14 September 2016 EMA/706149/2016 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): botulinum toxin a - haemagglutinin complex Procedure No.: PSUSA/00000427/201512

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Product Name

MRP DCP Authorisation Number

National Authorisation Number

Azzalure

FR/H/0341/001

08-5655

MAH Name Institut Produits Synthèse (Ipsen) Ab

Azzalure

FR/H/0341/001

1544-01

Ipsen Biopharm Ltd

Cyprus

Azzalure

FR/H/0341/001

2-00357

Austria

Azzalure

FR/H/0341/001

24660

Azzalure

FR/H/0341/001

26541

Ipsen Biopharm Ltd Institut Produits Synthèse (Ipsen) Ab Institut Produits Synthèse (Ipsen) Ab

Azzalure

FR/H/0341/001

2905201

Ipsen Biopharm Ltd

Greece

Azzalure

FR/H/0341/001

39063019 & 39063021

Ipsen S.P.A.

Italy

Azzalure

FR/H/0341/001

393 419-2 & 393 420-0

France

Azzalure

FR/H/0341/001

42748

Ipsen Pharma Institut Produits Synthèse (Ipsen) Ab

Azzalure

FR/H/0341/001

5185640 & 5185657

Ipsen Developments Ltd

Portugal

Azzalure Azzalure 10 SPEYWOOD JEDNOTEK/0,05 ML

FR/H/0341/001

63/0115/10-S

Ipsen Biopharm Ltd

Slovakia

FR/H/0341/001

63/120/10-C

Ipsen Biopharm Ltd

Czech Republic

Azzalure

FR/H/0341/001

71.300

Ipsen Pharma Sa

Spain

Azzalure

FR/H/0341/001

72249.00.00

Ipsen Biopharm Ltd

Germany

Azzalure

FR/H/0341/001

BE 337653 & BE337653

Ipsen Biopharm Ltd

Belgium

Azzalure

FR/H/0341/001

BE337653

Ipsen Biopharm Ltd

Luxembourg

Azzalure

FR/H/0341/001

NR 16393

Ipsen Ltd

Poland

Azzalure

FR/H/0341/001

OGYI-T-21618/01 & OGYI-T-21618/02

Ipsen Biopharm Ltd

Hungary

Azzalure

FR/H/0341/001

PA 1609/1/1

Ipsen Biopharm Ltd

Ireland

Azzalure

FR/H/0341/001

PL 06958/0031

Ipsen Ltd

United Kingdom

Azzalure

FR/H/0341/001

RVG 106065

Netherlands

Azzalure

FR/H/0341/001

IS/1/09/023/01

Ipsen Biopharm Ltd Institut Produits Synthèse (Ipsen) Ab

Botulinum Toxin Type A Ipsen

PL 34926/0009 & PL 34926/0015

Ipsen Ltd

United Kingdom

Dysline

60806

Ipsen E.P.E.

Greece

List of nationally authorised medicinal products EMA/706149/2016

Authorisation country Norway

Finland Sweden

Denmark

Iceland

Page 2/4

National Authorisation Number

MAH Name

Authorisation country

Dysport

00-0352

Ipsen Ltd

Latvia

Dysport

028362034 & 028362046

Ipsen S.P.A.

Italy

Dysport

13-0226

Latvia

Dysport

13357

Dysport

14586

Ipsen Ltd Institut Produits Synthèse (Ipsen) Ab Institut Produits Synthèse (Ipsen) Ab

Dysport

2-00212

Ipsen Pharma Gmbh

Austria

Dysport

2002020015

Ipsen N.V.

Luxembourg

Dysport

21303

Poland

Dysport

2165884 & 3799483

Ipsen Ltd Ipsen Portugal Produtos Farmacêuticos, S.A.

Dysport

28362022

Italy

Dysport

28541

Ipsen S.P.A. Institut Produits Synthèse (Ipsen) Ab

Dysport

287399

Ipsen Ltd

Estonia

Dysport

34009 577 649 0 6 & 558 105-9

France

Dysport

43994

Dysport

46570

Ipsen Pharma Institut Produits Synthèse (Ipsen) Ab Institut Produits Synthèse (Ipsen) Ab

Dysport

50586.00.00 & 81122.00.00

Ipsen Pharma Gmbh

Germany

Dysport

61.155

Ipsen Pharma Sa

Spain

Dysport

63/0060/91-S

Ipsen Pharma

Slovakia

Dysport

63/0188/14-S

Ipsen Biopharm Ltd

Slovakia

Dysport 500 SPEYWOOD JEDNOTEK

63/060/91-S/C

Ipsen Biopharm Ltd

Czech Republic

Dysport 300 SPEYWOOD JEDNOTEK

63/335/12-C

Ipsen Biopharm Ltd

Czech Republic

Dysport 300 SPEYWOOD JEDNOTEK

65353 - 22/09/2011

Ipsen E.P.E.

Cyprus

Dysport

65353 – 22/09/2011

Ipsen E.P.E.

Greece

Product Name

MRP DCP Authorisation Number

List of nationally authorised medicinal products EMA/706149/2016

Finland Denmark

Portugal

Finland

Sweden Denmark

Page 3/4

National Authorisation Number

MAH Name

Authorisation country

Dysport

7334/2006/01

Ipsen Ltd

Romania

Dysport

75.790

Ipsen Pharma Sa

Spain

Dysport

807213

Ipsen Ltd

Estonia

Dysport

BE 180521

Ipsen N.V.

Belgium

Dysport

Ipsen Pharma

Slovenia

Dysport

H/02/00520/001 & H/02/00520/002 LT/1/99/0312/001 & LT/1/99/0312/002 & LT/1/99/0312/003 & LT/1/99/0312/004

Ipsen Ltd

Lithuania

Dysport

OGYI-T-8419/01 & OGYI-T-8419/02

Ipsen Pharma

Hungary

Dysport

OGYI-T-8419/03 & OGYI-T-8419/04

Ipsen Pharma

Hungary

Dysport

PA 1609/002/001

Ipsen Biopharm Ltd

Ireland

Dysport

PL 34926/0001 & PL 34926/0014

Ipsen Ltd

United Kingdom

Dysport

R/7292

Ipsen Ltd

Poland

Dysport

RVG 110868 & RVG 17505

Netherlands

Bulgaria

Product Name

MRP DCP Authorisation Number

Dysport

SE/H/0283/001

02-1442

Dysport

SE/H/0283/001

14099

Ipsen Farmaceutica B.V. Institut Produits Synthèse (Ipsen) Ab Institut Produits Synthèse (Ipsen) Ab

20030679 & 20140212

Ipsen Biopharm Ltd

диспорт

List of nationally authorised medicinal products EMA/706149/2016

Norway Sweden

Page 4/4

botulinum toxin a - European Medicines Agency - Europa EU

Sep 14, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ... EMA/706149/2016. Page 2/4. Product Name.

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