# C_2012148EN.01001201.xml

| 25.5.2012 | EN | Official Journal of the European Union | C 148/12 |
| --- | --- | --- | --- |

25.5.2012

EN

Official Journal of the European Union

C 148/12

---

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)
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2012/C 148/02

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| 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 |

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

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 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 Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG

United Kingdom

TEVA UK Orlistat capsules 120 mg

120 mg

capsule, hard

oral use

---