vancomycin: list of nationally authorised medicinal products - … · edicin 0,5 g prašak za...
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© 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 25/123
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 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
List of nationally authorised medicinal products EMA/647607/2020 Page 26/123
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 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
List of nationally authorised medicinal products EMA/647607/2020 Page 27/123
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 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
List of nationally authorised medicinal products EMA/647607/2020 Page 28/123
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 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
List of nationally authorised medicinal products EMA/647607/2020 Page 29/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 30/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 31/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 32/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 33/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 34/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 35/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 36/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 37/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 38/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 39/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 40/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 41/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 42/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 43/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 44/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 45/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 46/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 47/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 48/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 49/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 50/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 51/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 52/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 53/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 54/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 56/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 57/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 58/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 59/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 61/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 74/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 75/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 78/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 83/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 85/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 86/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 87/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 93/123
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
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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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 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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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 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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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 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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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 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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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 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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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 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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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 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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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 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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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 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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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 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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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 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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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 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
List of nationally authorised medicinal products EMA/647607/2020 Page 117/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 118/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 119/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 120/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 121/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 122/123
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
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
List of nationally authorised medicinal products EMA/647607/2020 Page 123/123
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
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