13 December 2017 EMA/36828/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: ivermectin (topical use)

Procedure no.: PSUSA/00010376/201704

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© European Medicines Agency, 2018. 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

Creme crème crème Crème крем κρέμα krém Creme

SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001

136170 BE 472657 BE 472657 BE 472657 20150192 022320 46/241/15-C 92429.00.00

AT BE BE BE BG CY CZ DE

Soolantra, creme Soolantra 10 mg/g kreem Soolantra 10 mg/g crema

SE/H/1428/001 SE/H/1428/001 SE/H/1428/001

54123 872915 79911

Soolantra 10 mg/g emulsiovoide Soolantra 10 mg/g emulsiovoide SOOLANTRA 10 mg/g, crème SOOLANTRA 10 mg/g, crème SOOLANTRA 10 mg/g, crème SOOLANTRA 10 mg/g, crème Soolantra 10 mg/g κρέμα Soolantra 10 mg/g krém Soolantra 10 mg/g krém Soolantra 10 mg/g krém Soolantra 10 mg/g krém Soolantra 10 mg/g krém Soolantra 10 mg/g cream Soolantra 10 mg/g krem Efacti 10 mg/g crema Efacti 10 mg/g crema

SE/H/1428/001

32238

GALDERMA INTERNATIONAL GALDERMA BENELUX B.V. GALDERMA BENELUX B.V. GALDERMA BENELUX B.V. GALDERMA INTERNATIONAL GALDERMA HELLAS S.A. GALDERMA INTERNATIONAL GALDERMA LABORATORIUM GMBH GALDERMA NORDIC AB GALDERMA INTERNATIONAL LABORATORIOS GALDERMA, S.A. GALDERMA NORDIC AB

SE/H/1428/001

32238

GALDERMA NORDIC AB

FI

SE/H/1428/001

34009 300 241 0 2

GALDERMA INTERNATIONAL

FR

SE/H/1428/001

34009 300 241 1 9

GALDERMA INTERNATIONAL

FR

SE/H/1428/001

34009 300 241 2 6

GALDERMA INTERNATIONAL

FR

SE/H/1428/001

34009 300 241 4 0

GALDERMA INTERNATIONAL

FR

SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001

45470/01.06.2016 OGYI-T-22822/01 OGYI-T-22822/02 OGYI-T-22822/03 OGYI-T-22822/04 OGYI-T-22822/05 PA 590/28/1 IS/1/15/048/01 043463013 043463025

GALDERMA GALDERMA GALDERMA GALDERMA GALDERMA GALDERMA GALDERMA GALDERMA GALDERMA GALDERMA

GR HU HU HU HU HU IE IS IT IT

Soolantra Soolantra Soolantra Soolantra Soolantra Soolantra Soolantra Soolantra

10 10 10 10 10 10 10 10

mg/g mg/g mg/g mg/g mg/g mg/g mg/g mg/g

List of nationally authorised medicinal products EMA/36828/2018

HELLAS S.A. INTERNATIONAL INTERNATIONAL INTERNATIONAL INTERNATIONAL INTERNATIONAL (UK) LIMITED NORDIC AB ITALIA S.P.A. ITALIA S.P.A.

DK EE ES 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

Efacti 10 mg/g crema Efacti 10 mg/g crema Efacti 10 mg/g crema Soolantra 10 mg/g kremas Soolantra 10 mg/g kremas Soolantra 10 mg/g kremas Soolantra 10 mg/g kremas Soolantra 10 mg/g kremas Soolantra 10 mg/g Creme Soolantra 10 mg/g crème Soolantra 10 mg/g krēms Soolantra 10 mg/g cream Soolantra 10 mg/g crème Soolantra 10 mg/g krem Soolantra 10 mg/g krem

SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001 SE/H/1428/001

043463037 043463049 043463052 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 2015070124 2015070124 15-0136 MA117/01101 RVG 115310 14-10067 22591

IT IT IT LT LT LT LT LT LU LU LV MT NL NO PL

Soolantra 10 mg/g creme

SE/H/1428/001

5645171

Soolantra Soolantra Soolantra Soolantra Soolantra Soolantra Soolantra Soolantra

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

7674/2015/01 7674/2015/02 7674/2015/03 7674/2015/04 7674/2015/05 51097 46/0218/15-S PL 10590/0063

GALDERMA ITALIA S.P.A. GALDERMA ITALIA S.P.A. GALDERMA ITALIA S.P.A. GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA BENELUX B.V. GALDERMA BENELUX B.V. GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA BENELUX B.V. GALDERMA NORDIC AB GALDERMA POLSKA SP. Z O.O. LABORATORIOS GALDERMA SA – SUCURSAL EM PORTUGAL GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA INTERNATIONAL GALDERMA NORDIC AB GALDERMA INTERNATIONAL GALDERMA (UK) LIMITED

10 10 10 10 10 10 10 10

mg/g mg/g mg/g mg/g mg/g mg/g mg/g mg/g

cremă cremă cremă cremă cremă kräm krém cream

List of nationally authorised medicinal products EMA/36828/2018

PT RO RO RO RO RO SE SK UK

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