active substance: hydrocortisone (except for products ...€¦ · locoÏd, lotion not available...

26
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 30 April 2020 EMA/311363/2020 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet formulation) Procedure no.: PSUSA/00010328/201908

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Page 1: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

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

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

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

30 April 2020 EMA/311363/2020 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet formulation)

Procedure no.: PSUSA/00010328/201908

Page 2: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

List of nationally authorised medicinal products EMA/311363/2020 Page 2/26

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

Colifoam 100 mg/dos rektalskum not available 8625 MEDA OY FI Colifoam 100 mg/annos rektaalivaahto not available 8625 MEDA OY FI oralsone adultos 2,5 mg comprimidos para chupar

not available 32.690 LABORATORIOS VIÑAS, S.A. ES

Hydrocortisone Orion 10 mg tabletit FI/H/0822/001 31460 ORION OYJ FI Hydrocortisone Orion 10 mg tabletter FI/H/0822/001 31460 ORION OYJ FI Hydrokortison ”Orion”, tabletter FI/H/0822/001 52357 ORION CORPORATION DK Hydrokortison Orion 10 mg tabletter FI/H/0822/001 49341 ORION CORPORATION SE Hydrokortison Orion 10 mg töflur FI/H/0822/001 IS/1/15/043/01 ORION CORPORATION IS Hikomicron 10 mg/g gél not available OGYI-T-20463/01 PANNONPHARMA KFT. HU Hikomicron 25 mg/g gél not available OGYI-T-20463/02 PANNONPHARMA KFT. HU Hikomicron 25 mg/g gél not available OGYI-T-20463/03 PANNONPHARMA KFT. HU LOCOID 0,1%, krém not available 46/896/92-C LEO PHARMA A/S CZ LOCOID 0,1%, mast not available 46/893/92-C LEO PHARMA A/S CZ LOCOID CRELO 0,1%, kožní emulze not available 46/013/96-C LEO PHARMA A/S CZ LOCOID 0,1% LOTION, kožní roztok not available 46/142/93-C LEO PHARMA A/S CZ LOCOID LIPOCREAM 0,1%, krém not available 46/097/93-C LEO PHARMA A/S CZ Hidrocisdin 5mg/g Espuma Cutánea not available 60.890 ISDIN, S.A. ES CORTIDRO “0,5% crema” not available 010318032 SOFAR S.P.A. IT Boots Derma Care Hydrocortisone 1% Ointment

not available PL 00014/0364 THE BOOTS COMPANY PLC UK

Almus Hydrocortisone 1% Ointment not available PL 00014/0364 THE BOOTS COMPANY PLC UK Hydrocortisone Ointment not available PL 00014/0364 THE BOOTS COMPANY PLC UK Hydrocortisone Skin Ointment 1% not available PL 04416/0255 SANDOZ LTD UK Solu-Cortef Powder for Solution for Injection or Infusion 100 mg

not available PA 0822/137/001 PFIZER HEALTHCARE IRELAND IE

Hydrocortisone 1.0 % M/m Ointment not available PL 00289/0757 TEVA UK LIMITED UK

Page 3: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

List of nationally authorised medicinal products EMA/311363/2020 Page 3/26

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

Hydrocortisone 2.5%m/m Ointment not available PL 00289/0758 TEVA UK LIMITED UK Hydrocortisone 0.5%m/m Ointment not available PL 00289/0756 TEVA UK LIMITED UK LOCOID 0,1%, crème not available 34009 321 895 2 6 LEO PHARMA A/S FR LOCOID 0,1%, crème not available 34009 321 896 9 4 LEO PHARMA A/S FR LOCOÏD, crème épaisse pour application locale

not available 34009 327 851 7 9 LEO PHARMA A/S FR

LOCOÏD 0,1%, émulsion fluide pour application locale

not available 34009 336 849 1 4 LEO PHARMA A/S FR

LOCOÏD 0,1%, émulsion fluide pour application locale

not available 34009 336 848 5 3 LEO PHARMA A/S FR

LOCOÏD, pommade not available 34009 321 901 2 6 LEO PHARMA A/S FR LOCOÏD, pommade not available 34009 321 902 9 4 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 327 248 9 5 LEO PHARMA A/S FR HYDRACORT 0,5 POUR CENT, crème not available 329 723-6 GALDERMA INTERNATIONAL FR HYDRACORT 0,5 POUR CENT, crème not available 329 724-2 GALDERMA INTERNATIONAL FR Solu-Cortef, 100 mg süstelahuse pulber ja lahusti

not available 057094 PFIZER EUROPE MA EEIG EE

FOILLE INSETTI 0,5 g/100 g crema not available 020051037 VEMEDIA MANUFACTURING B. V.

IT

Colifoam, rektalskum not available 10345 MYLAN DENMARK APS DK Ebenol® Spray 0,5 % Lösung not available 58937.00.00 STRATHMANN GMBH & CO. KG DE Systral Hydrocort 0,25 % Emulsion not available 6079645.00.00 MEDA PHARMA GMBH & CO. KG DE HYDROCORTISONE ROUSSEL 100 MG, POUDRE ET SOLVANT POUR SOLUTION INJECTABLE

not available 34009 305 139 2 7 SANOFI-AVENTIS FRANCE FR

Page 4: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

List of nationally authorised medicinal products EMA/311363/2020 Page 4/26

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

HYDROCORTISONE ROUSSEL 100 MG, POUDRE ET SOLVANT POUR SOLUTION INJECTABLE

not available 34009 550 562 1 8 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 10 MG, COMPRIME SECABLE

not available 34009 305 141 7 7 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 10 MG, COMPRIME SECABLE

not available 34009 575 304 6 4 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 550 559-0 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 550 560-9 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 305 145-2 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 305 147-5 SANOFI-AVENTIS FRANCE FR

Colifoam - Rektalschaum not available 1-18460 MEDA PHARMA GMBH AT Lactisona 10 mg/ml emulsión cutánea not available 59.709 STIEFEL FARMA, S.A. ES Fenistil Hydrocort Spray 0,5% Hydrocortison 5 mg/g Spray zur Anwendung auf der Haut, Lösung bei Erwachsenen und Kindern ab dem vollendeten 6. Lebensjahr

not available 58936.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG

DE

Locoid 0,1% kräm not available 9253 LEO PHARMA A/S SE Locoid Lipid 0,1% kräm not available 10218 LEO PHARMA A/S SE Locoid 0,1% salva not available 9255 LEO PHARMA A/S SE Locoid Crelo 0,1% kutan emulsion not available 11906 LEO PHARMA A/S SE

Page 5: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

List of nationally authorised medicinal products EMA/311363/2020 Page 5/26

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

Locoid 0,1% kutan lösning not available 9254 LEO PHARMA A/S SE SINTOTRAT 0,5% crema 1 Tubo da 20 g not available 025753017 DOMPÉ FARMACEUTICI S.P.A. IT HYDROCORTISYL SKIN CREAM 1% not available MA082/01201 SANOFI MALTA LTD MT Ebenol ® 0,25 % Creme not available 57573.00.00 STRATHMANN GMBH & CO. KG DE Solu-Cortef 50 mg/ml por és oldószer oldatos injekcióhoz

not available OGYI-T-1859/01 PFIZER KFT. HU

Solu-Cortef 100 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

not available H/93/01439/001 PFIZER LUXEMBOURG SARL SI

Solu-Cortef 500 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

not available H/93/01439/002 PFIZER LUXEMBOURG SARL SI

LOCOID 0,1 % voide not available 6771 LEO PHARMA A/S FI Locoid 0,1% salva not available 6771 LEO PHARMA A/S FI LOCOID 0,1 % emulsiovoide not available 6770 LEO PHARMA A/S FI Locoid 0,1 % kräm not available 6770 LEO PHARMA A/S FI LOCOID 0,1 % liuos iholle not available 6772 LEO PHARMA A/S FI Locoid 0,1% kutan lösning not available 6772 LEO PHARMA A/S FI LOCOID LIPID 0,1 % emulsiovoide not available 8784 LEO PHARMA A/S FI Locoid Lipid 0,1% kräm not available 8784 LEO PHARMA A/S FI LOCOID CRELO 0,1 % emulsio iholle not available 11108 LEO PHARMA A/S FI Locoid Crelo 0,1% kutan emulsion not available 11108 LEO PHARMA A/S FI Hydrocortison-POS N 2,5 %, Augensalbe

not available 86298.00.00 URSAPHARM ARZNEIMITTEL GMBH

DE

CORTEF 10 mg tablete not available HR-H-281556040 PFIZER CROATIA D.O.O. HR PANNOCORT 1 % crème not available BE053392 PANNOC CHEMIE NV BE PANNOCORT 1 % crème not available BE053392 PANNOC CHEMIE NV BE PANNOCORT 1% crème not available BE511244 PANNOC CHEMIE NV BE PANNOCORT 1% crème not available BE511244 PANNOC CHEMIE NV BE

Page 6: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

List of nationally authorised medicinal products EMA/311363/2020 Page 6/26

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

PANNOCORT 1% crème not available 1982060111 PANNOC CHEMIE NV LU Hydrocortone 10 mg Tablets not available PA1986/054/001 TEVA B.V IE LENIRIT 0,5% Crema not available 025869013 EG S.P.A. IT EFFICORT LIPOPHILE 0,127 %, crème not available 34009 331 221 4 0 LABORATOIRES BAILLEUL SA FR EFFICORT LIPOPHILE 0,127 %, crème not available 34009 330 690 0 1 LABORATOIRES BAILLEUL SA FR EFFICORT HYDROPHILE 0,127 %, crème

not available 34009 331 222 0 1 LABORATOIRES BAILLEUL SA FR

EFFICORT HYDROPHILE 0,127 %, crème

not available 34009 330 691 7 9 LABORATOIRES BAILLEUL SA FR

EFFICORT HYDROPHILE 0,127 %, crème

not available 34009 342 372 9 4 LABORATOIRES BAILLEUL SA FR

EFFICORT HYDROPHILE 0,127 %, crème

not available 34009 342 373 5 5 LABORATOIRES BAILLEUL SA FR

Suniderma 1,27 mg/g crema not available 58.851 LABORATOIRES BAILLEUL SA ES Suniderma 1,27 mg/g crema not available 58.851 LABORATOIRES BAILLEUL SA ES Suniderma 1,27 mg/g pomada not available 58.852 LABORATOIRES BAILLEUL SA ES Suniderma 1,27 mg/g pomada not available 58.852 LABORATOIRES BAILLEUL SA ES Soventol Hydrocortisonacetat 0,25 % 2,5 mg/g Creme

not available 6899377.00.00 MEDICE PHARMA GMBH & CO. KG

DE

Soventol Hydrocortisonacetat 0,25 % 2,5 mg/g Creme

not available 6462458.00.00 MEDICE PHARMA GMBH & CO. KG

DE

HYDROCORTISONE ROUSSEL 100 MG, POUDRE ET SOLVANT POUR SOLUTION INJECTABLE

not available 34009 305 139 2 7 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 100 MG, POUDRE ET SOLVANT POUR SOLUTION INJECTABLE

not available 34009 550 562 1 8 SANOFI-AVENTIS FRANCE FR

Page 7: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

List of nationally authorised medicinal products EMA/311363/2020 Page 7/26

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

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 550 559-0 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 550 560-9 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 305 145-2 SANOFI-AVENTIS FRANCE FR

HYDROCORTISONE ROUSSEL 2,5 %, SUSPENSION INJECTABLE

not available 305 147-5 SANOFI-AVENTIS FRANCE FR

Locoid 0,1% krem not available 6156 LEO PHARMA A/S NO Locoid Lipid 0,1% krem not available 7339 LEO PHARMA A/S NO Locoid Crelo 0,1% liniment, emulsjon not available 7919 LEO PHARMA A/S NO Locoid 0,1% Liniment, oppløsning not available 6157 LEO PHARMA A/S NO Locoid 0,1% salve not available 6158 LEO PHARMA A/S NO RAPICORT 100 mg/2 ml polvere e solvente per soluzione iniettabile

not available 026800033 MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A.

IT

RAPICORT 100 mg/2 ml polvere e solvente per soluzione iniettabile

not available 026800058 MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A.

IT

RAPICORT 100 mg/2 ml polvere e solvente per soluzione iniettabile

not available 026800060 MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A.

IT

HYDROCORTISYL SKIN CREAM 1% not available PA 540/46/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI

IE

Mildison Lipid 1% kräm not available 10829 KARO PHARMA AB SE Solu-Cortef S.A.B. Act-O-Vial 500 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available BE061476 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 500 mg Pulver zur not available BE193295 PFIZER S.A. (BELGIUM) BE

Page 8: Active substance: hydrocortisone (except for products ...€¦ · LOCOÏD, lotion not available 34009 321 892 3 6 LEO PHARMA A/S FR LOCOÏD, lotion not available 34009 321 894 6 5

List of nationally authorised medicinal products EMA/311363/2020 Page 8/26

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

Herstellung einer Injektionslösung Solu-Cortef S.A.B. Act-O-Vial 100 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available BE061311 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 250 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available BE061451 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 100 mg Pulver zur Herstellung einer Injektionslösung

not available BE193277 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 500 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available BE061476 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 250 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available BE061451 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 100 mg Poudre pour solution injectable

not available BE193277 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 100 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available BE061311 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 500 mg Poudre pour solution injectable

not available BE193295 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 500 mg not available BE061476 PFIZER S.A. (BELGIUM) BE

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List of nationally authorised medicinal products EMA/311363/2020 Page 9/26

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

Poeder en oplosmiddel voor oplossing voor injectie (S.A.B. = Sine Alcohol Benzylicus) Solu-Cortef S.A.B. Act-O-Vial 100 mg Poeder en oplosmiddel voor oplossing voor injectie (S.A.B. = Sine Alcohol Benzylicus)

not available BE061311 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 500 mg Poeder voor oplossing voor injectie

not available BE193295 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 100 mg Poeder voor oplossing voor injectie

not available BE193277 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 250 mg Poeder en oplosmiddel voor oplossing voor injectie (S.A.B. = Sine Alcohol Benzylicus)

not available BE061451 PFIZER S.A. (BELGIUM) BE

K & P Hydrocortison 1% Creme Hydrocortison 10 mg/g

not available 54735.02.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG

DE

Hc45 Hydrocortisone Cream not available PL 00063/0647 RECKITT BENCKISER HEALTHCARE (UK) LTD

UK

Solu-Cortef, pulver og solvens til injektionsvæske, opløsning

not available 1650 PFIZER APS DK

Solu-Cortef, pulver og solvens til injektionsvæske, opløsning

not available 5089 PFIZER APS DK

Locoid not available 5996 LEO PHARMA A/S DK Locoid Crelo not available 15036 LEO PHARMA A/S DK Locoid not available 5995 LEO PHARMA A/S DK Locoid Lipid not available 11000 LEO PHARMA A/S DK Locoid not available 5994 LEO PHARMA A/S DK

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List of nationally authorised medicinal products EMA/311363/2020 Page 10/26

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

CORTIZI 3.35 mg/ml not available 59416/14-12-2017 VERISFIELD (UK) LTD GR COLIFOAM 10 g/100 g, schiuma rettale not available 027000013 MEDA PHARMA S.P.A. IT NEURODERM® AKUT 0,1 % Creme not available 7980.00.00 INFECTOPHARM ARZNEIMITTEL

UND CONSILIUM GMBH DE

Hydrocortisone Cream 1% not available PL 06464/0698 WAYMADE PLC UK Efcortesol Injection not available PL 20072/0229 AMDIPHARM UK LIMITED UK Hydrocortisone 100mg/ml solution for injection

not available PL 20072/0229 AMDIPHARM UK LIMITED UK

Hydrocortisone 500mg/5ml solution for injection

not available PL 20072/0229 AMDIPHARM UK LIMITED UK

HYDROCORTONE not available 8969410 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA

PT

HYDROCORTONE not available 8969402 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA

PT

Solu-Cortef, pulver og solvens til injektionsvæske, opløsning

not available 1650 PFIZER APS DK

Solu-Cortef, pulver og solvens til injektionsvæske, opløsning

not available 5089 PFIZER APS DK

Cortef 10 mg tabletta not available OGYI-T-9856/01 PFIZER KFT. HU Cortef 10 mg tabletta not available OGYI-T-9856/02 PFIZER KFT. HU Locoid Crelo 1 mg/g emulsie cutanată not available 8669/2016/01 LEO PHARMA A/S RO Locoid 1 mg/g soluţie cutanată not available 8701/2016/01 LEO PHARMA A/S RO Locoid Lipocream 1 mg/g cremă not available 8684/2016/01 LEO PHARMA A/S RO Locoid 1 mg/g cremă not available 8683/2016/01 LEO PHARMA A/S RO Locoidon crelo® 1 mg/g dermalna not available H/00/00934/001 LEO PHARMA A/S SI

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List of nationally authorised medicinal products EMA/311363/2020 Page 11/26

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

emulzija Locoidon lipocrema 1 mg/g krema not available H/00/00934/002 LEO PHARMA A/S SI Locoid cream not available PL 05293/0010 LEO PHARMA A/S UK Locoid Ointment not available PL 05293/0013 LEO PHARMA A/S UK Locoid Lipocream not available PL 05293/0012 LEO PHARMA A/S UK Locoid Crelo not available PL 05293/0011 LEO PHARMA A/S UK Locoid Scalp Lotion not available PL 05293/0014 LEO PHARMA A/S UK Локоид Липокрем 0,1% крем not available 20000282 LEO PHARMA A/S BG Локоид Крело 0.1% емулсия за кожа not available 20000283 LEO PHARMA A/S BG HYDROCORTISONE BePB 20 mg comprimés

not available BE030755 BEPHARBEL MANUFACTURING S.A.

BE

HYDROCORTISONE BePB 20 mg tabletten

not available BE030755 BEPHARBEL MANUFACTURING S.A.

BE

HYDROCORTISONE BePB 20 mg comprimés

not available 2008100049 BEPHARBEL MANUFACTURING S.A.

LU

HYDROCORTISONE BePB 20 mg Tabletten

not available BE030755 BEPHARBEL MANUFACTURING S.A.

BE

CORTAPAISYL 0,5%, crème not available 279 018 2 9 MERCK MÉDICATION FAMILIALE S.A.S.

FR

CORTAPAISYL 0,5%, crème not available 357 566 9 5 MERCK MÉDICATION FAMILIALE S.A.S.

FR

CORTAPAISYL 0,5%, crème not available 357 565 2 7 MERCK MÉDICATION FAMILIALE S.A.S.

FR

HYDROCORTISONE UPJOHN 500 mg, préparation injectable

not available 34009 321 409 0 9 SERB FR

HYDROCORTISONE UPJOHN 500 mg, préparation injectable

not available 34009 321 410 9 8 SERB FR

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List of nationally authorised medicinal products EMA/311363/2020 Page 12/26

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

HYDROCORTISONE UPJOHN 500 mg, préparation injectable

not available 34009 337 316 7 0 SERB FR

HYDROCORTISONE UPJOHN 500 mg, préparation injectable

not available 34009 337 317 3 1 SERB FR

Solu-Cortef 250 mg stungulyfsstofn og leysir, lausn

not available 699001 PFIZER APS IS

Solu-Cortef 100 mg stungulyfsstofn og leysir, lausn

not available 691223 PFIZER APS IS

PANDEL, 1 mg/g, creme not available 9774505 ISDIN LDA PT Hydrocortison-POS N 1 %, Augensalbe not available 86297.00.00 URSAPHARM ARZNEIMITTEL

GMBH DE

Dioderm 0.1% w/w Cream not available PA 278/3/1 DERMAL LABORATORIES LIMITED

IE

Hydrocortisone 20 mg Tablets not available PL 06464/0701 WAYMADE PLC UK Solu-Cortef, poeder voor injectievloeistof, 100 mg

not available RVG 00608 PFIZER B.V. NL

Solu-Cortef, poeder voor injectievloeistof, 100 mg + oplosmiddel (“Act-O-Vial”)

not available RVG 14871 PFIZER B.V. NL

Locoidon 0,1% crema Idrocortisone 17-butirrato

not available 023325057 LEO PHARMA A/S IT

Locoidon 0,1% unguento Idrocortisone 17-butirrato

not available 023325018 LEO PHARMA A/S IT

Locoidon 0,1% emulsione cutanea Idrocortisone 17-butirrato

not available 23325083 LEO PHARMA A/S IT

Locoidon 0,1% soluzione cutanea Idrocortisone 17-butirrato

not available 023325044 LEO PHARMA A/S IT

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List of nationally authorised medicinal products EMA/311363/2020 Page 13/26

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

Locoidon 0,1% crema idrofila not available 023325020 LEO PHARMA A/S IT Colifoam rektalskum not available 12306 MEDA AB SE Hydrocortison-ratiopharm® 0,5 % Spray Spray zur Anwendung auf der Haut, Lösung Für Kinder ab 6 Jahren und Erwachsene

not available 58934.00.00 RATIOPHARM GMBH DE

Hydventia 10 mg Tablets not available PL 10321/0210 RESOLUTION CHEMICALS LIMITED

UK

Hydventia 20 mg Tablets not available PL 10321/0211 RESOLUTION CHEMICALS LIMITED

UK

Hydrocortisone 10 mg Tablets not available PL 20072/0238 AMDIPHARM UK LIMITED UK Solu-Cortef 1 g pulver och vätska till injektionsvätska, lösning

not available 46055 PFIZER AB SE

Solu-Cortef 250 mg pulver och vätska till injektionsvätska, lösning

not available 80031 PFIZER AB SE

Solu-Cortef 100 mg pulver och vätska till injektionsvätska, lösning

not available 05561 PFIZER AB SE

Locoid 1mg/g pomada not available 8395418 LEO PHARMA A/S PT Locoid 1mg/g pomada not available 8395400 LEO PHARMA A/S PT Locoid Capilar 1mg/ml solução cutânea not available 8395509 LEO PHARMA A/S PT Locoid Crelo 1 mg/g emulsão cutânea not available 2432680 LEO PHARMA A/S PT Locoid 1mg/g creme not available 8395319 LEO PHARMA A/S PT Locoid 1mg/g creme not available 8395301 LEO PHARMA A/S PT Locoid Lipocreme 1mg/g creme not available 8640508 LEO PHARMA A/S PT LOCOID 0,1 % dermálny krém not available 46/0896/92-C/S LEO PHARMA A/S SK LOCOID CRELO dermálna emulzia not available 46/0527/96-S LEO PHARMA A/S SK LOCOID LIPOCREAM 0,1 % dermálny not available 46/0382/95-S LEO PHARMA A/S SK

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List of nationally authorised medicinal products EMA/311363/2020 Page 14/26

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

krém LOCOID 0,1 % dermálna masť not available 46/0893/92-C/S LEO PHARMA A/S SK Hydrocortisone 10 mg Tablets FI/H/0822/001 PL 30322/0015 ALISSA HEALTHCARE

RESEARCH LIMITED UK

Solu-Cortef, 100 mg süstelahuse pulber ja lahusti

not available 057094 PFIZER EUROPE MA EEIG EE

SOLU-CORTEF 100 mg prašak i otapalo za otopinu za injekciju/infuziju

not available HR-H-226141869 PFIZER CROATIA D.O.O. HR

Locoid, 1 mg/ml, roztwór na skórę not available R/2592 LEO PHARMA A/S PL Locoid Crelo, 1 mg/g, emulsja not available R/6919 LEO PHARMA A/S PL Locoid Lipocream, 1 mg/g, krem not available R/1915 LEO PHARMA A/S PL Locoid, 1 mg/g, krem not available R/2591 LEO PHARMA A/S PL Colifoam 10% w/w, ορθικός αφρός not available 40106/10/27-05-2011 MEDA PHARMACEUTICALS S.A. GR Hydrocortisone 20 mg Tablets UK/H/5777/002 PL 20046/0303 FOCUS PHARMACEUTICALS

LIMITED UK

Hydrocortisone 10 mg Tablets UK/H/5777/001 PL 20046/0302 FOCUS PHARMACEUTICALS LIMITED

UK

LOCOID 0,1% CREME not available BE052342 LEO PHARMA A/S BE LOCOID 0,1% LIPOCREME crème not available BE129841 LEO PHARMA A/S BE LOCOID LIPOCREME 0,1% crème not available BE129841 LEO PHARMA A/S BE LOCOID LIPOCREME 0,1% CREME not available BE129841 LEO PHARMA A/S BE LOCOID 0,1% crème not available BE052342 LEO PHARMA A/S BE LOCOID 0,1% crème not available BE052342 LEO PHARMA A/S BE LOCOID CRELO 0,1% émulsion pour application cutanée

not available BE164981 LEO PHARMA A/S BE

LOCOID CRELO 0,1% emulsie voor cutaan gebruik

not available BE164981 LEO PHARMA A/S BE

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List of nationally authorised medicinal products EMA/311363/2020 Page 15/26

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

LOCOID CRELO 0,1% EMULSION ZUR ANWENDUNG AUF DER HAUT

not available BE164981 LEO PHARMA A/S BE

Mildison Lipid, creme not available 13158 KARO PHARMA AB DK Mildison Lipid 1% krem. not available 870171 KARO PHARMA AB IS SOLU-CORTEF 100 mg pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

not available 96-0062 PFIZER EUROPE MA EEIG LV

Ebenol® 0.5% cream not available 57573.01.00 STRATHMANN GMBH & CO. KG DE Dermocortal 5 mg/g crema not available 025774011 LABORATORIO FARMACEUTICO

S.I.T. S.R.L. IT

HYDROCORTISON TAKEDA 1 % -gel not available 13838 TAKEDA OY FI HYDROCORTISON TAKEDA 1 % -geeli not available 13838 TAKEDA OY FI Actocortina 500 mg polvo para solución inyectable

not available 52105 TAKEDA FARMACÉUTICA ESPAÑA S.A

ES

ACTOCORTINA 100 mg polvo y disolvente para solución inyectable

not available 28824 TAKEDA FARMACÉUTICA ESPAÑA S.A

ES

COLOFOAM, mousse rectale not available 3400932606122 MEDA PHARMA SAS FR Colifoam® Rektalschaum not available 2232.00.00 MEDA PHARMA GMBH & CO. KG DE Solu-Cortef 100 mg pulver og væske til injeksjonsvæske, oppløsning i tokammerhetteglass

not available 4532 PFIZER AS NO

Solu-Cortef 250 mg pulver og væske til injeksjonsvæske, oppløsning i tokammerhetteglass

not available 05-3196 PFIZER AS NO

Soventol Hydrocortisonacetat 0,5% 5 mg/g Creme

not available 88950.00.00 MEDICE PHARMA GMBH & CO. KG

DE

Locoid® scalp lotion, lotion 1 mg/ml not available MA024/01202 LEO PHARMA A/S MT

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List of nationally authorised medicinal products EMA/311363/2020 Page 16/26

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

Locoid® Lipocream, cream 1 mg/g not available MA024/01203 LEO PHARMA A/S MT Locoid® cream, cream 1 mg/g not available MA024/01205 LEO PHARMA A/S MT Locoid®, ointment 1 mg/g not available MA024/01204 LEO PHARMA A/S MT Locoid Crelo®, cutaneous emulsion 1 mg/g

not available MA024/01201 LEO PHARMA A/S MT

Alfason Cresa 0,1 % Creme not available 1614.00.00 LEO PHARMA A/S DE Alfason Creme 0,1 % Creme not available 4932.00.00 LEO PHARMA A/S DE Alfason Crelo 0,1 % Emulsion not available 6426259.00.00 LEO PHARMA A/S DE Alfason Salbe 0,1 % Salbe not available 26704.00.00 LEO PHARMA A/S DE Alfason Crinale 0,1 % Lösung zur Anwendung auf der Haut

not available 26704.00.01 LEO PHARMA A/S DE

Hydrocortisone Ointment 1% not available PL 06464/0699 WAYMADE PLC UK CORTEF 10 mg tablete not available HR-H-281556040 PFIZER CROATIA D.O.O. HR Dermacort Hydrocortisone Cream not available PL 23138/0007 MARLBOROUGH

PHARMACEUTICALS LTD UK

Hydrokortison Trimb 10 mg/g krem SE/H/0321/001 03-2320 TRIMB HEALTHCARE AB NO Hydrokortison ”Trimb”, creme SE/H/321/01 55525 TRIMB HEALTHCARE AB DK Hydrokortison Trimb 10 mg/g krem SE/H/321/01 IS/1/15/071/01 TRIMB HEALTHCARE AB IS Hydrokortison Trimb 10 mg/g kräm SE/H/321/01 11277 TRIMB HEALTHCARE AB SE SOLU-CORTEF 100 mg prašak i otapalo za otopinu za injekciju/infuziju

not available HR-H-226141869 PFIZER CROATIA D.O.O. HR

HIDROCORTISONA ROUSSEL 10 MG COMPRIMIDOS

not available 5558507 SANOFI - PRODUTOS FARMACEUTICOS LDA

PT

Locoid 1 mg/g krem. not available 761990 LEO PHARMA A/S IS Locoid Crelo 1 mg/g húðfleyti not available 920129 LEO PHARMA A/S IS Locoid 1 mg/g smyrsli. not available 761992 LEO PHARMA A/S IS Locoid 1 mg/g húðlausn. not available 761991 LEO PHARMA A/S IS

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List of nationally authorised medicinal products EMA/311363/2020 Page 17/26

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

Locoid Lipid 1 mg/g krem not available 843538 LEO PHARMA A/S IS Hydrocortisone 0.5% m/m Cream not available PL 00289/0753 TEVA UK LIMITED UK Hydrocortisone 1.0 % m/m Cream not available PL 00289/0754 TEVA UK LIMITED UK Hydrocortisone 2.5 % m/m Cream not available PL 00289/0755 TEVA UK LIMITED UK Solu-Cortef S.A.B. Act-O-Vial 500 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available 2005038741 PFIZER S.A. (BELGIUM) LU

Solu-Cortef S.A.B. Act-O-Vial 100 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available 2005038739 PFIZER S.A. (BELGIUM) LU

Solu-Cortef S.A.B. Act-O-Vial 250 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available 2005038740 PFIZER S.A. (BELGIUM) LU

Solu-Cortef S.A.B. Act-O-Vial 100 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available 2005038739 PFIZER S.A. (BELGIUM) LU

Solu-Cortef S.A.B. Act-O-Vial 250 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available 2005038740 PFIZER S.A. (BELGIUM) LU

Solu-Cortef S.A.B. Act-O-Vial 500 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available 2005038741 PFIZER S.A. (BELGIUM) LU

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List of nationally authorised medicinal products EMA/311363/2020 Page 18/26

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

Ficortril 1% salva not available 4969 PFIZER AB SE Ficortril 0,5% ögonsalva not available 4700 PFIZER AB SE Solu-Cortef S.A.B. Act-O-Vial 500 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available BE061476 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 500 mg Pulver zur Herstellung einer Injektionslösung

not available BE193295 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 100 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available BE061311 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 250 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung (S.A.B. = Sine Alcohol Benzylicus)

not available BE061451 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 100 mg Pulver zur Herstellung einer Injektionslösung

not available BE193277 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 500 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available BE061476 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 250 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available BE061451 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 100 mg Poudre pour solution injectable

not available BE193277 PFIZER S.A. (BELGIUM) BE

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List of nationally authorised medicinal products EMA/311363/2020 Page 19/26

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

Solu-Cortef S.A.B. Act-O-Vial 100 mg Poudre et solvant pour solution injectable (S.A.B. = Sine Alcohol Benzylicus)

not available BE061311 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 500 mg Poudre pour solution injectable

not available BE193295 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 500 mg Poeder en oplosmiddel voor oplossing voor injectie (S.A.B. = Sine Alcohol Benzylicus)

not available BE061476 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 100 mg Poeder en oplosmiddel voor oplossing voor injectie (S.A.B. = Sine Alcohol Benzylicus)

not available BE061311 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 500 mg Poeder voor oplossing voor injectie

not available BE193295 PFIZER S.A. (BELGIUM) BE

Solu-Cortef 100 mg Poeder voor oplossing voor injectie

not available BE193277 PFIZER S.A. (BELGIUM) BE

Solu-Cortef S.A.B. Act-O-Vial 250 mg Poeder en oplosmiddel voor oplossing voor injectie (S.A.B. = Sine Alcohol Benzylicus)

not available BE061451 PFIZER S.A. (BELGIUM) BE

HYDROCORTISONE UPJOHN 100 mg, préparation injectable

not available 34009 321 411 5 9 SERB FR

HYDROCORTISONE UPJOHN 100 mg, préparation injectable

not available 34009 321 412 1 0 SERB FR

HYDROCORTISONE UPJOHN 100 mg, préparation injectable

not available 337 312-1 SERB FR

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List of nationally authorised medicinal products EMA/311363/2020 Page 20/26

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

HYDROCORTISONE UPJOHN 100 mg, préparation injectable

not available 34009 337 313 8 0 SERB FR

HYDROCORTISONE 1.0% CREAM BP not available PL 0142/0609 ACTAVIS UK LIMITED UK Hydrocortison Hoechst® 100 mg pro Ampulle mit 20 ml Infusionslösungskonzentrat

not available 6196635.00.00 TEOFARMA S.R.L. DE

Hydrocortison Hoechst® 10 mg, Tabletten

not available 6196635.00.01 TEOFARMA S.R.L. DE

DERMOSA HIDROCORTISONA 1% not available 21428 TEOFARMA S.R.L. ES FeniHydrocort Creme 0,5 % not available 54735.01.00 GLAXOSMITHKLINE CONSUMER

HEALTHCARE GMBH & CO. KG DE

HYDROCORTISON TAKEDA 1 % -gel not available 13838 TAKEDA OY FI HYDROCORTISON TAKEDA 1 % -geeli not available 13838 TAKEDA OY FI Actocortina 500 mg polvo para solución inyectable

not available 52105 TAKEDA FARMACÉUTICA ESPAÑA S.A

ES

ACTOCORTINA 100 mg polvo y disolvente para solución inyectable

not available 28824 TAKEDA FARMACÉUTICA ESPAÑA S.A

ES

LENIRIT 0,5% Crema not available 025869013 EG S.P.A. IT Locoid oleogel, zalf 1 mg/g not available RVG 05909 LEO PHARMA A/S NL Locoid scalp lotion, lotion 1 mg/ml not available RVG 05910 LEO PHARMA A/S NL Locoid Crelo, emulsie voor cutaan gebruik 1 mg/g

not available RVG 16163 LEO PHARMA A/S NL

Locoid crème, crème 1 mg/g not available RVG 05911 LEO PHARMA A/S NL Locoid vetcrème, crème 1 mg/g not available RVG 09344 LEO PHARMA A/S NL Dioderm 0.1% w/w Cream not available PL 00173/0047 DIOMED DEVELOPMENTS

LIMITED UK

Ficortril® Augensalbe 0,5 % not available 6090078.00.00 DR. GERHARD MANN CHEM.- DE

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List of nationally authorised medicinal products EMA/311363/2020 Page 21/26

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

PHARM. FABRIK GMBH Hidrocisdin 5mg/g Crema not available 60.891 ISDIN, S.A. ES Nutrasona 1 mg/g crema not available 58.972 ISDIN, S.A. ES FLEBOCORTID RICHTER not available 013986029 SANOFI S.P.A IT FLEBOCORTID RICHTER not available 013986043 SANOFI S.P.A IT FLEBOCORTID RICHTER not available 013986031 SANOFI S.P.A IT Ebenol® 1 % Creme not available 57573.02.00 STRATHMANN GMBH & CO. KG DE Hydrocortisone 20mg Tablets not available PL 20075/1250 ACCORD HEALTHCARE LIMITED UK Hydrocortisone 10mg Tablets not available PL 20075/1249 ACCORD HEALTHCARE LIMITED UK Hydrocortone 20mg Tablets not available PL 20075/1250 ACCORD HEALTHCARE LIMITED UK Hydrocortisone Accord 20mg Tablets not available PL 20075/1250 ACCORD HEALTHCARE LIMITED UK Hitoden 20mg Tablets not available PL 20075/1250 ACCORD HEALTHCARE LIMITED UK Hydrocortone 10mg Tablets not available PL 20075/1249 ACCORD HEALTHCARE LIMITED UK Hydrocortisone Accord 10mg Tablets not available PL 20075/1249 ACCORD HEALTHCARE LIMITED UK Hitoden 10mg Tablets not available PL 20075/1249 ACCORD HEALTHCARE LIMITED UK Solu-Cortef 100 mg pulver och vätska till injektionsvätska, lösning

not available 2334 PFIZER OY FI

Solu-Cortef 250 mg pulver och vätska till injektionsvätska, lösning

not available 4405 PFIZER OY FI

Solu-Cortef 500 mg pulver och vätska till injektionsvätska, lösning

not available 4405 PFIZER OY FI

SOLU-CORTEF® 500 mg injektiokuiva-aine ja liuotin, liuosta varten

not available 4405 PFIZER OY FI

SOLU-CORTEF® 250 mg injektiokuiva-aine ja liuotin, liuosta varten

not available 4405 PFIZER OY FI

SOLU-CORTEF® 100 mg injektiokuiva-aine ja liuotin, liuosta varten

not available 2334 PFIZER OY FI

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List of nationally authorised medicinal products EMA/311363/2020 Page 22/26

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

Solu-Cortef Powder for Solution for Injection or Infusion 100 mg

not available PA 0822/137/001 PFIZER HEALTHCARE IRELAND IE

Solu-Cortef 100 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

not available H/93/01439/001 PFIZER LUXEMBOURG SARL SI

Solu-Cortef 500 mg prašek in vehikel za raztopino za injiciranje ali infundiranje

not available H/93/01439/002 PFIZER LUXEMBOURG SARL SI

HEMORRANE 10 mg/g pomada rectal not available 27941 FAES FARMA, S.A. ES Systral Hydrocort 0,5 % Creme not available 6421291.00.00 MEDA PHARMA GMBH & CO. KG DE COLIFOAM AER. 2 g / 20 g not available 1996043476 MEDA AB LU Mildison Lipid 1% krem not available 7602 KARO PHARMA AB NO Mildison Lipocream not available PL 50567/0002 KARO PHARMA AB UK SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container

IT/H/0413/001 PL 20162/0024 LABORATOIRES THEA UK

Softacort 3,35 mg/ml kapi za oko, otopina u jednodoznom spremniku

IT/H/0413/001 HR-H-079548102 LABORATOIRES THEA HR

Softacort 3,35 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis

IT/H/0413/001 137578 LABORATOIRES THEA AT

SOFTACORT 3,35 mg/ml colírio, solução em recipiente unidose

IT/H/0413/001 5711874 LABORATOIRES THEA PT

SOFTACORT 3,35 mg/ml picături oftalmice soluție în recipient unidoză

IT/H/0413/001 10015/2017/01 LABORATOIRES THEA RO

SOFTACORT 3,35 mg/ml picături oftalmice soluție în recipient unidoză

IT/H/0413/001 10015/2017/02 LABORATOIRES THEA RO

SOFTACORT 3,35 mg/ml picături oftalmice soluție în recipient unidoză

IT/H/0413/001 10015/2017/03 LABORATOIRES THEA RO

SOFTACORT 3,35 mg/ml picături oftalmice soluție în recipient unidoză

IT/H/0413/001 10015/2017/04 LABORATOIRES THEA RO

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List of nationally authorised medicinal products EMA/311363/2020 Page 23/26

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

СОФТАКОРТ 3,35 mg/ml капки за очи, разтвор в еднодозов контейнер

IT/H/0413/001 20170152 LABORATOIRES THEA BG

Softacort 3,35 mg/ml oční kapky, roztok v jednodávkovém obalu

IT/H/0413/001 64/480/14-C LABORATOIRES THEA CZ

Softacort, øjendråber, opløsning, enkeltdosisbeholder

IT/H/0413/001 55020 LABORATOIRES THEA DK

SOFTACORT 3,35 mg/ml, collyre en solution en récipient unidose

IT/H/0413/001 34009 300 956 1 4 LABORATOIRES THEA FR

SOFTACORT 3,35 mg/ml, collyre en solution en récipient unidose

IT/H/0413/001 34009 300 956 3 8 LABORATOIRES THEA FR

SOFTACORT 3,35 mg/ml, collyre en solution en récipient unidose

IT/H/0413/001 34009 300 956 4 5 LABORATOIRES THEA FR

SOFTACORT 3,35 mg/ml, collyre en solution en récipient unidose

IT/H/0413/001 34009 300 956 5 2 LABORATOIRES THEA FR

Softacort 3,35 mg/ml augndropar, lausn í stakskammtaíláti

IT/H/0413/001 IS/1/17/036/01 LABORATOIRES THEA IS

Softacort 3,35 mg/ml øyedråper, oppløsning i endosebeholder

IT/H/0413/001 14-10400 LABORATOIRES THEA NO

SOFTACORT, 3,35 mg/ml, krople do oczu, roztwór w pojemniku jednodawkowym

IT/H/0413/001 24253 LABORATOIRES THEA PL

Softacort 3,35 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku

IT/H/0413/001 H/17/02362/004 LABORATOIRES THEA SI

Softacort 3,35 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku

IT/H/0413/001 H/17/02362/001 LABORATOIRES THEA SI

Softacort 3,35 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku

IT/H/0413/001 H/17/02362/002 LABORATOIRES THEA SI

Softacort 3,35 mg/ml kapljice za oko, IT/H/0413/001 H/17/02362/003 LABORATOIRES THEA SI

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List of nationally authorised medicinal products EMA/311363/2020 Page 24/26

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

raztopina v enoodmernem vsebniku SOFTACORT 3,35 mg/ml οφθαλμικές σταγόνες, διάλυμα σε περιέκτη μίας δόσης

IT/H/0413/001 64103/31.08.2017 LABORATOIRES THEA GR

SOFTACORT 3,35 mg/ml očná roztoková instilácia v jednodávkovom obale

IT/H/0413/001 64/0213/17-S LABORATOIRES THEA SK

Softacor 3,35 mg/ml collyre en solution en récipient unidose

IT/H/0413/001 BE509173 LABORATOIRES THEA BE

Softacor 3,35 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik

IT/H/0413/001 BE509173 LABORATOIRES THEA BE

Softacor 3,35 mg/ml oogdruppels, oplossing in verpakking voor eenmalig gebruik

IT/H/0413/001 RVG 116462 LABORATOIRES THEA NL

Zoftacot 3.35 mg/ml eye drops, solution in single-dose container

IT/H/0413/001 PA 1107/13/1 LABORATOIRES THEA IE

Softacort 3,35 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis

IT/H/0413/001 93790.00.00 LABORATOIRES THEA DE

SOFACOR 3,35 mg/ml collirio, soluzione in contenitore monodose

IT/H/0413/001 044061012 LABORATOIRES THEA IT

SOFACOR 3,35 mg/ml collirio, soluzione in contenitore monodose

IT/H/0413/001 044061024 LABORATOIRES THEA IT

SOFACOR 3,35 mg/ml collirio, soluzione in contenitore monodose

IT/H/0413/001 044061036 LABORATOIRES THEA IT

SOFACOR 3,35 mg/ml collirio, soluzione in contenitore monodose

IT/H/0413/001 044061048 LABORATOIRES THEA IT

Softacort 3,35 mg/ml ögondroppar, IT/H/0413/001 52042 LABORATOIRES THEA 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

lösning i endosbehållare Softacort 3,35 mg/ml silmätipat, liuos, kerta-annospakkaus

IT/H/0413/001 32813 LABORATOIRES THEA FI

Softacort 3,35 mg/ml colirio en solución en envases unidosis

IT/H/0413/001 82398 LABORATOIRES THEA ES

SOFTACORT 3,35 mg/ml οφθαλμικές σταγόνες, διάλυμα σε περιέκτη μίας δόσης

IT/H/0413/001 022915 LABORATOIRES THEA CY

HYDROCORTISON Pfizer 100 mg sine Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung

not available 6177448.00.00 PFIZER PHARMA PFE GMBH DE

HYDROCORTISON Pfizer 250 mg sine Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung

not available 6177448.01.00 PFIZER PHARMA PFE GMBH DE

HYDROCORTISON Pfizer 500 mg sine Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung

not available 6177448.02.00 PFIZER PHARMA PFE GMBH DE

Solu-Cortef 100 mg not available PL 00057/1050 PFIZER LIMITED UK Hydrocortisone Acetate 25mg/ml Suspension for Injection

not available PL 20072/0221 AMDIPHARM UK LIMITED UK

Hydrocortistab Injection not available PL 20072/0221 AMDIPHARM UK LIMITED UK Calmiox Rectal 1 mg/g crema rectal not available 58.975 ESTEVE PHARMACEUTICALS,

S.A. ES

FeniHydrocort Creme 0,25%Hydrocortison 2,5 mg/g

not available 54735.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG

DE

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List of nationally authorised medicinal products EMA/311363/2020 Page 26/26

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

SOLU-CORTEF not available 3285780 LABORATÓRIOS PFIZER, LDA. PT SOLU-CORTEF not available 3285582 LABORATÓRIOS PFIZER, LDA. PT SOLU-CORTEF not available 3285889 LABORATÓRIOS PFIZER, LDA. PT SOLU-CORTEF not available 3285681 LABORATÓRIOS PFIZER, LDA. PT Ebenol® HCA 0,25% Creme mit Hydrocortisonacetat Zur Anwendung bei Erwachsenen und Kindern ab dem vollendeten 6. Lebensjahr

not available 6380623.00.00 STRATHMANN GMBH & CO. KG DE

Colifoam 10% w/w Rectal Foam not available PA2010/021/001 MYLAN IRE HEALTHCARE LIMITED

IE

Hydrocortisone 2.5 mg Muco-Adhesive Buccal Tablets Corlan® 2.5 mg Muco-Adhesive Buccal Tablets

not available PL 20075/0689 ACCORD HEALTHCARE LIMITED UK

SOLU-CORTEF not available 40397/07/19-5-2008 PFIZER HELLAS, A.E. GR SOLU-CORTEF not available 40395/07/19-5-2008 PFIZER HELLAS, A.E. GR