List of nationally authorised medicinal products
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1 30 May 2018 EMA/474010/2018 Human Medicines Evaluation Division Active substance: adapalene / benzoyl peroxide Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 National Number Epiduo 0,1% / 2,5% SE/H/0664/ GALDERMA NORDIC AB FI Epiduo 1 mg/g + 25 SE/H/0664/ LABORATORIOS GALDERMA PT Epiduo 1 mg/g + 25 SE/H/0664/ LABORATORIOS GALDERMA PT SE/H/0664/ GALDERMA BENELUX B.V. LU Epiduo 0,1 % / 2,5 % Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1%/2,5% γέλη SE/H/0664/ / GALDERMA HELLAS S.A. GR Epiduo, SE/H/0664/ GALDERMA NORDIC AB DK Epiduo 0,1% / 2,5% SE/H/0664/001 IS/1/09/084/01 GALDERMA NORDIC AB IS hlaup Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,1 % / 2,5 % SE/H/0664/ GALDERMA NORDIC AB NO Epiduo 0.1% / 2.5% SE/H/0664/001 PL 10590/0057 GALDERMA (UK) LIMITED UK Epiduo 0,1% / 2,5% SE/H/0664/ GALDERMA INTERNATIONAL AT EPIDUO 0,1%/2,5% SE/H/0664/001 BE GALDERMA BENELUX B.V. BE EPIDUO 0,1%/2,5% SE/H/0664/001 BE GALDERMA BENELUX B.V. BE EMA/474010/2018 Page 2/8
3 National Number EPIDUO 0,1% / 2,5% SE/H/0664/001 BE GALDERMA BENELUX B.V. BE EPIDUO 0,1% / 2,5% SE/H/0664/001 BE GALDERMA BENELUX B.V. BE Epiduo 0,1 % / 2,5 % SE/H/0664/001 BE GALDERMA BENELUX B.V. BE Epiduo 0,1% / 2,5% SE/H/0664/ GALDERMA LABORATORIUM DE GMBH Epiduo 0,1 % / 2,5 % SE/H/0664/001 BE GALDERMA BENELUX B.V. BE Epiduo 1 mg/g + 25 SE/H/0664/ LABORATORIOS GALDERMA ES SA EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR Epiduo 0,1 % / 2,5 % SE/H/0664/ GALDERMA NORDIC AB FI geeli EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR EPIDUO 0,1% / 2,5%, SE/H/0664/ OU GALDERMA INTERNATIONAL FR Epiduo 0,1% /2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 1 mg/g + 25 SE/H/0664/ LABORATORIOS GALDERMA PT EPIDUO 0,1%/2,5% SE/H/0664/ GALDERMA BENELUX B.V. LU Epiduo 0,1% / 2,5% SE/H/0664/ GALDERMA NORDIC AB SE Tactuo 0,1 % / 2,5% SE/H/0618/ GALDERMA NORDIC AB SE Tactuoben 1 mg/g + 25 SE/H/0618/ LABORATORIOS GALDERMA SA ES EMA/474010/2018 Page 3/8
4 National Number Epiduo 0,1% + 2,5% zel SE/H/0664/ GALDERMA POLSKA SP. Z PL O.O. Epiduo 1 mg/g + 25 SE/H/0664/ LABORATORIOS GALDERMA PT Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/001 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/002 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/003 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/004 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/005 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/006 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/007 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/008 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/009 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/001 LT/1/17/4074/010 GALDERMA INTERNATIONAL LT is Epiduo 1 mg/25 mg/g SE/H/0664/ GALDERMA INTERNATIONAL EE geel Epiduo 1 mg/g + 25 SE/H/0664/001 HR-H GALDERMA INTERNATIONAL HR Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/01 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/02 GALDERMA INTERNATIONAL RO EMA/474010/2018 Page 4/8
5 National Number Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/03 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/04 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/05 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/06 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/07 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/08 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/09 GALDERMA INTERNATIONAL RO Epiduo 1 mg/25 mg / g SE/H/0664/ /2017/10 GALDERMA INTERNATIONAL RO EPIDUO 0,1% I 2,5%, SE/H/0664/ GALDERMA INTERNATIONAL FR Epiduo 0.1 %/2.5% SE/H/0664/001 PA0590/030/001 GALDERMA (UK) LIMITED IE Epiduo 1 mg/25 mg/g SE/H/0664/ GALDERMA INTERNATIONAL LV s Epiduo 1 mg/g + 25 SE/H/0664/001 46/0114/17-S GALDERMA INTERNATIONAL SK Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/01 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/02 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/04 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/06 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/08 GALDERMA INTERNATIONAL HU EMA/474010/2018 Page 5/8
6 National Number Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/10 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/03 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/05 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/07 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 OGYI-T-23200/09 GALDERMA INTERNATIONAL HU Effezel 1 mg/g + 25 SE/H/0664/001 RVG GALDERMA BENELUX B.V. NL mg/g, Epiduo 0,1%/2,5% γέλη SE/H/0664/ GALDERMA HELLAS S.A. CY Епидуо 1 mg/ 25 mg/g SE/H/0664/ GALDERMA INTERNATIONAL BG гел Epiduo 0.1% / 2.5% SE/H/0664/001 MA 117/01202 GALDERMA INTERNATIONAL MT Epiduo 1 mg/g + 25 SE/H/0664/001 46/941/16-C GALDERMA INTERNATIONAL CZ Epiduo 0,3% / 2,5% SE/H/0664/002 IS/1/16/095/01 GALDERMA NORDIC AB IS hlaup Epiduo, 0,3 %/2,5 % SE/H/0664/ GALDERMA NORDIC AB DK Epiduo 0,3 % / 2,5 % SE/H/0664/ GALDERMA NORDIC AB NO Epiduo 0,3% / 2,5% SE/H/0664/ GALDERMA NORDIC AB SE Epiduo 0,3% / 2,5% SE/H/0664/ GALDERMA NORDIC AB FI geeli Epiduo 0,3% / 2,5% SE/H/0664/ GALDERMA NORDIC AB FI Epiduo 0.3% / 2.5% SE/H/0664/002 PL 10590/00067 GALDERMA (UK) LIMITED UK Epiduo 3 mg/g + 25 SE/H/0664/ LABORATORIOS GALDERMA PT Epiduo 3 mg/g + 25 SE/H/0664/ LABORATORIOS GALDERMA PT EMA/474010/2018 Page 6/8
7 National Number Epiduo Forte 0,3% / SE/H/0664/002 BE GALDERMA BENELUX B.V. BE 2,5% Epiduo Forte 0,3% / SE/H/0664/002 BE GALDERMA BENELUX B.V. BE 2,5% Epiduo Forte 0,3 % / 2,5 SE/H/0664/002 BE GALDERMA BENELUX B.V. BE % Epiduo 0,3%/2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo Forte 3 mg/g + SE/H/0664/ LABORATORIOS GALDERMA ES 25 SA Epiduo Forte, 0,3% + SE/H/0664/ GALDERMA POLSKA SP. Z PL 2,5%, zel O.O. Epiduo Forte 0,3% / SE/H/0664/002 BE GALDERMA BENELUX B.V. BE 2,5% Epiduo Forte 0,3% / SE/H/0664/002 BE GALDERMA BENELUX B.V. BE 2,5% Epiduo Forte 0,3 % / 2,5 SE/H/0664/002 BE GALDERMA BENELUX B.V. BE % Epiduo 0,3%/2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,3%/2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,3%/2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,3%/2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo 0,3%/2,5% SE/H/0664/ GALDERMA ITALIA S.P.A. IT Epiduo Forte SE/H/0664/ GALDERMA LABORATORIUM DE GMBH EPIDUO 0,3% / 2,5%, SE/H/0664/ GALDERMA INTERNATIONAL FR EPIDUO 0,3% / 2,5%, SE/H/0664/ GALDERMA INTERNATIONAL FR EPIDUO 0,3% / 2,5%, SE/H/0664/ GALDERMA INTERNATIONAL FR EPIDUO 0,3% / 2,5%, SE/H/0664/ GALDERMA INTERNATIONAL FR EPIDUO 0,3% / 2,5%, SE/H/0664/ GALDERMA INTERNATIONAL FR EMA/474010/2018 Page 7/8
8 National Number EPIDUO 0,3% / 2,5%, Epiduo Forte (0,3 + 2,5)% γέλη Epiduo Forte 0,3 % / 2,5 % Epiduo Forte 0,3% / 2,5% Epiduo Forte 0,3% / 2,5% SE/H/0664/ GALDERMA INTERNATIONAL FR SE/H/0664/ / GALDERMA HELLAS S.A. GR SE/H/0664/002 ON PACKAGING LEVEL GALDERMA BENELUX B.V. BE SE/H/0664/002 ON PACKAGING LEVEL GALDERMA BENELUX B.V. BE SE/H/0664/002 ON PACKAGING LEVEL GALDERMA BENELUX B.V. BE EMA/474010/2018 Page 8/8
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