12 April 2018 EMA/234056/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: clindamycin phosphate / tretinoin

Procedure no.: PSUSA/00010080/201707

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Acnatac 10mg/g + 0,25mg/g

SE/H/1134/001

85210.00.00

MEDA PHARMA GMBH & CO.

DE

Gel Acnatac 10 mg/g + 0,25 mg/g

KG SE/H/1134/001

74775/18-11-2014

SE/H/1134/001

15/202/13-C

MEDA PHARMA S.R.O.

CZ

SE/H/1134/001

29824

MEDA OY

FI

SE/H/1134/001

21435

MEDA PHARMA GMBH & CO.

PL

γέλη Acnatac 10 mg/g + 0,25 mg/g

MEDA PHARMACEUTICALS

GR

S.A.

gel Acnatac 10 mg/g + 0,25 mg/g geeli Acnatac , (10 mg + 0,25 mg)/g, żel

KG

Acnatac

SE/H/1134/01/DC

48954

MEDA AS

DK

Acnatac 10mg/g + 0,25mg/g gel

SE/H/1134/001

5585831

MEDA PHARMA – PRODUTOS

PT

FARMACÊUTICOS, S.A. Acnatac 10mg/g + 0,25mg/g gel

SE/H/1134/001

5585823

MEDA PHARMA – PRODUTOS

PT

FARMACÊUTICOS, S.A. Acnatac 10 mg/g + 0,25 mg/g

SE/H/1134/001

021888

γέλη Acnatac 10 mg/g + 0,25 mg/g

MEDA PHARMACEUTICALS

CY

S.A. SE/H/1134/001

46/0464/13-S

MEDA PHARMA SPOL. S R.O.

SK

Acnex 10mg/g+0,25mg/g gél

SE/H/1134/001

OGYI-T-22460/01

MEDA PHARMA HUNGARY

HU

ACNATAC 10 mg/g + 0,25

SE/H/1134/001

042056022

MEDA PHARMA S.P.A.

IT

SE/H/1134/001

46193

MEDA AB

SE

SE/H/1134/001

042056010

MEDA PHARMA S.P.A.

IT

SE/H/1134/001

812213

MEDA PHARMA SIA

EE

gél KFT. mg/g gel Acnatac 10 mg/g + 0,25 mg/g, gel ACNATAC 10 mg/g + 0,25 mg/g gel Treclinac 10 mg/0,25 mg/g geel

List of nationally authorised medicinal products EMA/234056/2018

Page 2/4

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Treclin 1 %/0.025 % w/w gel

SE/H/1134/001

MA806/01101

MEDA PHARMACEUTICALS

MT

LTD Treclin 1 %/0.025 % w/w gel

SE/H/1134/001

PL 15142/0249

MEDA PHARMACEUTICALS

UK

Treclinac 0,25 mg/g + 10 mg/g,

SE/H/1134/001

RVG 109745

MEDA PHARMA B.V.

NL

ZANEA 10 mg/0,25 mg, gel

SE/H/1134/001

34009 277 382 9 6

MEDA PHARMA SAS

FR

ZANEA 10 mg/0,25 mg, gel

SE/H/1134/001

34009 277 381 2 8

MEDA PHARMA SAS

FR

Treclinac 10 mg/ 0,25 mg/g gels

SE/H/1134/001

13-0090

MEDA PHARMA SIA

LV

Acnatac 10 mg/g + 0,25 mg/g

SE/H/1134/001

5669/2013/01

MEDA PHARMA GMBH & CO.

RO

LTD gel

gel

KG

Treclinac 10 mg/0,25 mg/g gelis

SE/H/1134/001

LT/1/13/3279/001

MEDA PHARMA SIA

LT

Acnatac 10 mg/g + 0,25 mg/g

SE/H/1134/001

1-31861

MEDA PHARMA GMBH

AT

SE/H/1134/001

PA1332/043/001

MEDA HEALTH SALES

IE

Gel Treclin 1 % / 0.025 % w/w Gel

IRELAND LIMITED Treclinax 10 mg/g + 0,25 mg/g

SE/H/1134/001

BE437507

S.A. MEDA PHARMA N.V.

BE

SE/H/1134/001

2013/110425

S.A. MEDA PHARMA N.V.

LU

SE/H/1134/001

BE437507

S.A. MEDA PHARMA N.V.

BE

Zalna 10 mg/g/0,25 mg/g gel

SE/H/1134/001

11-8356

MEDA AS

NO

Zalna 10 mg/0,25 mg v 1 g gel

SE/H/1134/001

H/13/01693/001

MEDA PHARMA GMBH & CO.

SI

Акнатак 10 mg/g + 0,25 mg/g

SE/H/1134/001/DC

20130224

MEDA PHARMA GMBH & CO.

SE/H/1134/001

IS/1/13/032/01

MEDA AB

gel Treclinax 10 mg/g + 0,25 mg/g gel Treclinax 10 mg/g + 0,25 mg/g gel

KG гел Acnatac 10mg/g +0,25mg/g

BG

KG IS

hlaup List of nationally authorised medicinal products EMA/234056/2018

Page 3/4

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Zalna 10 mg/0,25 mg v 1 g gel

SE/H/1134/001

H/13/01693/002

MEDA PHARMA GMBH & CO.

SI

KG Acnatac 10 mg/g + 0,25 mg/g

SE/H/1134/001

29824

MEDA OY

FI

SE/H/1134/001

BE437507

S.A. MEDA PHARMA N.V.

BE

SE/H/1134/001

2013/110425

S.A. MEDA PHARMA N.V.

LU

SE/H/1134/001

77.481

MEDA PHARMA S.L.

ES

SE/H/1134/001

5669/2013/02

MEDA PHARMA GMBH & CO.

RO

gel Treclinax 10 mg/g + 0,25 mg/g Gel Treclinax 10 mg/g + 0,25 mg/g Gel TRECLINAC 10 mg/g + 0,25 mg/g Gel* Acnatac 10 mg/g + 0,25 mg/g gel Acnex 10mg/g+0,25mg/g gél

KG SE/H/1134/001

OGYI-T-22460/02

MEDA PHARMA HUNGARY

HU

KFT.

List of nationally authorised medicinal products EMA/234056/2018

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