZ FR

VANCOMYCINE SANDOZ 250 mg, poudre pour solution à diluer pour perfusion not available 34009 559 332 9 8 SANDOZ FR

Vancomycine Sandoz 500 mg poeder voor oplossing voor infusie NL/H/4445/001 BE361654 SANDOZ N.V. BE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycine Sandoz 500 mg, poeder voor oplossing voor infusie NL/H/4445/001 RVG 101505 SANDOZ B.V. NL

VANCOMYCINE SANDOZ 500 mg, poudre pour solution pour perfusion not available 34009 556 527 3 1 SANDOZ FR

VANCOMYCINE SANDOZ 500 mg, poudre pour solution pour perfusion not available 34009 566 133 8 0 SANDOZ FR

Vancomycin-HUMAN 50 mg/ml por oldatos infúzióhoz való koncentrátumhoz not available OGYI-T-7807/04 TEVA GYÓGYSZERGYÁR ZRT HU

Vancomycin-HUMAN 50 mg/ml por oldatos infúzióhoz való koncentrátumhoz not available OGYI-T-7807/01 TEVA GYÓGYSZERGYÁR ZRT HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin-HUMAN 50 mg/ml por oldatos infúzióhoz való koncentrátumhoz not available OGYI-T-7807/03 TEVA GYÓGYSZERGYÁR ZRT HU

Vancomycin-HUMAN 50 mg/ml por oldatos infúzióhoz való koncentrátumhoz not available OGYI-T-7807/02 TEVA GYÓGYSZERGYÁR ZRT HU

Vancomycin-MIP 1000 mg Pulver zur Herstellung einer Infusionslösung DE/H/0368/002 1-26310

MIP PHARMA AUSTRIA GMBH AT

Vancomycin–MIP 1000, 1 g, proszek do sporzadzania roztworu do infuzji i roztworu doustnego not available 10214

MIP PHARMA POLSKA SP. Z O.O. PL

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancomycin-MIP 500 mg Pulver zur Herstellung einer Infusionslösung DE/H/0368/001 1-26309

MIP PHARMA AUSTRIA GMBH AT

Vancomycin–MIP 500, 500 mg, proszek do sporzadzania roztworu do infuzji i roztworu doustnego not available 10213

MIP PHARMA POLSKA SP. Z O.O. PL

Vancomycin-Teva 1000 mg por oldatos infúzióhoz való koncentrátumhoz DE/H/5737/002 OGYI-T-23255/02 TEVA GYÓGYSZERGYÁR ZRT HU

Vancomycin-Teva 500 mg por oldatos infúzióhoz való koncentrátumhoz DE/H/5737/001 OGYI-T-23255/01 TEVA GYÓGYSZERGYÁR ZRT HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vanco-ratiopharm® 1000 mg Pulver zur Herstellung einer Infusionslösung DE/H/5737/002 82752.00.00 RATIOPHARM GMBH DE

Vanco-ratiopharm® 500 mg Pulver zur Herstellung einer Infusionslösung DE/H/5737/001 82751.00.00 RATIOPHARM GMBH DE

Vanco-saar® 1 g Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen not available 49101.01.00 MIP PHARMA GMBH DE

Vanco-saar® 500 mg Pulver zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen not available 39981.00.00 MIP PHARMA GMBH DE

Vancosan 1000 mg milteliai infuziniam tirpalui FI/H/0882/002 LT/1/11/2499/004 MIP PHARMA GMBH LT

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancosan 1000 mg milteliai infuziniam tirpalui FI/H/0882/002 LT/1/11/2499/006 MIP PHARMA GMBH LT

Vancosan 1000 mg milteliai infuziniam tirpalui FI/H/0882/002 LT/1/11/2499/003 MIP PHARMA GMBH LT

Vancosan 1000 mg Pulver zur Herstellung einer Infusionslösung FI/H/0882/002 81575.00.00 CNP PHARMA GMBH DE

Vancosan 1000 mg pulveris infūziju šķīduma pagatavošanai FI/H/0882/002 11-0190 MIP PHARMA GMBH LV

Vancosan 1000 mg, infusioonilahuse pulber FI/H/0882/002 740011 MIP PHARMA GMBH EE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancosan 1000 mg, Infuusiokuiva-aine, liuosta varten FI/H/0882/002 28526 MIP PHARMA GMBH FI

Vancosan 1000 mg, pulver till infusionsvätska, lösning FI/H/0882/002 28526 MIP PHARMA GMBH FI

Vancosan 500 mg milteliai infuziniam tirpalui FI/H/0882/001 LT/1/11/2499/002 MIP PHARMA GMBH LT

Vancosan 500 mg milteliai infuziniam tirpalui FI/H/0882/001 LT/1/11/2499/005 MIP PHARMA GMBH LT

Vancosan 500 mg milteliai infuziniam tirpalui FI/H/0882/001 LT/1/11/2499/001 MIP PHARMA GMBH LT

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancosan 500 mg Pulver zur Herstellung einer Infusionslösung FI/H/0882/001 81574.00.00 CNP PHARMA GMBH DE

Vancosan 500 mg pulveris infūziju šķīduma pagatavošanai FI/H/0882/001 11-0191 MIP PHARMA GMBH LV

Vancosan 500 mg, infusioonilahuse pulber FI/H/0882/001 740111 MIP PHARMA GMBH EE

Vancosan 500 mg, Infuusiokuiva-aine, liuosta varten FI/H/0882/001 28525 MIP PHARMA GMBH FI

Vancosan 500 mg, pulver till infusionsvätska, lösning FI/H/0882/001 28525 MIP PHARMA GMBH FI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vancosan oral 500 mg not available 49101.00.00 MIP PHARMA GMBH DE

VANCOTEN 500 mg, Κόνις για διάλυμα προς έγχυση PT/H/1371/001 76812/19-10-2016 ANFARM HELLAS SA GR

VANCOTEX 500 mg polvere per soluzione per infusione endovenosa e per soluzione orale not available 034632036 PHARMATEX ITALIA SRL IT

VANCOTEX 1 g polvere per soluzione per infusione endovenosa e per soluzione orale 1 flaconcino not available 034632024 PHARMATEX ITALIA SRL IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VANCOTEX 500 mg polvere per soluzione per infusione endovenosa e per soluzione orale 1 flaconcino not available 034632012 PHARMATEX ITALIA SRL IT

Vangrotin, 500 mg, pó para solução para perfusão PT/H/1371/001 PT/H/1371/001 ANFARM HELLAS SA PT

Vankomicin Apta 1000 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/002 H/16/02192/005

APTA MEDICA INTERNACIONAL D.O.O. SI

Vankomicin Apta 1000 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/002 H/16/02192/006

APTA MEDICA INTERNACIONAL D.O.O. SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vankomicin Apta 1000 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/002 H/16/02192/007

APTA MEDICA INTERNACIONAL D.O.O. SI

Vankomicin Apta 1000 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/002 H/16/02192/008

APTA MEDICA INTERNACIONAL D.O.O. SI

Vankomicin Apta 500 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/001 H/16/02192/001

APTA MEDICA INTERNACIONAL D.O.O. SI

Vankomicin Apta 500 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/001 H/16/02192/002

APTA MEDICA INTERNACIONAL D.O.O. SI

Vankomicin Apta 500 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/001 H/16/02192/003

APTA MEDICA INTERNACIONAL D.O.O. SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vankomicin Apta 500 mg prašek za koncentrat za raztopino za infundiranje PT/H/1401/001 H/16/02192/004

APTA MEDICA INTERNACIONAL D.O.O. SI

Vankomicin Kabi 1 g prašek za koncentrat za raztopino za infundiranje PT/H/2179/002 H/11/01613/003

FRESENIUS KABI DEUTSCHLAND GMBH SI

Vankomicin Kabi 1 g prašek za koncentrat za raztopino za infundiranje PT/H/2179/002 H/11/01613/004

FRESENIUS KABI DEUTSCHLAND GMBH SI

Vankomicin Kabi 500 mg prašek za koncentrat za raztopino za infundiranje PT/H/2179/001 H/11/01613/001

FRESENIUS KABI DEUTSCHLAND GMBH SI

Vankomicin Kabi 500 mg prašek za koncentrat za raztopino za infundiranje PT/H/2179/001 H/11/01613/002

FRESENIUS KABI DEUTSCHLAND GMBH SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vankomicin Lek 1000 mg prašek za raztopino za infundiranje NL/H/4445/002 H/10/01611/005

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Vankomicin Lek 1000 mg prašek za raztopino za infundiranje NL/H/4445/002 H/10/01611/006

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Vankomicin Lek 1000 mg prašek za raztopino za infundiranje NL/H/4445/002 H/10/01611/007

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Vankomicin Lek 1000 mg prašek za raztopino za infundiranje NL/H/4445/002 H/10/01611/008

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Vankomicin Lek 500 mg prašek za raztopino za infundiranje NL/H/4445/001 H/10/01611/001

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vankomicin Lek 500 mg prašek za raztopino za infundiranje NL/H/4445/001 H/10/01611/002

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Vankomicin Lek 500 mg prašek za raztopino za infundiranje NL/H/4445/001 H/10/01611/003

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Vankomicin Lek 500 mg prašek za raztopino za infundiranje NL/H/4445/001 H/10/01611/004

LEK PHARMACEUTICALS D.D. LJUBLJANA SI

Vankomicin MIP 1000 mg prašak za otopinu za infuziju FI/H/0889/002 HR-H-126592758

MIP PHARMA CROATIA D.O.O. HR

Vankomicin MIP 500 mg prašak za otopinu za infuziju FI/H/0889/001 HR-H-949322881

MIP PHARMA CROATIA D.O.O. HR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vankomicin Mylan 1000 mg prašek za raztopino za infundiranje CZ/H/0351/002 H/11/01614/001 MYLAN S.A.S SI

Vankomicin Mylan 1000 mg prašek za raztopino za infundiranje CZ/H/0351/002 H/11/01614/002 MYLAN S.A.S SI

Vankomicin Mylan 1000 mg prašek za raztopino za infundiranje CZ/H/0351/002 H/11/01614/003 MYLAN S.A.S SI

Vankomicin Mylan 1000 mg prašek za raztopino za infundiranje CZ/H/0351/002 H/11/01614/004 MYLAN S.A.S SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vankomicin Mylan Pharma 1000 mg prašek za koncentrat za raztopino za infundiranje SE/H/1158/002 H/13/01612/002 MYLAN S.A.S SI

Vankomicin Mylan Pharma 500 mg prašek za koncentrat za raztopino za infundiranje SE/H/1158/001 H/13/01612/001 MYLAN S.A.S SI

Vankomicin Pfizer 1000 mg prašek za koncentrat za raztopino za infundiranje AT/H/0876/002 H/11/01615/005 PFIZER LUXEMBOURG SARL SI

Vankomicin Pfizer 1000 mg prašek za koncentrat za raztopino za infundiranje AT/H/0876/002 H/11/01615/004 PFIZER LUXEMBOURG SARL SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Vankomicin Pfizer 1000 mg prašek za koncentrat za raztopino za infundiranje AT/H/0876/002 H/11/01615/006 PFIZER LUXEMBOURG SARL SI

Vankomicin Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje AT/H/0876/001 H/11/01615/003 PFIZER LUXEMBOURG SARL SI

Vankomicin Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje AT/H/0876/001 H/11/01615/001 PFIZER LUXEMBOURG SARL SI

Vankomicin Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje AT/H/0876/001 H/11/01615/002 PFIZER LUXEMBOURG SARL SI

VONCON® 500 mg Κόνις για διάλυμα προς έγχυση not available 58858/13/21-11-2014 PHARMASERVE-LILLY SACI GR

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

VONDEM not available 38055/10 DEMO ABEE GR

VONDEM not available 2694202 DEMO ABEE GR

VOXIN® not available AA721/00501 VIANEX S.A. MT

VOXIN® 500mg/VIAL Κόνις για διάλυμα προς έγχυση not available 66706/17-12-2019 VIANEX S.A. GR

VOXIN® Κόνις για διάλυμα προς έγχυση 1g/VIAL not available 66375/17-12-2019 VIANEX S.A. GR

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

ZENGAC “500 mg Polvere per soluzione per infusione e per uso orale” not available 034634030 FISIOPHARMA SRL IT

ZENGAC 1 g Polvere per soluzione per infusione e per uso orale not available 034634028 FISIOPHARMA SRL IT

Ванкомицин Бендалис 1000 mg прах за инфузионен разтвор not available 20130237 BENDALIS GMBH BG

Ванкомицин Бендалис 500 mg прах за инфузионен разтвор not available 20130238 BENDALIS GMBH BG

Ванкомицин Каби 1000 mg прах за концентрат за инфузионен разтвор PT/H/2179/002 20130138

FRESENIUS KABI BULGARIA EOOD BG

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MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Ванкомицин Каби 500 mg прах за концентрат за инфузионен разтвор PT/H/2179/001 20130137

FRESENIUS KABI BULGARIA EOOD BG

Ванкомицин-MIP 1000 mg прах за инфузионен разтвор not available 20060707 MIP PHARMA GMBH BG

Ванкомицин-MIP 500 mg прах за инфузионен разтвор not available 20060706 MIP PHARMA GMBH BG

Ванкоцин CP 1 g прах за инфузионен разтвор not available 20000363

TCHAIKAPHARMA HIGH QUALITY MEDICINES, INC. BG