1 December 2016 EMA/77613/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products Active substance: ivermectin (topical use) Procedure No.: PSUSA/00010376/201604

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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

Soolantra

SE/H/1428/001

136170

Galderma International

Austria

Soolantra

SE/H/1428/001

15-0136

Galderma International

Latvia

Soolantra

SE/H/1428/001

20150152

Galderma International

Bulgaria

Soolantra

SE/H/1428/001

Galderma Polska Sp. Z O.O.

Poland

Soolantra

SE/H/1428/001

22591 34009 300 241 0 2 & 34009 300 241 1 9 & 34009 300 241 2 6 & 34009 300 241 4 0

Galderma International

France

Soolantra

SE/H/1428/001

46/0218/15-S

Galderma International

Slovakia

Soolantra

SE/H/1428/001

46/241/15-C

Galderma International

Czech Republic

Soolantra

SE/H/1428/001

51097

Galderma Nordic Ab

Sweden

Soolantra

SE/H/1428/001

54123

Denmark

Soolantra

SE/H/1428/001

5645171

Galderma Nordic Ab Laboratorios Galderma Sa – Sucursal Em Portugal

Soolantra

SE/H/1428/001

79911

Laboratorios Galderma, S.A.

Spain

Soolantra

SE/H/1428/001

872915

Galderma International

Estonia

Soolantra

SE/H/1428/001

92429.00.00

Galderma Laboratorium Gmbh

Germany

Soolantra

SE/H/1428/001

Galderma Benelux B.V.

Belgium

Soolantra

SE/H/1428/001

BE 472657 LT/1/15/3726/001 & LT/1/15/3726/002 & LT/1/15/3726/003 & LT/1/15/3726/004 & LT/1/15/3726/005

Galderma International

Lithuania

Soolantra

SE/H/1428/001

Galderma International

Malta

Soolantra

SE/H/1428/001

MA117/01101 OGYI-T-22822/01 & OGYI-T22822/02 & OGYI-T22822/03 & OGYI-T22822/04 & OGYI-T22822/05

Galderma International

Hungary

Soolantra

SE/H/1428/001

PA 590/28/1

Galderma (Uk) Limited

Ireland

Soolantra

SE/H/1428/001

PL 10590/0063

Galderma (Uk) Limited

United Kingdom

Soolantra

SE/H/1428/001 SE/H/1428/001 & SE/H/1428/001/DC

RVG 115310

Galderma Benelux B.V.

Netherlands

32238

Galderma Nordic Ab

Finland

Soolantra List of nationally authorised medicinal products

Portugal

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

Soolantra

SE/H/1428/001/DC

Galderma Nordic Ab

Norway

Soolantra

SE/H/1428/001/DC

14-10067 7674/2015/01 & 7674/2015/02 & 7674/2015/03 & 7674/2015/04 & 7674/2015/05

Galderma International

Romania

Soolantra

SE/H/1428/001/DC

IS/1/15/048/01

Galderma Nordic Ab

Iceland

Soolantra

SE/H/1428/01/DC

GALDERMA HELIAS SA.

Cyprus

Soolantra

SE/H/1428/01/DC

GALDERMA HELIAS SA.

Greece

Soolantra

SE/H/1428/01/DC

Galderma Italia S.P.A.

Italy

List of nationally authorised medicinal products

ivermectin (topical use) - European Medicines Agency - Europa EU

Dec 1, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency, 2017. ... Product Name (in authorisation country).

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