Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. april 2012 do 30. april 2012

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES (1) ali člena 38 Direktive 2001/82/ES (2) )

DODATEK I

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

Država članica EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Belgija

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

60 mg

capsule, hard

oral use

Belgija

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

120 mg

capsule, hard

oral use

Belgija

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Belgija

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Belgija

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

60 mg

capsule, hard

oral use

Belgija

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

120 mg

capsule, hard

oral use

Bolgarija

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Bolgarija

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Bolgarija

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

60 mg

capsule, hard

oral use

Bolgarija

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

120 mg

capsule, hard

oral use

Češka

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

Češka

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

Češka

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 60 mg

60 mg

capsule, hard

oral use

Češka

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Danska

Sandoz A/S,

Edvard Thomsens Vej 14,

DK-2300 Copenhagen S,

Denmark

Orlistat "Sandoz"

60 mg

capsule, hard

oral use

Danska

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

60 mg

capsule, hard

oral use

Danska

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

120 mg

capsule, hard

oral use

Estonija

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

ORLISTAT TEVA 60 MG

60 mg

capsule, hard

oral use

Estonija

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

ORLISTAT TEVA 120 MG

120 mg

capsule, hard

oral use

Estonija

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 60 MG

60 mg

capsule, hard

oral use

Estonija

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 120 MG

120 mg

capsule, hard

oral use

Estonija

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 60 MG

60 mg

capsule, hard

oral use

Estonija

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 120 MG

120 mg

capsule, hard

oral use

Finska

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

120 mg

capsule, hard

oral use

Finska

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

60 mg

capsule, hard

oral use

Finska

Sandoz A/S

Edvard Thomsens Vej 14

S 2300 Copenhagen

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

Finska

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

120 mg

capsule, hard

oral use

Finska

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

60 mg

capsule, hard

oral use

Francija

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 120 mg, gélule

120 mg

capsule, hard

oral use

Francija

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 60 mg, gélule

60 mg

capsule, hard

oral use

Francija

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

Francija

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

Francija

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

Francija

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

Nemčija

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

Orlistat AL 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Nemčija

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 120 mg Hartkapseln

120 mg

capsule, hard

oral use

Nemčija

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Nemčija

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 120 mg Hartkapseln

120 mg

capsule, hard

oral use

Nemčija

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 60 mg Hartkapseln

60 mg

capsule, hard

oral use

Italija

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLSTAT EUROGENERICI

60 mg

capsule, hard

oral use

Italija

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLISTAT EG

120 mg

capsule, hard

oral use

Latvija

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

60 mg

capsule, hard

oral use

Latvija

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

120 mg

capsule, hard

oral use

Latvija

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Latvija

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Latvija

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

60 mg

capsule, hard

oral use

Latvija

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

capsule, hard

oral use

Litva

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

the Netherlands

Orlistat Teva

60 mg

capsule, hard

oral use

Litva

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

capsule, hard

oral use

Litva

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

120 mg

capsule, hard

oral use

Litva

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

60 mg

capsule, hard

oral use

Litva

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

capsule, hard

oral use

Litva

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Norveška

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

60 mg

capsule, hard

oral use

Norveška

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

120 mg

capsule, hard

oral use

Norveška

Sandoz A/S,

Edvard Thomsens Vej 14,

2300 København S,

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

Poljska

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 120 mg

120 mg

capsule, hard

oral use

Poljska

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

Poljska

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 120 mg

120 mg

capsule, hard

oral use

Poljska

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

Poljska

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 60 mg

60 mg

capsule, hard

oral use

Poljska

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

Poljska

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 60 mg

60 mg

capsule, hard

oral use

Portugalska

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

Portugalska

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

Portugalska

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

60 mg

capsule, hard

oral use

Portugalska

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

120 mg

capsule, hard

oral use

Romunija

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Sulixa

60 mg

capsule, hard

oral use

Romunija

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

capsule, hard

oral use

Slovaška

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

Orlistat Teva 60 mg

60 mg

capsule, hard

oral use

Slovaška

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

Orlistat Teva 120 mg

120 mg

capsule, hard

oral use

Slovaška

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 60 mg

60 mg

capsule, hard

oral use

Slovaška

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 120 mg

120 mg

capsule, hard

oral use

Švedska

Sandoz A/S,, Edvard Thomsens Vej 14

DK-2300 Köpenhamn S,

Denmark

Orlistat Sandoz

60 mg

capsule, hard

oral use

Nizozemska

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 60 mg

60 mg

capsule, hard

oral use

Nizozemska

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 120 mg

120 mg

capsule, hard

oral use

Velika Britanija

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

Velika Britanija

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

Datum sprejetja sklepa	Ime zdravila	Imetnik dovoljenja za promet	Zadevna država članica	Datum obvestila
24.4.2012	Orlistat	Glej Prilogo I	Glej Prilogo I	26.4.2012