Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State /EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

60 mg

capsule, hard

oral use

Belgium

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

120 mg

capsule, hard

oral use

Belgium

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Belgium

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Belgium

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

60 mg

capsule, hard

oral use

Belgium

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

120 mg

capsule, hard

oral use

Bulgaria

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Bulgaria

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Bulgaria

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

60 mg

capsule, hard

oral use

Bulgaria

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

120 mg

capsule, hard

oral use

Czech Republic

Sandoz s.r.o

U Nákladového nádraží 10

CZ-130 00, Praha 3,

Czech Republic

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

Czech Republic

Sandoz s.r.o

U Nákladového nádraží 10

CZ-130 00, Praha 3,

Czech Republic

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

Czech Republic

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 60 mg

60 mg

capsule, hard

oral use

Czech Republic

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Denmark

Sandoz A/S,

Edvard Thomsens Vej 14,

DK-2300 Copenhagen S,

Denmark

Orlistat "Sandoz"

60 mg

capsule, hard

oral use

Denmark

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

60 mg

capsule, hard

oral use

Denmark

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

120 mg

capsule, hard

oral use

Estonia

Teva Pharma B.V

Computerweg 10

3542 DR Utrecht

The Netherlands

ORLISTAT TEVA 60 MG

60 mg

capsule, hard

oral use

Estonia

Teva Pharma B.V

Computerweg 10

3542 DR Utrecht

The Netherlands

ORLISTAT TEVA 120 MG

120 mg

capsule, hard

oral use

Estonia

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 60 MG

60 mg

capsule, hard

oral use

Estonia

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 120 MG

120 mg

capsule, hard

oral use

Estonia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 60 MG

60 mg

capsule, hard

oral use

Estonia

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 120 MG

120 mg

capsule, hard

oral use

Finland

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

120 mg

capsule, hard

oral use

Finland

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

60 mg

capsule, hard

oral use

Finland

Sandoz A/S

Edvard Thomsens Vej 14

S 2300 Copenhagen

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

Finland

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

120 mg

capsule, hard

oral use

Finland

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

60 mg

capsule, hard

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 120 mg, gélule

120 mg

capsule, hard

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 60 mg, gélule

60 mg

capsule, hard

oral use

France

EG LABO - Laboratoires EuroGenerics

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

ORLISTAT EG 120 mg, gélule

120 mg

capsule, hard

oral use

France

EG LABO - Laboratoires EuroGenerics

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

ORLISTAT EG 60 mg, gélule

60 mg

capsule, hard

oral use

France

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

ORLISTAT TEVA 120 mg, gélule

120 mg

capsule, hard

oral use

France

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

ORLISTAT TEVA 60 mg, gélule

60 mg

capsule, hard

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

Orlistat AL 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Germany

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 120 mg Hartkapseln

120 mg

capsule, hard

oral use

Germany

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 120 mg Hartkapseln

120 mg

capsule, hard

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Italy

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLSTAT EUROGENERICI

60 mg

capsule, hard

oral use

Italy

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLISTAT EG

120 mg

capsule, hard

oral use

Latvia

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

60 mg

capsule, hard

oral use

Latvia

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

120 mg

capsule, hard

oral use

Latvia

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Latvia

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Latvia

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

60 mg

capsule, hard

oral use

Latvia

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

capsule, hard

oral use

Lithuania

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

the Netherlands

Orlistat Teva

60 mg

capsule, hard

oral use

Lithuania

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

capsule, hard

oral use

Lithuania

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

120 mg

capsule, hard

oral use

Lithuania

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

60 mg

capsule, hard

oral use

Lithuania

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Lithuania

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Norway

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

60 mg

capsule, hard

oral use

Norway

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

120 mg

capsule, hard

oral use

Norway

Sandoz A/S,

Edvard Thomsens Vej 14,

2300 København S,

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

Poland

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 120 mg

120 mg

capsule, hard

oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

Poland

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 120 mg

120 mg

capsule, hard

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Poland

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 60 mg

60 mg

capsule, hard

oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

Poland

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 60 mg

60 mg

capsule, hard

oral use

Portugal

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Orlistato Ciclum

60 mg

capsule, hard

oral use

Portugal

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Orlistato Ciclum

120 mg

capsule, hard

oral use

Portugal

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

60 mg

capsule, hard

oral use

Portugal

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

120 mg

capsule, hard

oral use

Romania

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Sulixa

60 mg

capsule, hard

oral use

Romania

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Slovak Republic

TEVA Pharmaceuticals Slovakia s.r.o

Teslova 26

821 02 Bratislava

Slovak Republic

Orlistat Teva 60 mg

60 mg

capsule, hard

oral use

Slovak Republic

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Slovak Republic

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 60 mg

60 mg

capsule, hard

oral use

Slovak Republic

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 120 mg

120 mg

capsule, hard

oral use

Sweden

Sandoz A/S,, Edvard Thomsens Vej 14

DK-2300 Köpenhamn S,

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

United Kingdom

Teva UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG

United Kingdom

TEVA UK Orlistat capsules 60 mg

60 mg

capsule, hard

oral use

United Kingdom

Teva UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG

United Kingdom

TEVA UK Orlistat capsules 120 mg

120 mg

capsule, hard

oral use

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	Member State concerned	Date of notification
24.4.2012	Orlistat	See Annex I	See Annex I	26.4.2012