# C_2008330EN.01001201.xml

| 30.12.2008 | EN | Official Journal of the European Union | C 330/12 |
| --- | --- | --- | --- |

30.12.2008

EN

Official Journal of the European Union

C 330/12

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2008 to 30 November 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

1

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

2

)

(2008/C 330/07)

—   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 |
| --- | --- | --- | --- | --- |
| 12.11.2008 | Lisonorm | See Annex I | See Annex I | 13.11.2008 |
| 14.11.2008 | Bromocriptine, dihydroergocryptine and lisuride | See Annex II | See Annex II | 18.11.2008 |
| 14.11.2008 | Cabergoline and pergolide | See Annex III | See Annex III | 18.11.2008 |
| 19.11.2008 | ZYPADHERA | Eli Lilly Nederland B.V. |
| Grootslag 1-5 |
| 3991 RA, Houten |
| Nederland |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

12.11.2008

Lisonorm

See Annex I

See Annex I

13.11.2008

14.11.2008

Bromocriptine, dihydroergocryptine and lisuride

See Annex II

See Annex II

18.11.2008

14.11.2008

Cabergoline and pergolide

See Annex III

See Annex III

18.11.2008

19.11.2008

ZYPADHERA

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA, Houten

Nederland

This Decision is addressed to the Member States

21.11.2008

19.11.2008

Norfloxacin

See Annex IV

See Annex IV

20.11.2008

28.11.2008

Efexor

See Annex V

See Annex V

2.12.2008

28.11.2008

Efexor Depot

See Annex VI

See Annex VI

2.12.2008

---

(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 FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Bulgaria | Gedeon Richter Plc. |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Bulgaria

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Dironorm

10 mg/5 mg

Tablets

Oral use

Czech Republic

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Lisonorm  (1)

10 mg/5 mg

Tablets

Oral use

Estonia

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Dironorm

10 mg/5 mg

Tablets

Oral use

Hungary

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Lisonorm

10 mg/5 mg

Tablets

Oral use

Latvia

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Dironorm

10 mg/5 mg

Tablets

Oral use

Lithuania

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Dironorm

10 mg/5 mg

Tablets

Oral use

Poland

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Dironorm

10 mg/5 mg

Tablets

Oral use

Romania

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Lisonorm 10mg/5mg

10 mg/5 mg

Tablets

Oral use

Slovak Republic

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Dironorm

10 mg/5 mg

Tablets

Oral use

---

(1)  Name approval pending.

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Bromocriptine containing medicinal products with Marketing Authorisation in the European Union

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Austria | MEDA PHARMA GmbH |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical Form

Route of Administration

Austria

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Parlodel 5 mg — Kapseln

5 mg

Capsule

Oral use

Austria

| MEDA PHARMA GmbH |
| --- |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Parlodel 2,5 mg — Kapseln

2,5 mg

Capsule

Oral use

Austria

| MEDA PHARMA GmbH |
| --- |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Parlodel SRO 10 mg — Kapseln

10 mg

Capsule

Oral use

Austria

| MEDA PHARMA GmbH |
| --- |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Parlodel SRO 2,5 mg — Kapseln

2,5 mg

Capsule

Oral use

Austria

| MEDA PHARMA GmbH |
| --- |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Parlodel SRO 5 mg — Kapseln

5 mg

Capsule

Oral use

Austria

| MEDA PHARMA GmbH |
| --- |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Umprel

10 mg

Capsule

Oral use

Austria

| MEDA PHARMA GmbH |
| --- |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Umprel

5 mg

Capsule

Oral use

Austria

| MEDA PHARMA GmbH |
| --- |
| Liesinger-Flur-Gasse 2c |
| A-1230 Wien |

MEDA PHARMA GmbH

Liesinger-Flur-Gasse 2c

A-1230 Wien

Umprel

2,5 mg

Capsule

Oral use

Belgium

| Meda Pharma S.A.-N.V. |
| --- |
| Chaussée de la Hulpe 166 |
| B-1170 Brussels |

Meda Pharma S.A.-N.V.

Chaussée de la Hulpe 166

B-1170 Brussels

Parlodel

2,5 mg

Tablet

Oral use

Belgium

| Meda Pharma S.A.-N.V. |
| --- |
| Chaussée de la Hulpe 166 |
| B-1170 Brussels |

Meda Pharma S.A.-N.V.

Chaussée de la Hulpe 166

B-1170 Brussels

Parlodel 10 MG

10 mg

Capsule, hard

Oral use

Belgium

| Meda Pharma S.A.-N.V. |
| --- |
| Chaussée de la Hulpe 166 |
| B-1170 Brussels |

Meda Pharma S.A.-N.V.

Chaussée de la Hulpe 166

B-1170 Brussels

Parlodel 5 mg

5 mg

Capsule, hard

Oral use

Bulgaria

| MEDOCHEMIE Limited |
| --- |
| 1-10 Constantinoupoleos Str. |
| Zakaki |
| CY-3505-Limassol |

MEDOCHEMIE Limited

1-10 Constantinoupoleos Str.

Zakaki

CY-3505-Limassol

Medocriptine

2,5 mg

Tablet

Oral use

Bulgaria

| NOVARTIS Pharma |
| --- |
| Square ‘Dzhon Paul II’ office centre ‘Bulgaria 2000’ |
| BG-1164 Sofia |

NOVARTIS Pharma

Square ‘Dzhon Paul II’ office centre ‘Bulgaria 2000’

BG-1164 Sofia

Parlodel

2,5 mg

Tablet

Oral use

Bulgaria

| SOPHARMA |
| --- |
| bul. ‘Kliment Ohridski’ No 3, Bulgaria |
| BG-1797 Sofia |

SOPHARMA

bul. ‘Kliment Ohridski’ No 3, Bulgaria

BG-1797 Sofia

Bromocriptine Sopharma

2,5 mg

Tablet

Oral use

Cyprus

| REMEDICA LTD |
| --- |
| P.O.Box 51706 |
| CY-3508 Lemesos |

REMEDICA LTD

P.O.Box 51706

CY-3508 Lemesos

Brameston

2,5 mg

Tablet

Oral use

Cyprus

| CODAL SYNTO LTD |
| --- |
| P.O.BOX 51785 |
| CY-3508 Lemesos |

CODAL SYNTO LTD

P.O.BOX 51785

CY-3508 Lemesos

Pirodal

2,5 mg

Tablet

Oral use

Cyprus

| DEMETRIADES & PAPAELLINAS Ltd |
| --- |
| P.O.Box 23490 |
| CY-1683 Lefkosia |

DEMETRIADES & PAPAELLINAS Ltd

P.O.Box 23490

CY-1683 Lefkosia

Parlodel

2,5 mg

Tablet

Oral use

Cyprus

| MEDOCHEMIE Limited |
| --- |
| 1-10 Constantinoupoleos Str. |
| Zakaki |
| CY-3505-Limassol |

MEDOCHEMIE Limited

1-10 Constantinoupoleos Str.

Zakaki

CY-3505-Limassol

Medocriptine

2,5 mg

Tablet

Oral use

Czech Republic

| MEDA PHARMA s. r. o. |
| --- |
| Záhřebská 577 |
| CZ-120 00 Praha 2 |

MEDA PHARMA s. r. o.

Záhřebská 577

CZ-120 00 Praha 2

Parlodel

2,87 mg

Tablet

Oral use

Czech Republic

| MEDOCHEMIE Limited |
| --- |
| 1-10 Constantinoupoleos Str. |
| Zakaki |
| CY-3505-Limassol |

MEDOCHEMIE Limited

1-10 Constantinoupoleos Str.

Zakaki

CY-3505-Limassol

Medocriptine

2,87 mg

Tablet

Oral use

Denmark

| MEDA AS |
| --- |
| Solvang 8 |
| DK-3450 Allerød |

MEDA AS

Solvang 8

DK-3450 Allerød

Parlodel

2,5 mg

Tablet

Oral use

Denmark

| MEDA AS |
| --- |
| Solvang 8 |
| DK-3450 Allerød |

MEDA AS

Solvang 8

DK-3450 Allerød

Parlodel

5 mg

Capsule, hard

Oral use

Denmark

| MEDA AS |
| --- |
| Solvang 8 |
| DK-3450 Allerød |

MEDA AS

Solvang 8

DK-3450 Allerød

Parlodel

10 mg

Capsule, hard

Oral use

Estonia

| GEDEON RICHTER |
| --- |
| Gyömröi út 19-21 |
| H-1103 Budapest |

GEDEON RICHTER

Gyömröi út 19-21

H-1103 Budapest

Promocriptin-Richter

2,5 mg

Tablet

Oral use

Estonia

| NOVARTIS Finland Oy |
| --- |
| Metsanneidonkuja 10 |
| FI-02130 Espoo |

NOVARTIS Finland Oy

Metsanneidonkuja 10

FI-02130 Espoo

Parlodel

2,5 mg

Tablet

Oral use

Finland

| MEDA Oy |
| --- |
| Lemminkäisenkatu 32 |
| FI-20520 Turku |

MEDA Oy

Lemminkäisenkatu 32

FI-20520 Turku

Parlodel

2,5 mg

Tablet

Oral use

Finland

| MEDA Oy |
| --- |
| Lemminkäisenkatu 32 |
| FI-20520 Turku |

MEDA Oy

Lemminkäisenkatu 32

FI-20520 Turku

Parlodel

10 mg

Capsule, hard

Oral use

Finland

| MEDA Oy |
| --- |
| Lemminkäisenkatu 32 |
| FI-20520 Turku |

MEDA Oy

Lemminkäisenkatu 32

FI-20520 Turku

Parlodel

5 mg

Capsule, hard

Oral use

Finland

| MEDA Oy |
| --- |
| Lemminkäisenkatu 32 |
| FI-20520 Turku |

MEDA Oy

Lemminkäisenkatu 32

FI-20520 Turku

Parlodel

10 mg

Capsule, hard

Oral use

Finland

| MEDA Oy |
| --- |
| Lemminkäisenkatu 32 |
| FI-20520 Turku |

MEDA Oy

Lemminkäisenkatu 32

FI-20520 Turku

Parlodel

5 mg

Capsule, hard

Oral use

France

| MEDA PHARMA |
| --- |
| 25, boulevard de l'Amiral Bruix |
| F-75016 Paris |

MEDA PHARMA

25, boulevard de l'Amiral Bruix

F-75016 Paris

Parlodel

5 mg

Capsule

Oral use

France

| MEDA PHARMA |
| --- |
| 25, boulevard de l'Amiral Bruix |
| F-75016 Paris |

MEDA PHARMA

25, boulevard de l'Amiral Bruix

F-75016 Paris

Parlodel

10 mg

Capsule

Oral use

France

| MEDA PHARMA |
| --- |
| 25, boulevard de l'Amiral Bruix |
| F-75016 Paris |

MEDA PHARMA

25, boulevard de l'Amiral Bruix

F-75016 Paris

Parlodel

2,5 mg

Scored tablet

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Bromocriptine

Winthrop

2,5 mg

Scored tablet

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Bromokin

2,5 mg

Scored tablet

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Parlodel

2,5 mg

Scored tablet

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Bromocriptine

Winthrop

5 mg

Capsule

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Bromocriptine

Winthrop

10 mg

Capsule

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Bromokin

5 mg

Capsule

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Bromokin

10 mg

Capsule

Oral use

France

| SANOFI-AVENTIS |
| --- |
| 1/13, boulevard Romain Rolland |
| F-75014 Paris |

SANOFI-AVENTIS

1/13, boulevard Romain Rolland

F-75014 Paris

Bromo-kin

2,5 mg

Tablet

Oral use

Germany

| MEDA PHARMA GmbH & Co. KG |
| --- |
| Benzstr. 1 |
| D-61352 Bad Homburg |

MEDA PHARMA GmbH & Co. KG

Benzstr. 1

D-61352 Bad Homburg

Pravidel 10 mg Kapseln

11,47 mg

Capsule, hard

Oral use

Germany

| MEDA PHARMA GmbH & Co. KG |
| --- |
| Benzstr. 1 |
| D-61352 Bad Homburg |

MEDA PHARMA GmbH & Co. KG

Benzstr. 1

D-61352 Bad Homburg

Pravidel 5 mg Kapseln

5,735 mg

Capsule, hard

Oral use

Germany

| MEDA PHARMA GmbH & Co. KG |
| --- |
| Benzstr. 1 |
| D-61352 Bad Homburg |

MEDA PHARMA GmbH & Co. KG

Benzstr. 1

D-61352 Bad Homburg

Pravidel 2,5 mg Tabletten

2,87 mg

Tablet

Oral use

Germany

| AbZ-PHARMA |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm, Germany |

AbZ-PHARMA

Graf-Arco-Str. 3

D-89079 Ulm, Germany

Bromocriptin AbZ 2,5mg Tabletten

2,87 mg

Tablet

Oral use

Germany

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Bromocriptin beta 5

5,735 mg

Capsule, hard

Oral use

Germany

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Bromocriptin beta 2,5

2,87 mg

Tablet

Oral use

Germany

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

bromocriptin-ct 5mg Hartkapseln

5,735 mg

Capsule, hard

Oral use

Germany

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

bromocriptin-ct 2,5 mg Tabletten

2,87 mg

Tablet

Oral use

Germany

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

bromocriptin-ct 10mg Hartkapseln

11,47 mg

Capsule, hard

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Bromocriptin Hexal 10 mg Kapseln

11,47 mg

Capsule, hard

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Kamilium 10 Kps.

11,47 mg

Capsule, hard

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Bromocriptin Hexal 5 mg Kapseln

5,735 mg

Capsule, hard

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Bromoxal 5 mg

5,735 mg

Capsule, hard

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Bromocriptin Hexal 5 mg Kapseln

5,735 mg

Capsule, hard

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Bromolakt 5 mg

5,735 mg

Capsule

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Bromoktin 5 mg

5,735 mg

Capsule

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Bromocriptin Hexal 2,5 mg Tabletten

2,87 mg

Tablet

Oral use

Germany

| HORMOSAN PHARMA GmbH |
| --- |
| Postfach 600340 |
| D-60333 Frankfurt |

HORMOSAN PHARMA GmbH

Postfach 600340

D-60333 Frankfurt

Kirim 5 T

5,74 mg

Tablet

Oral use

Germany

| HORMOSAN PHARMA GmbH |
| --- |
| Postfach 600340 |
| D-60333 Frankfurt |

HORMOSAN PHARMA GmbH

Postfach 600340

D-60333 Frankfurt

Kirim 2,5

2,87 mg

Tablet

Oral use

Germany

| TAURUS PHARMA GmbH |
| --- |
| Benzstr. 11 |
| D-61352 Bad Homburg |

TAURUS PHARMA GmbH

Benzstr. 11

D-61352 Bad Homburg

Kirim gyn

2,87 mg

Tablet

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Bromocriptin-ratiopharm 10mg Hartkapseln

11,47 mg

Capsule, hard

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Bromocriptin-ratiopharm 5mg Hartkapseln

5,735 mg

Capsule, hard

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Bromocriptin-ratiopharm 2,5mg Tabletten

2,87 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Bromocriptin Sandoz 10mg Hartkapseln

11,47 mg

Capsule, hard

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Bromocriptin Sandoz 5mg Hartkapseln

5,735 mg

Capsule, hard

Oral use

Greece

| MEDA PHARMACEUTICALS S.A. Greece |
| --- |
| 3 Evritanias Street |
| GR-15231 Halandri Attikis |

MEDA PHARMACEUTICALS S.A. Greece

3 Evritanias Street

GR-15231 Halandri Attikis

Parlodel

5 mg

Capsule, hard

Oral use

Greece

| MEDA PHARMACEUTICALS S.A. Greece |
| --- |
| 3 Evritanias Street |
| GR-15231 Halandri Attikis |

MEDA PHARMACEUTICALS S.A. Greece

3 Evritanias Street

GR-15231 Halandri Attikis

Parlodel

10 mg

Capsule, hard

Oral use

Hungary

| GEDEON RICHTER |
| --- |
| Gyömröi út 19-21 |
| H-1103 Budapest |

GEDEON RICHTER

Gyömröi út 19-21

H-1103 Budapest

Bromocriptine-Richter

2,5 mg

Tablet

Oral use

Iceland

| ICEPHARMA hf. |
| --- |
| Lynghálsi 13 |
| IS-110 Reykjavík |

ICEPHARMA hf.

Lynghálsi 13

IS-110 Reykjavík

Parlodel

5 mg

Capsule, hard

Oral use

Iceland

| ICEPHARMA hf. |
| --- |
| Lynghálsi 13 |
| IS-110 Reykjavík |

ICEPHARMA hf.

Lynghálsi 13

IS-110 Reykjavík

Parlodel

10 mg

Capsule, hard

Oral use

Iceland

| ICEPHARMA hf. |
| --- |
| Lynghálsi 13 |
| IS-110 Reykjavík |

ICEPHARMA hf.

Lynghálsi 13

IS-110 Reykjavík

Parlodel

2,5 mg

Tablet

Oral use

Ireland

| MEDA Health Sales Ireland Ltd |
| --- |
| Office 10 Dunboyne Business Park |
| Dunboyne, Co. Meath |
| Ireland |

MEDA Health Sales Ireland Ltd

Office 10 Dunboyne Business Park

Dunboyne, Co. Meath

Ireland

Parlodel

2,5 mg

Tablet

Oral use

Ireland

| MEDA Health Sales Ireland Ltd |
| --- |
| Office 10 Dunboyne Business Park |
| Dunboyne, Co. Meath |
| Ireland |

MEDA Health Sales Ireland Ltd

Office 10 Dunboyne Business Park

Dunboyne, Co. Meath

Ireland

Parlodel

5 mg

Capsule

Oral use

Italy

| MEDA PHARMA SpA |
| --- |
| Via Le Brenta, 18 |
| I-20139 Milano |

MEDA PHARMA SpA

Via Le Brenta, 18

I-20139 Milano

Parlodel

10 mg

Capsule

Oral use

Italy

| MEDA PHARMA SpA |
| --- |
| Via Le Brenta, 18 |
| I-20139 Milano |

MEDA PHARMA SpA

Via Le Brenta, 18

I-20139 Milano

Parlodel

5 mg

Capsule

Oral use

Italy

| DOROM Srl |
| --- |
| Via Giulio Richard 7 |
| I-20143 Milano |

DOROM Srl

Via Giulio Richard 7

I-20143 Milano

Bromocriptina Dorom

10 mg

Capsule

Oral use

Italy

| DOROM Srl |
| --- |
| Via Giulio Richard 7 |
| I-20143 Milano |

DOROM Srl

Via Giulio Richard 7

I-20143 Milano

Bromocriptina Dorom

5 mg

Capsule

Oral use

Latvia

| Lek farmacevtska drvžba d.d. |
| --- |
| Verovškova 57 |
| SLO-1000 Ljubljana |

Lek farmacevtska drvžba d.d.

Verovškova 57

SLO-1000 Ljubljana

Bromergon

2,5 mg

Tablet

Oral use

Latvia

| GEDEON RICHTER |
| --- |
| Gyömröi út 19-21 |
| H-1103 Budapest |

GEDEON RICHTER

Gyömröi út 19-21

H-1103 Budapest

Bromocriptin-Richter

2,5 mg

Tablet

Oral use

Latvia

| NOVARTIS Finland Oy |
| --- |
| Metsanneidonkuja 10 |
| FI-02130 Espoo |

NOVARTIS Finland Oy

Metsanneidonkuja 10

FI-02130 Espoo

Parlodel

2,5 mg

Tablet

Oral use

Lithuania

| GEDEON RICHTER |
| --- |
| Gyömröi út 19-21 |
| H-1103 Budapest |

GEDEON RICHTER

Gyömröi út 19-21

H-1103 Budapest

Bromocriptin-Richter

2,5 mg

Tablet

Oral use

Lithuania

| NOVARTIS Finland Oy |
| --- |
| Metsanneidonkuja 10 |
| FI-02130 Espoo |

NOVARTIS Finland Oy

Metsanneidonkuja 10

FI-02130 Espoo

Parlodel

2,5 mg

Tablet

Oral use

Lithuania

| POLI INDUSTRIA chimica S.p.A. |
| --- |
| Via Volturno 45/48-Quinto de Stampi |
| I-20089 Rozzano Milano |

POLI INDUSTRIA chimica S.p.A.

Via Volturno 45/48-Quinto de Stampi

I-20089 Rozzano Milano

Bromocriptine Poli

2,5 mg

Tablet

Oral use

Luxembourg

| MEDA PHARMA GmbH |
| --- |
| Benestraße 1 |
| D-61352 BAD Hamburg |

MEDA PHARMA GmbH

Benestraße 1

D-61352 BAD Hamburg

Pravidel

2,5 mg

Tablet

Oral use

Luxembourg

| MEDA PHARMA GmbH |
| --- |
| Benestraße 1 |
| D-61352 BAD Hamburg |

MEDA PHARMA GmbH

Benestraße 1

D-61352 BAD Hamburg

Pravidel

5 mg

Capsule

Oral use

Luxembourg

| MEDA PHARMA GmbH |
| --- |
| Benestraße 1 |
| D-61352 BAD Hamburg |

MEDA PHARMA GmbH

Benestraße 1

D-61352 BAD Hamburg

Pravidel

10 mg

Capsule

Oral use

Netherlands

| MEDA PHARMA B.V. |
| --- |
| Krijgsman 20 |
| 1186 DM AMSTELVEEN/NL |
| Nederland |

MEDA PHARMA B.V.

Krijgsman 20

1186 DM AMSTELVEEN/NL

Nederland

Parlodel 10 mg

10 mg

Capsule

Oral use

Netherlands

| MEDA PHARMA B.V. |
| --- |
| Krijgsman 20 |
| 1186 DM AMSTELVEEN/NL |
| Nederland |

MEDA PHARMA B.V.

Krijgsman 20

1186 DM AMSTELVEEN/NL

Nederland

Parlodel 2,5 mg

2,5 mg

Tablet

Oral use

Netherlands

| MEDA PHARMA B.V. |
| --- |
| Krijgsman 20 |
| 1186 DM AMSTELVEEN/NL |
| Nederland |

MEDA PHARMA B.V.

Krijgsman 20

1186 DM AMSTELVEEN/NL

Nederland

Parlodel 5 mg

5 mg

Tablet

Oral use

Poland

| Lek S.A. |
| --- |
| ul. Podlipie 16 |
| PL-95-010 Stryków |

Lek S.A.

ul. Podlipie 16

PL-95-010 Stryków

Bromergon

2,5 mg

Tablet

Oral use

Poland

| Filofarm |
| --- |
| Farmaceutyczna Spółdzielnia Pracy ‘Filofarm’ |
| ul. Pułaskiego 39 |
| PL-85-619 Bydgoszcz |

Filofarm

Farmaceutyczna Spółdzielnia Pracy ‘Filofarm’

ul. Pułaskiego 39

PL-85-619 Bydgoszcz

Bromocorn

2,87 mg

Tablet

Oral use

Poland

| Meda Aktiebolag |
| --- |
| Pipers vag 2 |
| P.O. Box 906 |
| S-170 09 Solana |

Meda Aktiebolag

Pipers vag 2

P.O. Box 906

S-170 09 Solana

Parlodel

2,5 mg

Tablet

Oral use

Poland

| POLFA |
| --- |
| Grodziskie Zakłady Farmaceutyczne POLFA Sp. z o.o. |
| ul. Poniatowskiego 5 |
| PL-05-825 Grodzisk Mazowiecki |

POLFA

Grodziskie Zakłady Farmaceutyczne POLFA Sp. z o.o.

ul. Poniatowskiego 5

PL-05-825 Grodzisk Mazowiecki

Ergolaktyna

2,5 mg

Tablet

Oral use

Portugal

| MEDA PHARMA — Produtos Farmacêuticos, SA |
| --- |
| Rua do Centro Cultural, 13 |
| P-1749-066 Lisboa |

MEDA PHARMA — Produtos Farmacêuticos, SA

Rua do Centro Cultural, 13

P-1749-066 Lisboa

Parlodel

2,5 mg

Tablet

Oral use

Portugal

| MEDA PHARMA — Produtos Farmacêuticos, SA |
| --- |
| Rua do Centro Cultural, 13 |
| P-1749-066 Lisboa |

MEDA PHARMA — Produtos Farmacêuticos, SA

Rua do Centro Cultural, 13

P-1749-066 Lisboa

Parlodel

5 mg

Capsule

Oral use

Portugal

| MEDA PHARMA — Produtos Farmacêuticos, SA |
| --- |
| Rua do Centro Cultural, 13 |
| P-1749-066 Lisboa |

MEDA PHARMA — Produtos Farmacêuticos, SA

Rua do Centro Cultural, 13

P-1749-066 Lisboa

Parlodel

10 mg

Capsule

Oral use

Portugal

| Generis Farmacêutica, SA |
| --- |
| Office Park da Beloura |
| Edifício 4 |
| Quinta da Beloura |
| P-2710-444 Sintra |

Generis Farmacêutica, SA

Office Park da Beloura

Edifício 4

Quinta da Beloura

P-2710-444 Sintra

Bromocriptina Generis 2,5 mg comprimidos

2,5 mg

Tablet

Oral use

Romania

| S.C. BIOFARM S.A. |
| --- |
| Str. Logofat Tautu nr. 99, sector 3 |
| București, România |

S.C. BIOFARM S.A.

Str. Logofat Tautu nr. 99, sector 3

București, România

Brocriptin

2,5mg

Tablet

Oral use

Slovak Republic

| MEDA PHARMA s. r. o. |
| --- |
| Záhřebská 577 |
| CZ-120 00 Praha 2 |

MEDA PHARMA s. r. o.

Záhřebská 577

CZ-120 00 Praha 2

Parlodel

2,5 mg

Tablet

Oral use

Slovak Republic

| MEDOCHEMIE Limited |
| --- |
| 1-10 Constantinoupoleos Str. |
| Zakaki |
| CY-3505-Limassol |

MEDOCHEMIE Limited

1-10 Constantinoupoleos Str.

Zakaki

CY-3505-Limassol

Medocriptine 2,5 mg

2,5 mg

Tablet

Oral use

Slovenia

| Lek farmacevtska družba d.d. |
| --- |
| Verovškova 57 |
| SLO-1000 Ljubljana |

Lek farmacevtska družba d.d.

Verovškova 57

SLO-1000 Ljubljana

Bromergon

2,5 mg

Tablet

Oral use

Spain

| MEDA PHARMA SAU |
| --- |
| Avda Castilla, 2 |
| Edif Berlin 2a planta, parque empresarial |
| E-28830 San Fernando de Henares |

MEDA PHARMA SAU

Avda Castilla, 2

Edif Berlin 2a planta, parque empresarial

E-28830 San Fernando de Henares

Parlodel 2,5 mg comprimidos

2,5 mg

Tablet

Oral use

Spain

| MEDA PHARMA SAU |
| --- |
| Avda Castilla, 2 |
| Edif Berlin 2a planta, parque empresarial |
| E-28830 San Fernando de Henares |

MEDA PHARMA SAU

Avda Castilla, 2

Edif Berlin 2a planta, parque empresarial

E-28830 San Fernando de Henares

Parlodel 5 mg capsulas

5 mg

Capsule

Oral use

Sweden

| MEDA AB |
| --- |
| Box 906 |
| S-170 09 Solna |

MEDA AB

Box 906

S-170 09 Solna

Pravidel

2,5 mg

Tablet

Oral use

Sweden

| MEDA AB |
| --- |
| Box 906 |
| S-170 09 Solna |

MEDA AB

Box 906

S-170 09 Solna

Pravidel

5 mg

Capsule, hard

Oral use

Sweden

| MEDA AB |
| --- |
| Box 906 |
| S-170 09 Solna |

MEDA AB

Box 906

S-170 09 Solna

Pravidel

10 mg

Capsule, hard

Oral use

United Kingdom

| MEDA Pharmaceuticals Limited |
| --- |
| Building 2000 |
| Beach Drive |
| Cambridge Research Park |
| Waterbeach |
| Cambridgeshire CB5 9PD |
| United Kingdom |

MEDA Pharmaceuticals Limited

Building 2000

Beach Drive

Cambridge Research Park

Waterbeach

Cambridgeshire CB5 9PD

United Kingdom

Parlodel 2,5 mg tablets

5 mg

Tablet

Oral use

United Kingdom

| MEDA Pharmaceuticals Limited |
| --- |
| Building 2000 |
| Beach Drive |
| Cambridge Research Park |
| Waterbeach |
| Cambridgeshire CB5 9PD |
| United Kingdom |

MEDA Pharmaceuticals Limited

Building 2000

Beach Drive

Cambridge Research Park

Waterbeach

Cambridgeshire CB5 9PD

United Kingdom

Parlodel 2,5 mg tablets

10 mg

Tablet

Oral use

United Kingdom

| MEDA Pharmaceuticals Limited |
| --- |
| Building 2000 |
| Beach Drive |
| Cambridge Research Park |
| Waterbeach |
| Cambridgeshire CB5 9PD |
| United Kingdom |

MEDA Pharmaceuticals Limited

Building 2000

Beach Drive

Cambridge Research Park

Waterbeach

Cambridgeshire CB5 9PD

United Kingdom

Parlodel 2,5 mg tablets

2,5 mg

Tablet

Oral use

United Kingdom

| MEDA Pharmaceuticals Limited |
| --- |
| Building 2000 |
| Beach Drive |
| Cambridge Research Park |
| Waterbeach |
| Cambridgeshire CB5 9PD |
| United Kingdom |

MEDA Pharmaceuticals Limited

Building 2000

Beach Drive

Cambridge Research Park

Waterbeach

Cambridgeshire CB5 9PD

United Kingdom

Parlodel 1 mg tablets

1 mg

Tablet

Oral use

United Kingdom

| NORTON Healthcare Limited |
| --- |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

NORTON Healthcare Limited

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Bromocriptine tablets BP 2,5 mg

2,5 mg

Tablet

Oral use

United Kingdom

| GENERICS (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Herts EN6 1TL |
| United Kingdom |

GENERICS (UK) Limited

Station Close

Potters Bar

Herts EN6 1TL

United Kingdom

Bromocriptine tablets BP 2,5 mg

2,5 mg

Tablet

Oral use

United Kingdom

| NOVARTIS Pharmaceuticals UK Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey GU16 7SR |
| United Kingdom |

NOVARTIS Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Parlodel LAR injection 50 mg

50 mg

Powder for injection

Intramuscular use

United Kingdom

| NOVARTIS Pharmaceuticals UK Limited |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey GU16 7SR |
| United Kingdom |

NOVARTIS Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Parlodel LAR injection 100 mg

100 mg

Powder for injection

Intramuscular use

Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Defiante Farmaceutica Lda. |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical Form

Route of administration

Austria

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin — Fas 4,5 mg — Filmtabletten

4,5 mg

Tablet

Oral use

Austria

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin 1 mg/ml — Tropfen

1 mg/ml

Oral drops

Oral use

Austria

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin 3 mg/ml — Tropfen

3 mg/ml

Oral drops

Oral use

Austria

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin 1 mg — Tabletten

1 mg

Tablet

Oral use

Austria

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin 2 mg — Tabletten

2 mg

Tablet

Oral use

Austria

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin 0,3 mg/1 ml — Ampullen

0,3 mg/1 m

Solution for injection

Intravenous use

Austria

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin SRO 6 mg — Kapseln

6 mg

Capsule

Oral use

Austria

| RATIOPHARM Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| A-1140 Wien |

RATIOPHARM Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Co-Dergocrin ‘ratiopharm’ retard 5 mg — Kapseln

5 mg

Capsule

Oral use

Austria

| RATIOPHARM Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| A-1140 Wien |

RATIOPHARM Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Co-Dergocrin ‘ratiopharm’ retard 2,5 mg — Kapseln

2,5 mg

Capsule

Oral use

Austria

| SANOVA Pharma GmbH |
| --- |
| Haidestraße 4 |
| A-1110 Wien |

SANOVA Pharma GmbH

Haidestraße 4

A-1110 Wien

Dorehydrin 1 mg/ml — Tropfen

1 mg/ml

Oral drops

Oral use

Austria

| SANOVA Pharma GmbH |
| --- |
| Haidestraße 4 |
| A-1110 Wien |

SANOVA Pharma GmbH

Haidestraße 4

A-1110 Wien

Dorehydrin retard 2,5 mg — Kapseln

2,5 mg

Capsule

Oral use

Austria

| SANOVA Pharma GmbH |
| --- |
| Haidestraße 4 |
| A-1110 Wien |

SANOVA Pharma GmbH

Haidestraße 4

A-1110 Wien

Dorehydrin retard 4,5 mg — Kapseln

4,5 mg

Capsule

Oral use

Austria

| WABOSAN Arzneimittelvertriebs GmbH |
| --- |
| Anton Anderer Platz 6/1 |
| A-1210 Wien |

WABOSAN Arzneimittelvertriebs GmbH

Anton Anderer Platz 6/1

A-1210 Wien

Ergomed retard- Kapseln

0,875 mg

Capsule

Oral use

Austria

| WABOSAN Arzneimittelvertriebs GmbH |
| --- |
| Anton Anderer Platz 6/1 |
| A-1210 Wien |

WABOSAN Arzneimittelvertriebs GmbH

Anton Anderer Platz 6/1

A-1210 Wien

Ergomed — Tabletten

0,33 mg

Tablet

Oral use

Austria

| WABOSAN Arzneimittelvertriebs GmbH |
| --- |
| Anton Anderer Platz 6/1 |
| A-1210 Wien |

WABOSAN Arzneimittelvertriebs GmbH

Anton Anderer Platz 6/1

A-1210 Wien

Ergomed — Tropfen

0,33 mg/ml

Oral drops

Oral use

Belgium

| NOVARTIS PHARMA nv. |
| --- |
| Medialaan 40 |
| B-1800 Vilvoorde |

NOVARTIS PHARMA nv.

Medialaan 40

B-1800 Vilvoorde

Hydergine

1 mg/ml

Oral drops, solution

Oral use

Belgium

| NOVARTIS PHARMA nv. |
| --- |
| Medialaan 40 |
| B-1800 Vilvoorde |

NOVARTIS PHARMA nv.

Medialaan 40

B-1800 Vilvoorde

Hydergine 1,5 mg

1,5 mg

Tablet

Oral use

Belgium

| NOVARTIS PHARMA nv. |
| --- |
| Medialaan 40 |
| B-1800 Vilvoorde |

NOVARTIS PHARMA nv.

Medialaan 40

B-1800 Vilvoorde

Hydergine 4,5 mg

4,5 mg

Tablet

Oral use

Belgium

| NOVARTIS PHARMA nv. |
| --- |
| Medialaan 40 |
| B-1800 Vilvoorde |

NOVARTIS PHARMA nv.

Medialaan 40

B-1800 Vilvoorde

Hydergine FAS 4,5 mg

4,5 mg

Gastro-resistant tablet

Oral use

Belgium

| LABORATOIRES PHARMACOBEL |
| --- |
| Avenue de Seheut, 46-50 |
| B-1070 Bruxelles |

LABORATOIRES PHARMACOBEL

Avenue de Seheut, 46-50

B-1070 Bruxelles

Dystonal 2,5 mg (N.F.)

2,5 mg

Tablet

Oral use

Belgium

| NYCOMED BELGIUM |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

NYCOMED BELGIUM

Gentsesteenweg 615

B-1080 Brussel

Stofilan

1,5 mg

Tablet

Oral use

Belgium

| NYCOMED BELGIUM |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

NYCOMED BELGIUM

Gentsesteenweg 615

B-1080 Brussel

Stofilan

1 mg/ml

Oral solution

Oral use

Belgium

| NYCOMED BELGIUM |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

NYCOMED BELGIUM

Gentsesteenweg 615

B-1080 Brussel

Stofilan

4,5 mg

Tablet

Oral use

Belgium

| SANDIPRO s.a. |
| --- |
| Chaussée de Gand, 615 |
| B-1080 Bruxelles |

SANDIPRO s.a.

Chaussée de Gand, 615

B-1080 Bruxelles

IBEXONE 1,5 mg

1,5 mg

Tablet

Oral use

Belgium

| SANDIPRO s.a. |
| --- |
| Chaussée de Gand, 615 |
| B-1080 Bruxelles |

SANDIPRO s.a.

Chaussée de Gand, 615

B-1080 Bruxelles

IBEXONE

1 mg/ml

Oral solution

Oral use

Belgium

| SANDIPRO s.a. |
| --- |
| Chaussée de Gand, 615 |
| B-1080 Bruxelles |

SANDIPRO s.a.

Chaussée de Gand, 615

B-1080 Bruxelles

IBEXONE 4,5 mg

4,5 mg

Tablet

Oral use

Belgium

| SANDIPRO s.a. |
| --- |
| Chaussée de Gand, 615 |
| B-1080 Bruxelles |

SANDIPRO s.a.

Chaussée de Gand, 615

B-1080 Bruxelles

IBEXONE

3 mg/ml

Oral solution

Oral use

Bulgaria

| POLI INDUSTRIA chimica S.p.A. |
| --- |
| Via Volturno 45/48-Quinto de Stampi |
| I-20089 Rozzano Milano |

POLI INDUSTRIA chimica S.p.A.

Via Volturno 45/48-Quinto de Stampi

I-20089 Rozzano Milano

Almirid 5

5 mg

Capsule, hard

Oral use

Bulgaria

| POLI INDUSTRIA chimica S.p.A. |
| --- |
| Via Volturno 45/48-Quinto de Stampi |
| I-20089 Rozzano Milano |

POLI INDUSTRIA chimica S.p.A.

Via Volturno 45/48-Quinto de Stampi

I-20089 Rozzano Milano

Almirid 5

20 mg

Tablet

Oral use

Czech Republic

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

20 mg

Tablet

Oral use

Czech Republic

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

5 mg

Capsule, hard

Oral use

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Hydergin

1mg

Tablet

Oral use

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Hydergin

1,5mg

Tablet

Oral use

France

| Novartis Pharma SAS |
| --- |
| 2 & 4 Rue Lionel Terray |
| F-92506 Rueil Malmaison Cedex |

Novartis Pharma SAS

2 & 4 Rue Lionel Terray

F-92506 Rueil Malmaison Cedex

Hydergine

0,3 mg/1 ml

Solution for injection

Oral use

France

| Novartis Pharma SAS |
| --- |
| 2 & 4 Rue Lionel Terray |
| F-92506 Rueil Malmaison Cedex |

Novartis Pharma SAS

2 & 4 Rue Lionel Terray

F-92506 Rueil Malmaison Cedex

Hydergine

1 mg/1 ml

Oral solution

Oral use

France

| Novartis Pharma SAS |
| --- |
| 2 & 4 Rue Lionel Terray |
| F-92506 Rueil Malmaison Cedex |

Novartis Pharma SAS

2 & 4 Rue Lionel Terray

F-92506 Rueil Malmaison Cedex

Hydergine

4,5 mg

Tablet

Oral use

Germany

| DESITIN Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg, Germany |

DESITIN Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg, Germany

Almirid

20 mg

Tablet

Oral use

Germany

| DESITIN Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |

DESITIN Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Almirid

40 mg

Tablet

Oral use

Germany

| DESITIN Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |

DESITIN Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Almirid

5 mg

Capsule

Oral use

Germany

| TAURUS PHARMA GmbH |
| --- |
| Benzstr. 11 |
| D-61352 Bad Homburg |

TAURUS PHARMA GmbH

Benzstr. 11

D-61352 Bad Homburg

Cripar 20

20 mg

Tablet

Oral use

Germany

| TAURUS PHARMA GmbH |
| --- |
| Benzstr. 11 |
| D-61352 Bad Homburg |

TAURUS PHARMA GmbH

Benzstr. 11

D-61352 Bad Homburg

Cripar forte 40

40 mg

Tablet

Oral use

Germany

| TAURUS PHARMA GmbH |
| --- |
| Benzstr. 11 |
| D-61352 Bad Homburg, Germany |

TAURUS PHARMA GmbH

Benzstr. 11

D-61352 Bad Homburg, Germany

Cripar 5

5 mg

Capsule

Oral use

Germany

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin 1 mg/ml Tropflösung

0,333 mg

Oral drops, solution

Oral use

Germany

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin forte 2 mg Tabletten

0,666 mg

Tablet

Oral use

Germany

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin forte 2 mg/ml Tropflösung

0,67 mg

Oral drops, solution

Oral use

Germany

| Defiante Farmaceutica Lda. |
| --- |
| Rua dos Ferreiros 260 |
| P-9000-082 Funchal/Madeira |

Defiante Farmaceutica Lda.

Rua dos Ferreiros 260

P-9000-082 Funchal/Madeira

Hydergin Spezial

1,33 mg

Film-coated tablet

Oral use

Germany

| DESITIN Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |

DESITIN Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Ergodesit forte 2 mg

0,66 mg

Tablet

Oral use

Germany

| DESITIN Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |

DESITIN Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Ergodesit spezial 5 mg

1,66 mg

Prolonged-release tablet

Oral use

Germany

| OPFERMANN Arzneimittel GmbH |
| --- |
| Robert-Koch-Str. 2 |
| D-51674 Wiehl |

OPFERMANN Arzneimittel GmbH

Robert-Koch-Str. 2

D-51674 Wiehl

Orphol forte 3 mg/ml

1 mg

Oral solution

Oral use

Germany

| OPFERMANN Arzneimittel GmbH |
| --- |
| Robert-Koch-Str. 2 |
| D-51674 Wiehl |

OPFERMANN Arzneimittel GmbH

Robert-Koch-Str. 2

D-51674 Wiehl

Orphol Spezial

1,5 mg

Tablet

Oral use

Germany

| OPFERMANN Arzneimittel GmbH |
| --- |
| Robert-Koch-Str. 2 |
| D-51674 Wiehl |

OPFERMANN Arzneimittel GmbH

Robert-Koch-Str. 2

D-51674 Wiehl

Orphol Brausetabletten

1,5 mg

Effervescent tablet

Oral use

Germany

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DCCK Tropflösung

1 mg

Prolonged-release capsule, hard

Oral use

Germany

| Amdipharm Limited |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DCCK Depot 4,5

1,5 mg

Prolonged-release capsule, hard

Oral use

Germany

| FARMASAN Arzneimittel GmbH & Co.KG |
| --- |
| Postfach 410440 |
| D-76204 Karlsruhe |

FARMASAN Arzneimittel GmbH & Co.KG

Postfach 410440

D-76204 Karlsruhe

Sponsin forte

0,833 mg

Prolonged-release capsule, hard

Oral use

Germany

| FARMASAN Arzneimittel GmbH & Co.KG, |
| --- |
| Postfach 410440 |
| D-76204 Karlsruhe, Germany |

FARMASAN Arzneimittel GmbH & Co.KG,

Postfach 410440

D-76204 Karlsruhe, Germany

Sponsin spezial

1,5 mg

Prolonged-release capsule, hard

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Hydro-Cebral-ratiopharm Tropfen

0,33 mg

Oral solution

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Hydro-Cebral-ratiopharm 2,5 mg

0,833 mg

Prolonged-release capsule, hard

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Hydro-Cebral-ratiopharm 5,0 mg

1,666 mg

Prolonged-release capsule, hard

Oral use

Greece

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| Marathonos 106 |
| GR-15344 Gerakas |

PHARMANEL PHARMACEUTICALS S.A.

Marathonos 106

GR-15344 Gerakas

Daverium

5 mg

Capsule, hard

Oral use

Greece

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| Marathonos 106 |
| GR-15344 Gerakas |

PHARMANEL PHARMACEUTICALS S.A.

Marathonos 106

GR-15344 Gerakas

Daverium

20 mg

Tablet

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12 Klm National Road No 1 |
| GR-14451 Athens |

Novartis (Hellas) S.A.C.I.

12 Klm National Road No 1

GR-14451 Athens

Hydergine LPD

0,1 % 15 ml

Oral solution

Oral use

Hungary

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

20 mg

Tablet

Oral use

Hungary

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

5 mg

Capsule

Oral use

Ireland

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

5mg

Capsule

Oral use

Ireland

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

20 mg

Tablet

Oral use

Italy

| MARVECSPHARMA SERVICES Srl |
| --- |
| Via Felice Casati, 16 |
| I-20124 Milano |

MARVECSPHARMA SERVICES Srl

Via Felice Casati, 16

I-20124 Milano

Daverium

20 mg

Tablet

Oral use

Italy

| Novartis Farma S.P.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio Varese |

Novartis Farma S.P.A.

Largo Umberto Boccioni 1

I-21040 Origgio Varese

Hydergina

1 mg

Oral solution

Oral use

Italy

| Novartis Farma S.P.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio Varese |

Novartis Farma S.P.A.

Largo Umberto Boccioni 1

I-21040 Origgio Varese

Hydergina

1,5 mg

Tablet

Oral use

Luxembourg

| NOVARTIS Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nurnberg |

NOVARTIS Pharma GmbH

Roonstraße 25

D-90429 Nurnberg

Hydergin 1 mg/ml Tropflösung

0,333 mg

Oral drops, solution

Oral use

Luxembourg

| NOVARTIS Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nurnberg |

NOVARTIS Pharma GmbH

Roonstraße 25

D-90429 Nurnberg

Hydergin forte 2 mg/ml Tropflösung

0,67 mg

Oral drops, solution

Oral use

Luxembourg

| NOVARTIS Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nurnberg |

NOVARTIS Pharma GmbH

Roonstraße 25

D-90429 Nurnberg

Hydergin Spezial

1,33 mg

Film-coated tablet

Oral use

Netherlands

| CENTRAFARM SERVICES B.V. |
| --- |
| Nieuwe Donk 9 |
| 4879 AC ETTEN-LEUR/NL |
| Nederland |

CENTRAFARM SERVICES B.V.

Nieuwe Donk 9

4879 AC ETTEN-LEUR/NL

Nederland

Co-dergocrinemesilaat

1,5 mg

Tablet

Oral use

Poland

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

20 mg

Tablet

Oral use

Portugal

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Cripar 20

20 mg

Tablet

Oral use

Portugal

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Cripar 5

5 mg

Capsule

Oral use

Portugal

| Novartis Farma |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| P-2710-44 Sintra |

Novartis Farma

Produtos Farmacêuticos S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

P-2710-44 Sintra

Hydergine 1,5 mg

1,5 mg

Tablet

Oral use

Portugal

| Novartis Farma |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| P-2710-44 Sintra |

Novartis Farma

Produtos Farmacêuticos S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

P-2710-44 Sintra

Hydergine 4,5 mg

4,5 mg

Tablet

Oral use

Portugal

| Novartis Farma |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| P-2710-44 Sintra |

Novartis Farma

Produtos Farmacêuticos S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

P-2710-44 Sintra

Hydergine 1 mg/ml

1 mg/ml

Oral drops, solution

Oral use

Portugal

| Novartis Farma |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua do Centro Empresarial |
| Edifício 8, Quinta da Beloura |
| P-2710-44 Sintra |

Novartis Farma

Produtos Farmacêuticos S.A.

Rua do Centro Empresarial

Edifício 8, Quinta da Beloura

P-2710-44 Sintra

Hydergine 3 mg/ml

3 mg/ml

Oral drops, solution

Oral use

Slovak Republic

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

20 mg

Tablet

Oral use

Slovak Republic

| POLICHEM S.A. |
| --- |
| 50, Val Fleuri |
| L-1526 Luxembourg |

POLICHEM S.A.

50, Val Fleuri

L-1526 Luxembourg

Almirid

5 mg

Capsule

Oral use

Spain

| Novartis Farmacéutica, S.A. |
| --- |
| Gran Via de los Corts Catalanes, número 184 |
| E-08013 Barcelona |

Novartis Farmacéutica, S.A.

Gran Via de los Corts Catalanes, número 184

E-08013 Barcelona

Hydergina

4,5 mg

Tablet

Oral use

Spain

| Novartis Farmacéutica, S.A. |
| --- |
| Gran Via de los Corts Catalanes, número 184 |
| E-08013 Barcelona |

Novartis Farmacéutica, S.A.

Gran Via de los Corts Catalanes, número 184

E-08013 Barcelona

Hydergina

1 mg/ml

Oral solution

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B |
| Box 1150 |
| S-183 11 Täby |

Novartis Sverige AB

Kemistvägen 1B

Box 1150

S-183 11 Täby

Hydergine

1 mg

Tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals Ltd

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Hydergine 1,5 mg

1,5 mg

Tablet

Oral use

United Kingdom

| Novartis Pharmaceuticals Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals Ltd

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Hydergine 4,5 mg

4,5 mg

Tablet

Oral use

Lisuride containing medicinal products with Marketing Authorisation in the European Union

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | BAYER GmbH |
| Herbststraße 6-10 |
| A-1160 Wien |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical Form

Route of administration

Austria

BAYER GmbH

Herbststraße 6-10

A-1160 Wien

Dopergin — Tabletten

0,2 mg

Tablet

Oral use

France

| LABO LISA pharm |
| --- |
| 9 bis, boulevard J. Jaures |
| F-92100 Boulogne Billancourt |

LABO LISA pharm

9 bis, boulevard J. Jaures

F-92100 Boulogne Billancourt

Arolac

0,2mg

Tablet

Oral use

France

| Bayer Schering Pharma |
| --- |
| ZI roubaix est rue de touflers |
| F-59390 Lys-les-Lannoy |

Bayer Schering Pharma

ZI roubaix est rue de touflers

F-59390 Lys-les-Lannoy

Dopergine

0,2 mg

Tablet

Oral use

France

| Bayer Schering Pharma |
| --- |
| ZI roubaix est rue de touflers |
| F-59390 Lys-les-Lannoy |

Bayer Schering Pharma

ZI roubaix est rue de touflers

F-59390 Lys-les-Lannoy

Dopergine

0,5mg

Tablet

Oral use

Germany

| BAYER Vital GmbH |
| --- |
| D-51368 Leverkusen |

BAYER Vital GmbH

D-51368 Leverkusen

Dopergin-0,5 mg Tablette

0,5 mg

Tablet

Oral use

Germany

| BAYER Vital GmbH |
| --- |
| D-51368 Leverkusen |

BAYER Vital GmbH

D-51368 Leverkusen

Dopergin-0,2 mg Tablette

0.2 mg

Tablet

Oral use

Italy

| SCHERING SpA |
| --- |
| Via E. Schering, 21 |
| I-20090 Segrate (MI) |

SCHERING SpA

Via E. Schering, 21

I-20090 Segrate (MI)

Dopergin

0,2 mg

Tablet

Oral use

Italy

| SCHERING SpA |
| --- |
| Via E. Schering, 21 |
| I-20090 Segrate (MI) |

SCHERING SpA

Via E. Schering, 21

I-20090 Segrate (MI)

Dopergin

0,5 mg

Tablet

Oral use

Spain

| Química Farmaceutica Bayer |
| --- |
| SL, Pau Claris, 196 |
| E-08037 Barcelona |

Química Farmaceutica Bayer

SL, Pau Claris, 196

E-08037 Barcelona

Dopergin 0,2 mg comprimidos

0,2 mg

Tablet

Oral use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Cabergoline containing medicinal products with Marketing Authorisation in the European Union

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | PFIZER Corporation Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical Form

Route of administration

Austria

PFIZER Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Cabaseril

2 mg

Tablet

Oral use

Austria

| PFIZER Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

PFIZER Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Cabaseril

4 mg

Tablet

Oral use

Austria

| PFIZER Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

PFIZER Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Cabaseril

1 mg

Tablet

Oral use

Austria

| PFIZER Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

PFIZER Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Dostinex

0,5 mg

Tablet

Oral use

Austria

| SANDOZ GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

SANDOZ GmbH

Biochemiestraße 10

A-6250 Kundl

Cabergolin ‘Sandoz’ 0,5 mg — Tabletten

0,5 mg

Tablet

Oral use

Austria

| SANDOZ GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

SANDOZ GmbH

Biochemiestraße 10

A-6250 Kundl

Cabergolin ‘Sandoz’ 1 mg — Tabletten

1 mg

Tablet

Oral use

Austria

| SANDOZ GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

SANDOZ GmbH

Biochemiestraße 10

A-6250 Kundl

Cabergolin ‘Sandoz’ 2 mg — Tabletten

2 mg

Tablet

Oral use

Austria

| SANDOZ GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

SANDOZ GmbH

Biochemiestraße 10

A-6250 Kundl

Cabergolin ‘Sandoz’ 4 mg — Tabletten

4 mg

Tablet

Oral use

Austria

| TEVA Pharmaceuticals Europe B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Nederland |

TEVA Pharmaceuticals Europe B.V.

Computerweg 10

3542 DR Utrecht

Nederland

Cabergolin Teva 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Austria

| TEVA Pharmaceuticals Europe B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Nederland |

TEVA Pharmaceuticals Europe B.V.

Computerweg 10

3542 DR Utrecht

Nederland

Cabergolin Teva 1 mg Tabletten

1 mg

Tablet

Oral use

Austria

| TEVA Pharmaceuticals Europe B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Nederland |

TEVA Pharmaceuticals Europe B.V.

Computerweg 10

3542 DR Utrecht

Nederland

Cabergolin Teva 2 mg Tabletten

2 mg

Tablet

Oral use

Austria

| TEVA Pharmaceuticals Europe B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Nederland |

TEVA Pharmaceuticals Europe B.V.

Computerweg 10

3542 DR Utrecht

Nederland

Cabergolin Teva 4 mg Tabletten

4 mg

Tablet

Oral use

Belgium

| PFIZER S.A |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Bruxelles |

PFIZER S.A

Boulevard de la Plaine 17

B-1050 Bruxelles

Dostinex

0,5 mg

Tablet

Oral use

Belgium

| PFIZER S.A |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Bruxelles |

PFIZER S.A

Boulevard de la Plaine 17

B-1050 Bruxelles

Sostilar

0,5 mg

Tablet

Oral use

Belgium

| TEVA Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

TEVA Pharma Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Cabergoline Teva 0,5 mg

0,5 mg

Tablet

Oral use

Belgium

| TEVA Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

TEVA Pharma Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Cabergoline Teva 1 mg

1 mg

Tablet

Oral use

Belgium

| TEVA Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

TEVA Pharma Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Cabergoline Teva 2 mg

2 mg

Tablet

Oral use

Belgium

| TEVA Pharma Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

TEVA Pharma Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Cabergoline Teva 4 mg

4 mg

Tablet

Oral use

Bulgaria

| Pfizer Enterprises SÀRL |
| --- |
| Rond Point du Kirchberg/51, avenue JF Kennedy |
| L-1855 Luxembourg |

Pfizer Enterprises SÀRL

Rond Point du Kirchberg/51, avenue JF Kennedy

L-1855 Luxembourg

Dostinex

0,5 mg

Tablet

Oral use

Bulgaria

| Pfizer Enterprises SÀRL |
| --- |
| Rond Point du Kirchberg/51, avenue JF Kennedy |
| L-1855 Luxembourg |

Pfizer Enterprises SÀRL

Rond Point du Kirchberg/51, avenue JF Kennedy

L-1855 Luxembourg

Cabaser

2 mg

Tablet

Oral use

Bulgaria

| Pfizer Enterprises SÀRL |
| --- |
| Rond Point du Kirchberg/51, avenue JF Kennedy |
| L-1855 Luxembourg |

Pfizer Enterprises SÀRL

Rond Point du Kirchberg/51, avenue JF Kennedy

L-1855 Luxembourg

Cabaser

1 mg

Tablet

Oral use

Cyprus

| GEO PAVLIDES & ARAOUZOS Ltd |
| --- |
| P.O.Box 24899 |
| CY-1305 Lefkosia |

GEO PAVLIDES & ARAOUZOS Ltd

P.O.Box 24899

CY-1305 Lefkosia

Dostinex

0,5 mg

Tablet

Oral use

Cyprus

| TEVA Pharma B.V. |
| --- |
| P.O. Box 43011 |
| 3540 AA Utrecht |
| Nederland |

TEVA Pharma B.V.

P.O. Box 43011

3540 AA Utrecht

Nederland

Cabergoline Teva

1 mg

Tablet

Oral use

Cyprus

| TEVA Pharma B.V. |
| --- |
| P.O. Box 43011 |
| 3540 AA Utrecht, |
| Nederland |

TEVA Pharma B.V.

P.O. Box 43011

3540 AA Utrecht,

Nederland

Cabergoline Teva

2 mg

Tablet

Oral use

Cyprus

| TEVA Pharma B.V. |
| --- |
| P.O. Box 43011 |
| 3540 AA Utrecht |
| Nederland |

TEVA Pharma B.V.

P.O. Box 43011

3540 AA Utrecht

Nederland

Cabergoline Teva

4 mg

Tablet

Oral use

Cyprus

| TEVA Pharma B.V. |
| --- |
| P.O. Box 43011 |
| 3540 AA Utrecht |
| Nederland |

TEVA Pharma B.V.

P.O. Box 43011

3540 AA Utrecht

Nederland

Cabergoline Teva

0,5 mg

Tablet

Oral use

Czech Republic

| PFIZER spol. s. r. o. |
| --- |
| Stroupežnického 17 |
| CZ-150 00 Praha 5 |

PFIZER spol. s. r. o.

Stroupežnického 17

CZ-150 00 Praha 5

Dostinex

0,5 mg

Tablet

Oral use

Czech Republic

| HEXAL |
| --- |
| Industriestraβe 25 |
| D-83607 Holzkirchen |

HEXAL

Industriestraβe 25

D-83607 Holzkirchen

Cabergolin Sandoz 0,5 mg

0,5 mg

Tablet

Oral use

Czech Republic

| HEXAL |
| --- |
| Industriestraβe 25 |
| D-83607 Holzkirchen |

HEXAL

Industriestraβe 25

D-83607 Holzkirchen

Cabergolin Sandoz 1 mg

1 mg

Tablet

Oral use

Czech Republic

| HEXAL |
| --- |
| Industriestraβe 25 |
| D-83607 Holzkirchen |

HEXAL

Industriestraβe 25

D-83607 Holzkirchen

Cabergolin Sandoz 2 mg

2 mg

Tablet

Oral use

Czech Republic

| HEXAL |
| --- |
| Industriestraβe 25 |
| D-83607 Holzkirchen |

HEXAL

Industriestraβe 25

D-83607 Holzkirchen

Cabergolin Sandoz 4 mg

4 mg

Tablet

Oral use

Czech Republic

| TEVA Pharmaceuticals ČR s. r. o. |
| --- |
| Radlická 3185/1C |
| CZ-150 00 Praha 5 |

TEVA Pharmaceuticals ČR s. r. o.

Radlická 3185/1C

CZ-150 00 Praha 5

Cabera

0,5 mg

Tablet

Oral use

Czech Republic

| TEVA Pharmaceuticals ČR s. r. o. |
| --- |
| Radlická 3185/1C |
| CZ-150 00 Praha 5 |

TEVA Pharmaceuticals ČR s. r. o.

Radlická 3185/1C

CZ-150 00 Praha 5

Cabera

1 mg

Tablet

Oral use

Czech Republic

| TEVA Pharmaceuticals ČR s. r. o. |
| --- |
| Radlická 3185/1C |
| CZ-150 00 Praha 5 |

TEVA Pharmaceuticals ČR s. r. o.

Radlická 3185/1C

CZ-150 00 Praha 5

Cabera

2 mg

Tablet

Oral use

Czech Republic

| TEVA Pharmaceuticals ČR s. r. o. |
| --- |
| Radlická 3185/1C |
| CZ-150 00 Praha 5 |

TEVA Pharmaceuticals ČR s. r. o.

Radlická 3185/1C

CZ-150 00 Praha 5

Cabera

4 mg

Tablet

Oral use

Denmark

| PFIZER Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

PFIZER Aps

Lautrupvang 8

DK-2750 Ballerup

Cabaser

1 mg

Tablet

Oral use

Denmark

| PFIZER Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

PFIZER Aps

Lautrupvang 8

DK-2750 Ballerup

Cabaser

2 mg

Tablet

Oral use

Denmark

| PFIZER Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

PFIZER Aps

Lautrupvang 8

DK-2750 Ballerup

Cabaser

4 mg

Tablet

Oral use

Denmark

| PFIZER Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

PFIZER Aps

Lautrupvang 8

DK-2750 Ballerup

Dostinex

0,5 mg

Tablet

Oral use

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergolin ‘Hexal’

1 mg

Tablet

Oral use

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergolin ‘Hexal’

2 mg

Tablet

Oral use

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergolin ‘Hexal’

4 mg

Tablet

Oral use

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergolin ‘Hexal’

0,5 mg

Tablet

Oral use

Finland

| PFIZER OY |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |

PFIZER OY

Tietokuja 4

FI-00330 Helsinki

Cabaser

1 mg

Tablet

Oral use

Finland

| PFIZER OY |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |

PFIZER OY

Tietokuja 4

FI-00330 Helsinki

Cabaser

2 mg

Tablet

Oral use

Finland

| PFIZER OY |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |

PFIZER OY

Tietokuja 4

FI-00330 Helsinki

Cabaser

4 mg

Tablet

Oral use

Finland

| PFIZER OY |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |

PFIZER OY

Tietokuja 4

FI-00330 Helsinki

Cabaser

1 mg

Tablet

Oral use

Finland

| PFIZER OY |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |

PFIZER OY

Tietokuja 4

FI-00330 Helsinki

Cabaser

2 mg

Tablet

Oral use

Finland

| PFIZER OY |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |

PFIZER OY

Tietokuja 4

FI-00330 Helsinki

Cabaser

4 mg

Tablet

Oral use

Finland

| PFIZER OY |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |

PFIZER OY

Tietokuja 4

FI-00330 Helsinki

Dostinex

0,5 mg

Tablet

Oral use

France

| PFIZER holding France |
| --- |
| 23-25, rue du docteur Lannelongue |
| F-75014 Paris |

PFIZER holding France

23-25, rue du docteur Lannelongue

F-75014 Paris

Dostinex

0,5 mg

Tablet

Oral use

France

| PFIZER holding France |
| --- |
| 23-25, rue du docteur Lannelongue |
| F-75014 Paris |

PFIZER holding France

23-25, rue du docteur Lannelongue

F-75014 Paris

Cabaser

1 mg

Tablet

Oral use

France

| PFIZER holding France |
| --- |
| 23-25, rue du docteur Lannelongue |
| F-75014 Paris |

PFIZER holding France

23-25, rue du docteur Lannelongue

F-75014 Paris

Cabaser

2 mg

Tablet

Oral use

France

| PFIZER holding France |
| --- |
| 23-25, rue du docteur Lannelongue |
| F-75014 Paris |

PFIZER holding France

23-25, rue du docteur Lannelongue

F-75014 Paris

Cabaser

4 mg

Tablet

Oral use

Germany

| PHARMACIA GmbH |
| --- |
| Pfizerstr. 1 |
| D-76139 Karlsruhe |

PHARMACIA GmbH

Pfizerstr. 1

D-76139 Karlsruhe

Dostinex

0,5 mg

Tablet

Oral use

Germany

| PHARMACIA GmbH |
| --- |
| Pfizerstr. 1 |
| D-76139 Karlsruhe |

PHARMACIA GmbH

Pfizerstr. 1

D-76139 Karlsruhe

Cabaseril

1 mg

Tablet

Oral use

Germany

| PHARMACIA GmbH |
| --- |
| Pfizerstr. 1 |
| D-76139 Karlsruhe |

PHARMACIA GmbH

Pfizerstr. 1

D-76139 Karlsruhe

Cabaseril

2 mg

Tablet

Oral use

Germany

| PHARMACIA GmbH |
| --- |
| Pfizerstr. 1 |
| D-76139 Karlsruhe |

PHARMACIA GmbH

Pfizerstr. 1

D-76139 Karlsruhe

Cabaseril

4 mg

Tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co.KG |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |

ALIUD PHARMA GmbH & Co.KG

Postfach 1380

D-89146 Laichingen

Cabergolin AL 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co.KG |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |

ALIUD PHARMA GmbH & Co.KG

Postfach 1380

D-89146 Laichingen

Cabergolin AL 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co.KG |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |

ALIUD PHARMA GmbH & Co.KG

Postfach 1380

D-89146 Laichingen

Cabergolin AL 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| ALIUD PHARMA GmbH & Co.KG |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |

ALIUD PHARMA GmbH & Co.KG

Postfach 1380

D-89146 Laichingen

Cabergolin AL 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

Cabergolin-CT 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

Cabergolin-CT 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

Cabergolin-CT 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Cabergolin HEXAL 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Cabergolin HEXAL 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Cabergolin HEXAL 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Cabergolin HEXAL 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergolin dura 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergolin dura 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergolin dura 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergolin dura 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Cabergolin Sandoz 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Cabergolin Sandoz 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Cabergolin Sandoz 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Cabergolin Sandoz 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| STADAPHARM GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADAPHARM GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Cabergolin STADA 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| STADAPHARM GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADAPHARM GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Cabergolin STADA 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| STADAPHARM GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADAPHARM GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Cabergolin STADA 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| STADAPHARM GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADAPHARM GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Cabergolin STADA 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergo-TEVA 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergolin-TEVA 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergo-TEVA 1 mg Tabletten

1. mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergolin-TEVA 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergo-TEVA 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergolin-TEVA 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergo-TEVA 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergolin-TEVA 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Cabergolin-ratiopharm 0,5 mg Tabletten

0,5 mg

Tablet

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Cabergolin-ratiopharm 1 mg Tabletten

1 mg

Tablet

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Cabergolin-ratiopharm 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Cabergolin-ratiopharm 4 mg Tabletten

4 mg

Tablet

Oral use

Iceland

| PFIZER Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

PFIZER Aps

Lautrupvang 8

DK-2750 Ballerup

Dostinex

0,5 mg

Tablet

Oral use

Ireland

| PHARMACIA Ireland Limited |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

PHARMACIA Ireland Limited

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Cabaser

1 mg

Tablet

Oral use

Ireland

| PHARMACIA Ireland Limited |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

PHARMACIA Ireland Limited

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Cabaser

2 mg

Tablet

Oral use

Ireland

| PHARMACIA Ireland Limited |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

PHARMACIA Ireland Limited

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Dostinex

0,5 mg

Tablet

Oral use

Ireland

| PHARMACIA Laboratories Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| England |

PHARMACIA Laboratories Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

England

| Mailing Address: Pharmacia Ireland Limited |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Mailing Address: Pharmacia Ireland Limited

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Cabaser

4 mg

Tablet

Oral use

Italy

| PFIZER ITALIA Srl |
| --- |
| Strada Statale, Borgo San Michele SS 156 km 50 |
| I-04010 Latina |

PFIZER ITALIA Srl

Strada Statale, Borgo San Michele SS 156 km 50

I-04010 Latina

Cabaser

4 mg

Tablet

Oral use

Italy

| PFIZER ITALIA Srl |
| --- |
| Strada Statale, Borgo San Michele SS 156 km 50 |
| I-04010 Latina |

PFIZER ITALIA Srl

Strada Statale, Borgo San Michele SS 156 km 50

I-04010 Latina

Dostinex

0,5 mg

Tablet

Oral use

Italy

| PFIZER ITALIA Srl |
| --- |
| Strada Statale, Borgo San Michele SS 156 km 50 |
| I-04010 Latina |

PFIZER ITALIA Srl

Strada Statale, Borgo San Michele SS 156 km 50

I-04010 Latina

Cabaser

1 mg

Tablet

Oral use

Italy

| PFIZER ITALIA Srl |
| --- |
| Strada Statale, Borgo San Michele SS 156 km 50 |
| I-04010 Latina |

PFIZER ITALIA Srl

Strada Statale, Borgo San Michele SS 156 km 50

I-04010 Latina

Cabaser

2 mg

Tablet

Oral use

Latvia

| PFIZER ITALIA Srl |
| --- |
| Strada Statale, Borgo San Michele SS 156 km 50 |
| I-04010 Latina |

PFIZER ITALIA Srl

Strada Statale, Borgo San Michele SS 156 km 50

I-04010 Latina

Dostinex

0,5 mg

Tablet

Oral use

Lithuania

| PFIZER Italia S.r.l. |
| --- |
| Via del Commercio 25/27 |
| I-63046 Marino del Tronto |

PFIZER Italia S.r.l.

Via del Commercio 25/27

I-63046 Marino del Tronto

Dostinex

0,5 mg

Tablet

Oral use

Luxembourg

| PFIZER S.A |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Bruxelles |

PFIZER S.A

Boulevard de la Plaine 17

B-1050 Bruxelles

Dostinex

0,5 mg

Tablet

Oral use

Luxembourg

| PFIZER S.A |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Bruxelles |

PFIZER S.A

Boulevard de la Plaine 17

B-1050 Bruxelles

Sostilar

0,5 mg

Tablet

Oral use

Malta

| PFIZER Hellas SA |
| --- |
| 243, Messoghion Avenue |
| GR-154 51 N.Psychiko |

PFIZER Hellas SA

243, Messoghion Avenue

GR-154 51 N.Psychiko

Dostinex

0,5 mg

Tablet

Oral use

Malta

| TEVA Pharma BV |
| --- |
| Industrieweg 23 |
| PO Bpx 217 |
| 3640 AE Mijdrecht |
| Nederland |

TEVA Pharma BV

Industrieweg 23

PO Bpx 217

3640 AE Mijdrecht

Nederland

Cabergoline Teva

0,5 mg

Tablet

Oral use

Malta

| TEVA Pharma BV |
| --- |
| Industrieweg 23 |
| PO Bpx 217 |
| 3640 AE Mijdrecht |
| Nederland |

TEVA Pharma BV

Industrieweg 23

PO Bpx 217

3640 AE Mijdrecht

Nederland

Cabergoline Teva

1 mg

Tablet

Oral use

Malta

| TEVA Pharma BV |
| --- |
| Industrieweg 23 |
| PO Bpx 217 |
| 3640 AE Mijdrecht |
| Nederland |

TEVA Pharma BV

Industrieweg 23

PO Bpx 217

3640 AE Mijdrecht

Nederland

Cabergoline Teva

2 mg

Tablet

Oral use

Malta

| TEVA Pharma BV |
| --- |
| Industrieweg 23 |
| PO Bpx 217 |
| 3640 AE Mijdrecht |
| Nederland |

TEVA Pharma BV

Industrieweg 23

PO Bpx 217

3640 AE Mijdrecht

Nederland

Cabergoline Teva

4 mg

Tablet

Oral use

Netherlands

| PFIZER B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJSSEL |
| Nederland |

PFIZER B.V.

Rivium Westlaan 142

2909 LD Capelle a/d IJSSEL

Nederland

Dostinex

0,5 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Cabergoline Sandoz 0,5 mg

0,5 mg

Tablet

Oral use

Netherlands

| PHARMACHEMIE B.V. |
| --- |
| Swensweg 5 |
| Haarlem |
| Nederland |

PHARMACHEMIE B.V.

Swensweg 5

Haarlem

Nederland

Cabergoline 0,5 PCH

0,5 mg

Tablet

Oral use

Norway

| PFIZER AS |
| --- |
| Postboks 3 |
| N-1324 Lysaker |

PFIZER AS

Postboks 3

N-1324 Lysaker

Dostinex

0,5 mg

Tablet

Oral use

Norway

| PFIZER AS |
| --- |
| Postboks 3 |
| N-1324 Lysaker |

PFIZER AS

Postboks 3

N-1324 Lysaker

Cabaser

1 mg

Tablet

Oral use

Norway

| PFIZER AS |
| --- |
| Postboks 3 |
| N-1324 Lysaker |

PFIZER AS

Postboks 3

N-1324 Lysaker

Cabaser

2 mg

Tablet

Oral use

Norway

| PFIZER AS |
| --- |
| Postboks 3 |
| N-1324 Lysaker |

PFIZER AS

Postboks 3

N-1324 Lysaker

Cabaser

4 mg

Tablet

Oral use

Norway

| TEVA Sweden AB |
| --- |
| Sundstorget 2 |
| Helsingborg |
| P.O. Box 1070 |
| S-251 10 Helsingborg |

TEVA Sweden AB

Sundstorget 2

Helsingborg

P.O. Box 1070

S-251 10 Helsingborg

Karbegolin Teva

0,5 mg

Tablet

Oral use

Norway

| TEVA Sweden AB |
| --- |
| Sundstorget 2 |
| Helsingborg |
| P.O. Box 1070 |
| S-251 10 Helsingborg |

TEVA Sweden AB

Sundstorget 2

Helsingborg

P.O. Box 1070

S-251 10 Helsingborg

Karbegolin Teva

1 mg

Tablet

Oral use

Norway

| TEVA Sweden AB |
| --- |
| Sundstorget 2 |
| Helsingborg |
| P.O. Box 1070 |
| S-251 10 Helsingborg |

TEVA Sweden AB

Sundstorget 2

Helsingborg

P.O. Box 1070

S-251 10 Helsingborg

Karbegolin Teva

2 mg

Tablet

Oral use

Norway

| TEVA Sweden AB |
| --- |
| Sundstorget 2 |
| Helsingborg |
| P.O. Box 1070 |
| S-251 10 Helsingborg |

TEVA Sweden AB

Sundstorget 2

Helsingborg

P.O. Box 1070

S-251 10 Helsingborg

Karbegolin Teva

4 mg

Tablet

Oral use

Poland

| LEK farmaceutska družba d.d. |
| --- |
| Verovškova 57 |
| SLO-1526 Ljubljana |

LEK farmaceutska družba d.d.

Verovškova 57

SLO-1526 Ljubljana

CabergoLek 0,5

0,5 mg

Tablet

Oral use

Poland

| LEK farmaceutska družba d.d. |
| --- |
| Verovškova 57 |
| SLO-1526 Ljubljana |

LEK farmaceutska družba d.d.

Verovškova 57

SLO-1526 Ljubljana

CabergoLek 1

1 mg

Tablet

Oral use

Poland

| LEK farmaceutska družba d.d. |
| --- |
| Verovškova 57 |
| SLO-1526 Ljubljana |

LEK farmaceutska družba d.d.

Verovškova 57

SLO-1526 Ljubljana

CabergoLek 2

2 mg

Tablet

Oral use

Poland

| LEK farmaceutska družba d.d. |
| --- |
| Verovškova 57 |
| SLO-1526 Ljubljana |

LEK farmaceutska družba d.d.

Verovškova 57

SLO-1526 Ljubljana

CabergoLek 4

4 mg

Tablet

Oral use

Poland

| PHARMACIA & UPJOHN S.p.A. |
| --- |
| Via Robert Koch 1,2 |
| I-20152 Milano |

PHARMACIA & UPJOHN S.p.A.

Via Robert Koch 1,2

I-20152 Milano

Cabaser

1 mg

Tablet

Oral use

Poland

| PHARMACIA & UPJOHN S.p.A. |
| --- |
| Via Robert Koch 1,2 |
| I-20152 Milano |

PHARMACIA & UPJOHN S.p.A.

Via Robert Koch 1,2

I-20152 Milano

Cabaser

2 mg

Tablet

Oral use

Poland

| PHARMACIA & UPJOHN S.p.A. |
| --- |
| Via Robert Koch 1,2 |
| I-20152 Milano |

PHARMACIA & UPJOHN S.p.A.

Via Robert Koch 1,2

I-20152 Milano

Cabaser

4 mg

Tablet

Oral use

Poland

| PHARMACIA ITALIA S.p.A. |
| --- |
| Via Robert Koch 1,2 |
| I-20152 Milano |

PHARMACIA ITALIA S.p.A.

Via Robert Koch 1,2

I-20152 Milano

Dostinex

0,5 mg

Tablet

Oral use

Portugal

| Laboratorios PFIZER Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 10 |
| P-2740-271 Porto Salvo |

Laboratorios PFIZER Lda.

Empreendimento Lagoas Park

Edifício 10

P-2740-271 Porto Salvo

Dostinex

0,5 mg

Tablet

Oral use

Portugal

| TEVA Pharma — Produtos Farmacêuticos Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 1-3 |
| P-2740-264 Porto Salvo |

TEVA Pharma — Produtos Farmacêuticos Lda.

Empreendimento Lagoas Park

Edifício 1-3

P-2740-264 Porto Salvo

Cabergolina Teva

0,5 mg

Tablet

Oral use

Romania

| PFIZER Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PFIZER Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Dostinex

0,5mg

Tablet

Oral use

Slovakia

| TEVA Pharmaceuticals CR s. r. o. |
| --- |
| Drážní 7 |
| CZ-627 00 Brno |

TEVA Pharmaceuticals CR s. r. o.

Drážní 7

CZ-627 00 Brno

Cabest 0,5 mg

0,5 mg

Tablet

Oral use

Slovakia

| TEVA Pharmaceuticals CR s. r. o. |
| --- |
| Drážní 7 |
| CZ-627 00 Brno |

TEVA Pharmaceuticals CR s. r. o.

Drážní 7

CZ-627 00 Brno

Cabest 1 mg

1 mg

Tablet

Oral use

Slovakia

| TEVA Pharmaceuticals CR s. r. o. |
| --- |
| Drážní 7 |
| CZ-627 00 Brno |

TEVA Pharmaceuticals CR s. r. o.

Drážní 7

CZ-627 00 Brno

Cabest 2 mg

2 mg

Tablet

Oral use

Slovakia

| TEVA Pharmaceuticals CR s. r. o. |
| --- |
| Drážní 7 |
| CZ-627 00 Brno |

TEVA Pharmaceuticals CR s. r. o.

Drážní 7

CZ-627 00 Brno

Cabest 4 mg

4 mg

Tablet

Oral use

Spain

| PFIZER SA |
| --- |
| Avda. Europa 20, B parque empresarial la Moraleja |
| Alcobendas |
| Spain |

PFIZER SA

Avda. Europa 20, B parque empresarial la Moraleja

Alcobendas

Spain

Sogilen 1 mg comprimidos

1mg

Tablet

Oral use

Spain

| PFIZER SA |
| --- |
| Avda. Europa 20, B parque empresarial la Moraleja |
| Alcobendas |
| Spain |

PFIZER SA

Avda. Europa 20, B parque empresarial la Moraleja

Alcobendas

Spain

Sogilen 2 mg comprimidos

2 mg

Tablet

Oral use

Spain

| PFIZER SA |
| --- |
| Avda. Europa 20, B parque empresarial la Moraleja |
| Alcobendas |
| Spain |

PFIZER SA

Avda. Europa 20, B parque empresarial la Moraleja

Alcobendas

Spain

Sogilen 4 mg comprimidos

4 mg

Tablet

Oral use

Spain

| PFIZER SA |
| --- |
| Avda. Europa 20, B parque empresarial la Moraleja |
| Alcobendas |
| Spain |

PFIZER SA

Avda. Europa 20, B parque empresarial la Moraleja

Alcobendas

Spain

Doxtinex comprimidos

0,5 mg

Tablet

Oral use

Sweden

| PFIZER AB |
| --- |
| S-191 90 Sollentuna |

PFIZER AB

S-191 90 Sollentuna

Dostinex

0,5 mg

Tablet

Oral use

Sweden

| PFIZER AB |
| --- |
| S-191 90 Sollentuna |

PFIZER AB

S-191 90 Sollentuna

Cabser

1 mg

Tablet

Oral use

Sweden

| PFIZER AB |
| --- |
| S-191 90 Sollentuna |

PFIZER AB

S-191 90 Sollentuna

Cabser

2 mg

Tablet

Oral use

Sweden

| PFIZER AB |
| --- |
| S-191 90 Sollentuna |

PFIZER AB

S-191 90 Sollentuna

Cabser

4 mg

Tablet

Oral use

Sweden

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

Cabergoline CT

1 mg

Tablet

Oral use

Sweden

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

Cabergoline CT

2 mg

Tablet

Oral use

Sweden

| CT-ARZNEIMITTEL GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-ARZNEIMITTEL GmbH

Lengeder Str. 42a

D-13407 Berlin

Cabergoline CT

4 mg

Tablet

Oral use

Sweden

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergoline Hexal

0,5 mg

Tablet

Oral use

Sweden

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergoline Hexal

1 mg

Tablet

Oral use

Sweden

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergoline Hexal

2 mg

Tablet

Oral use

Sweden

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Cabergoline Hexal

4 mg

Tablet

Oral use

Sweden

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergodura

0,5 mg

Tablet

Oral use

Sweden

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergodura

1 mg

Tablet

Oral use

Sweden

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergodura

2 mg

Tablet

Oral use

Sweden

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Cabergodura

4 mg

Tablet

Oral use

Sweden

| RATIOPHARM GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Cabergoline ratiopharm

0,5 mg

Tablet

Oral use

Sweden

| RATIOPHARM GmbH, |
| --- |
| Graf-Arco-Straße 3, |
| D-89079 Ulm |

RATIOPHARM GmbH,

Graf-Arco-Straße 3,

D-89079 Ulm

Cabergoline ratiopharm

1 mg

Tablet

Oral use

Sweden

| RATIOPHARM GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Cabergoline ratiopharm

2 mg

Tablet

Oral use

Sweden

| RATIOPHARM GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Cabergoline ratiopharm

4 mg

Tablet

Oral use

Sweden

| SANDOZ A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |

SANDOZ A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Cabergonicht

0,5 mg

Tablet

Oral use

Sweden

| SANDOZ A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |

SANDOZ A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Cabergonicht

1 mg

Tablet

Oral use

Sweden

| SANDOZ A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |

SANDOZ A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Cabergonicht

2 mg

Tablet

Oral use

Sweden

| SANDOZ A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |

SANDOZ A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Cabergonicht

4 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergolin STADA

0,5 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergolin STADA

1 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergolin STADA

2 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergolin STADA

4 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergostad

0,5 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergostad

1 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergostad

2 mg

Tablet

Oral use

Sweden

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Kabergostad

4 mg

Tablet

Oral use

Sweden

| IVAX Scandinavia AB |
| --- |
| Mailbox 386 |
| S-111 73 Stockholm |

IVAX Scandinavia AB

Mailbox 386

S-111 73 Stockholm

Kabergolin IVAX

0,5 mg

Tablet

Oral use

Sweden

| IVAX Scandinavia AB |
| --- |
| Mailbox 386 |
| S-111 73 Stockholm |

IVAX Scandinavia AB

Mailbox 386

S-111 73 Stockholm

Kabergolin IVAX

1 mg

Tablet

Oral use

Sweden

| IVAX Scandinavia AB |
| --- |
| Mailbox 386 |
| S-111 73 Stockholm |

IVAX Scandinavia AB

Mailbox 386

S-111 73 Stockholm

Kabergolin IVAX

2 mg

Tablet

Oral use

Sweden

| IVAX Scandinavia AB |
| --- |
| Mailbox 386 |
| S-111 73 Stockholm |

IVAX Scandinavia AB

Mailbox 386

S-111 73 Stockholm

Kabergolin IVAX

4 mg

Tablet

Oral use

Sweden

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergoteva

0,5 mg

Tablet

Oral use

Sweden

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergoteva

1 mg

Tablet

Oral use

Sweden

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergoteva

2 mg

Tablet

Oral use

Sweden

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Cabergoteva

4 mg

Tablet

Oral use

Sweden

| 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

Cabergoline Teva

0,5 mg

Tablet

Oral use

Sweden

| 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

Cabergoline Teva

1 mg

Tablet

Oral use

Sweden

| 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

Cabergoline Teva

2 mg

Tablet

Oral use

Sweden

| 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

Cabergoline Teva

4 mg

Tablet

Oral use

United Kingdom

| PHARMACIA Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PHARMACIA Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Dostinex

0,5 mg

Tablet

Oral use

United Kingdom

| PHARMACIA Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PHARMACIA Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Cabaser

1 mg

Tablet

Oral use

United Kingdom

| PHARMACIA Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PHARMACIA Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Cabaser

2 mg

Tablet

Oral use

United Kingdom

| PHARMACIA Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

PHARMACIA Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Cabaser

4 mg

Tablet

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

Cabergoline 0,5 mg tablet

0,5 mg

Tablet

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

Cabergoline 1 mg tablet

1 mg

Tablet

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

Cabergoline 2 mg tablet

2 mg

Tablet

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

Cabergoline 4 mg tablet

4 mg

Tablet

Oral use

Pergolide containing medicinal products with Marketing Authorisation in the European Union

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | ELI LILLY GmbH |
| Kölblgasse 8-10 |
| A-1030 Wien |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical Form

Route of administration

Austria

ELI LILLY GmbH

Kölblgasse 8-10

A-1030 Wien

Permax 0,05 mg — Tabletten

0,05 mg

Tablet

Oral use

Austria

| ELI LILLY GmbH |
| --- |
| Kölblgasse 8-10 |
| A-1030 Wien |

ELI LILLY GmbH

Kölblgasse 8-10

A-1030 Wien

Permax 0,25 mg — Tabletten

0,25 mg

Tablet

Oral use

Austria

| ELI LILLY GmbH |
| --- |
| Kölblgasse 8-10 |
| A-1030 Wien |

ELI LILLY GmbH

Kölblgasse 8-10

A-1030 Wien

Permax 1 mg — Tabletten

1 mg

Tablet

Oral use

Belgium

| ELI LILLY BENELUX S.A. |
| --- |
| rue de l'Etuve, 52 |
| B-1000 Brussels |

ELI LILLY BENELUX S.A.

rue de l'Etuve, 52

B-1000 Brussels

Permax 0,05 mg

0,05 mg

Tablet

Oral use

Belgium

| ELI LILLY BENELUX S.A. |
| --- |
| rue de l'Etuve, 52 |
| B-1000 Brussels |

ELI LILLY BENELUX S.A.

rue de l'Etuve, 52

B-1000 Brussels

Permax 0,25 mg

0,25 mg

Tablet

Oral use

Belgium

| ELI LILLY BENELUX S.A. |
| --- |
| rue de l'Etuve, 52 |
| B-1000 Brussels |

ELI LILLY BENELUX S.A.

rue de l'Etuve, 52

B-1000 Brussels

Permax 1 mg

1 mg

Tablet

Oral use

Belgium

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade, b22 |
| B-1020 Brussels |

EUROGENERICS N.V.

Heizel Esplanade, b22

B-1020 Brussels

Pergolide EG 0,05 mg

0,5 mg

Tablet

Oral use

Belgium

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade, b22 |
| B-1020 Brussels |

EUROGENERICS N.V.

Heizel Esplanade, b22

B-1020 Brussels

Pergolide EG 0,25 mg

0,26 mg

Tablet

Oral use

Belgium

| IVAX Pharmaceuticals s. r. o. |
| --- |
| Ostravská 29 |
| CZ-747 70 Opava 9 |

IVAX Pharmaceuticals s. r. o.

Ostravská 29

CZ-747 70 Opava 9

Pergolide IVAX Pharmaceuticals 1 mg

1 mg

Tablet

Oral use

Belgium

| IVAX Pharmaceuticals s. r. o. |
| --- |
| Ostravská 29 |
| CZ-747 70 Opava 9 |

IVAX Pharmaceuticals s. r. o.

Ostravská 29

CZ-747 70 Opava 9

Pergolide IVAX Pharmaceuticals 250 mcg

0,26 mg

Tablet

Oral use

Belgium

| IVAX Pharmaceuticals s. r. o. |
| --- |
| Ostravská 29 |
| CZ-747 70 Opava 9 |

IVAX Pharmaceuticals s. r. o.

Ostravská 29

CZ-747 70 Opava 9

Pergolide IVAX Pharmaceuticals 50 mcg

0,05 mg

Tablet

Oral use

Cyprus

| PHADISCO LTD |
| --- |
| P.O.Box 22173 |
| CY-1518 Lefkosia |

PHADISCO LTD

P.O.Box 22173

CY-1518 Lefkosia

Celance

0,05 mg

Tablet

Oral use

Cyprus

| PHADISCO LTD |
| --- |
| P.O.Box 22173 |
| CY-1518 Lefkosia |

PHADISCO LTD

P.O.Box 22173

CY-1518 Lefkosia

Celance

0,26 mg

Tablet

Oral use

Cyprus

| PHADISCO LTD |
| --- |
| P.O.Box 22173 |
| CY-1518 Lefkosia |

PHADISCO LTD

P.O.Box 22173

CY-1518 Lefkosia

Celance

1 mg

Tablet

Oral use

Czech Republic

| ELI LILLY |
| --- |
| Pobřežní 1A, building |
| CZ-186 00 Praha 8 |

ELI LILLY

Pobřežní 1A, building

CZ-186 00 Praha 8

Permax 0,05

0,05 mg

Tablet

Oral use

Czech Republic

| ELI LILLY |
| --- |
| Pobřežní 1A, building |
| CZ-186 00 Praha 8 |

ELI LILLY

Pobřežní 1A, building

CZ-186 00 Praha 8

Permax 0,26

0,26 mg

Tablet

Oral use

Czech Republic

| ELI LILLY |
| --- |
| Pobřežní 1A, building |
| CZ-186 00 Praha 8 |

ELI LILLY

Pobřežní 1A, building

CZ-186 00 Praha 8

PERMAX 1,0

1 mg

Tablet

Oral use

Czech Republic

| IVAX Pharmaceuticals ČR |
| --- |
| Opava-Komárov |
| Czech Republic |
| Contact is: Teva Pharmaceuticals ČR s. r. o. |
| Radlická 3185/1C |
| CZ-150 00 Praha 5 |

IVAX Pharmaceuticals ČR

Opava-Komárov

Czech Republic

Contact is: Teva Pharmaceuticals ČR s. r. o.

Radlická 3185/1C

CZ-150 00 Praha 5

Hizest 0,05 mg

0,05 mg

Tablet

Oral use

Czech Republic

| IVAX Pharmaceuticals ČR |
| --- |
| Opava-Komárov |
| Czech Republic |
| Contact is: Teva Pharmaceuticals ČR s. r. o. |
| Radlická 3185/1C |
| CZ-150 00 Praha 5 |

IVAX Pharmaceuticals ČR

Opava-Komárov

Czech Republic

Contact is: Teva Pharmaceuticals ČR s. r. o.

Radlická 3185/1C

CZ-150 00 Praha 5

Hizest 0,26 mg

0,26 mg

Tablet

Oral use

Czech Republic

| IVAX Pharmaceuticals ČR |
| --- |
| Opava-Komárov |
| Czech Republic |
| Contact is: Teva Pharmaceuticals ČR s. r. o. |
| Radlická 3185/1C |
| CZ-150 00 Praha 5 |

IVAX Pharmaceuticals ČR

Opava-Komárov

Czech Republic

Contact is: Teva Pharmaceuticals ČR s. r. o.

Radlická 3185/1C

CZ-150 00 Praha 5

Hizest 1 mg

1 mg

Tablet

Oral use

Denmark

| RATIOPHARM GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Pergolid ‘Ratiopharm’

0,25 mg

Tablet

Oral use

Denmark

| RATIOPHARM GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Pergolid ‘Ratiopharm’

1 mg

Tablet

Oral use

Denmark

| COPYFARM A/S |
| --- |
| Energivej 15 |
| DK-5260 Odense S |

COPYFARM A/S

Energivej 15

DK-5260 Odense S

Pergolid ‘Copyfarm’

0,05 mg

Tablet

Oral use

Denmark

| COPYFARM A/S |
| --- |
| Energivej 15 |
| DK-5260 Odense S |

COPYFARM A/S

Energivej 15

DK-5260 Odense S

Pergolid ‘Copyfarm’

0,25 mg

Tablet

Oral use

Denmark

| COPYFARM A/S |
| --- |
| Energivej 15 |
| DK-5260 Odense S |

COPYFARM A/S

Energivej 15

DK-5260 Odense S

Pergolid ‘Copyfarm’

1 mg

Tablet

Oral use

Estonia

| IVAX Pharmaceuticals s. r. o. |
| --- |
| Ostravská 28 |
| CZ-747 70 Opava-Komárov |

IVAX Pharmaceuticals s. r. o.

Ostravská 28

CZ-747 70 Opava-Komárov

Hizest 50 mcg

0,05 mg

Tablet

Oral use

Estonia

| IVAX Pharmaceuticals s. r. o. |
| --- |
| Ostravská 28 |
| CZ-747 70 Opava-Komárov |

IVAX Pharmaceuticals s. r. o.

Ostravská 28

CZ-747 70 Opava-Komárov

Hizest 250 mcg

0,25 mg

Tablet

Oral use

Estonia

| IVAX Pharmaceuticals s. r. o. |
| --- |
| Ostravská 28 |
| CZ-747 70 Opava-Komárov |

IVAX Pharmaceuticals s. r. o.

Ostravská 28

CZ-747 70 Opava-Komárov

Hizest 1 mg

1 mg

Tablet

Oral use

Estonia

| ELI LILLY Holding Limited |
| --- |
| Kingsclere Road |
| Basingstocke |
| Hampshire RG216XA |
| United Kingdom |

ELI LILLY Holding Limited

Kingsclere Road

Basingstocke

Hampshire RG216XA

United Kingdom

Permax

0,05 mg

Tablet

Oral use

Estonia

| ELI LILLY Holding Limited |
| --- |
| Kingsclere Road |
| Basingstocke |
| Hampshire RG216XA |
| United Kingdom |

ELI LILLY Holding Limited

Kingsclere Road

Basingstocke

Hampshire RG216XA

United Kingdom

Permax

0,25 mg

Tablet

Oral use

Estonia

| ELI LILLY Holding Limited |
| --- |
| Kingsclere Road |
| Basingstocke |
| Hampshire RG216XA |
| United Kingdom |

ELI LILLY Holding Limited

Kingsclere Road

Basingstocke

Hampshire RG216XA

United Kingdom

Permax

1 mg

Tablet

Oral use

Finland

| ELI LILLY Finland Oy |
| --- |
| Ab Rajatorpantie 41 C |
| FI-01641 Vantaa |

ELI LILLY Finland Oy

Ab Rajatorpantie 41 C

FI-01641 Vantaa

PERMAX

0,25 mg

Tablet

Oral use

Finland

| ELI LILLY Finland Oy |
| --- |
| Ab Rajatorpantie 41 C |
| FI-01641 Vantaa |

ELI LILLY Finland Oy

Ab Rajatorpantie 41 C

FI-01641 Vantaa

PERMAX

1 mg

Tablet

Oral use

Finland

| ELI LILLY Finland Oy |
| --- |
| Ab Rajatorpantie 41 C |
| FI-01641 Vantaa |

ELI LILLY Finland Oy

Ab Rajatorpantie 41 C

FI-01641 Vantaa

PERMAX

0,05 mg

Tablet

Oral use

France

| Lilly France SA |
| --- |
| 13, rue Pages |
| F-92158 Suresnes Cedex |

Lilly France SA

13, rue Pages

F-92158 Suresnes Cedex

Celance

0,05 mg

Tablet

Oral use

France

| Lilly France SA |
| --- |
| 13, rue Pages |
| F-92158 Suresnes Cedex |

Lilly France SA

13, rue Pages

F-92158 Suresnes Cedex

Celance

0,26 mg

Tablet

Oral use

France

| Lilly France SA |
| --- |
| 13, rue Pages |
| F-92158 Suresnes Cedex |

Lilly France SA

13, rue Pages

F-92158 Suresnes Cedex

Celance

1 mg

Tablet

Oral use

France

| Société TEVA CLASSICS |
| --- |
| Le pallatin 1, 1 cour du triangle |
| F-92936 Paris la Défence cedex |

Société TEVA CLASSICS

Le pallatin 1, 1 cour du triangle

F-92936 Paris la Défence cedex

Pergolide EG

0,5 mg

Tablet

Oral use

France

| Société TEVA CLASSICS |
| --- |
| Le pallatin 1, 1 cour du triangle |
| F-92936 Paris la Défence cedex |

Société TEVA CLASSICS

Le pallatin 1, 1 cour du triangle

F-92936 Paris la Défence cedex

Pergolide EG

0,26 mg

Tablet

Oral use

France

| Bayer Schering Pharma |
| --- |
| ZI Roubaix Est, Rue de Touflers |
| F-59390 Lys-les-Lannoy |

Bayer Schering Pharma

ZI Roubaix Est, Rue de Touflers

F-59390 Lys-les-Lannoy

CELANCE

0,05 mg

Tablet

Oral use

France

| Bayer Schering Pharma |
| --- |
| ZI Roubaix Est, Rue de Touflers |
| F-59390 Lys-les-Lannoy |

Bayer Schering Pharma

ZI Roubaix Est, Rue de Touflers

F-59390 Lys-les-Lannoy

CELANCE

0,26 mg

Tablet

Oral use

France

| Bayer Schering Pharma |
| --- |
| ZI Roubaix Est, Rue de Touflers |
| F-59390 Lys-les-Lannoy |

Bayer Schering Pharma

ZI Roubaix Est, Rue de Touflers

F-59390 Lys-les-Lannoy

CELANCE

1 mg

Tablet

Oral use

Germany

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Pergolid dura 0,05 mg Tabletten

0,065 mg

Tablet

Oral use

Germany

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Pergolid dura 0,25 mg Tabletten

0,325 mg

Tablet

Oral use

Germany

| MERCK Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

MERCK Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Pergolid dura 1 mg Tabletten

1,3 mg

Tablet

Oral use

Germany

| LILLY Deutschland GmbH |
| --- |
| Saalburgstr. 153 |
| D-61350 Bad Homburg |

LILLY Deutschland GmbH

Saalburgstr. 153

D-61350 Bad Homburg

Parkotil 0,05

0,065 mg

Tablet

Oral use

Germany

| LILLY Deutschland GmbH |
| --- |
| Saalburgstr. 153 |
| D-61350 Bad Homburg |

LILLY Deutschland GmbH

Saalburgstr. 153

D-61350 Bad Homburg

Parkotil 0,26

0,326 mg

Tablet

Oral use

Germany

| LILLY Deutschland GmbH |
| --- |
| Saalburgstr. 153 |
| D-61350 Bad Homburg |

LILLY Deutschland GmbH

Saalburgstr. 153

D-61350 Bad Homburg

Parkotil 1,0

1,3 mg

Tablet

Oral use

Germany

| AbZ-PHARMA |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm, Germany |

AbZ-PHARMA

Graf-Arco-Str. 3

D-89079 Ulm, Germany

Pergolid AbZ 0,25 mg Tabletten

0,325 mg

Tablet

Oral use

Germany

| AbZ-PHARMA |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm, Germany |

AbZ-PHARMA

Graf-Arco-Str. 3

D-89079 Ulm, Germany

Pergolid AbZ 1 mg Tabletten

1,,.3 mg

Tablet

Oral use

Germany

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pergolid beta 0,05 mg Tabletten

0,0653 mg

Tablet

Oral use

Germany

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pergolid beta 0,25 mg Tabletten

0,326 mg

Tablet

Oral use

Germany

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pergolid beta 1 mg Tabletten

1,306 mg

Tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Pergolid Hexal 0,05mg Tabletten

0,0653 mg

Tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Pergolid Hexal 0,25mg Tabletten

0,326 mg

Tablet

Oral use

Germany

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Pergolid Hexal 1,0mg Tabletten

1,3 mg

Tablet

Oral use

Germany

| NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG |
| --- |
| Postfach 400455 |
| D-40244 Langenfeld |

NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG

Postfach 400455

D-40244 Langenfeld

Pergolid 0,05 mg

0,0655 mg

Tablet

Oral use

Germany

| NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG |
| --- |
| Postfach 400455 |
| D-40244 Langenfeld |

NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG

Postfach 400455

D-40244 Langenfeld

Pergolid 0,25 mg

0,3275 mg

Tablet

Oral use

Germany

| NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG |
| --- |
| Postfach 400455 |
| D-40244 Langenfeld |

NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG

Postfach 400455

D-40244 Langenfeld

Pergolid 1,0 mg

1,31 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Pergolid-TEVA 0,05 mg Tabletten

0,065 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

Pergolid-TEVA 0,25 mg Tabletten

0,325 mg

Tablet

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten, Germany |

TEVA Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten, Germany

Pergolid-TEVA 1 mg Tabletten

1,3 mg

Tablet

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Pergolid-ratiopharm 0,25 mg Tabletten

0,325 mg

Tablet

Oral use

Germany

| RATIOPHARM |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

RATIOPHARM

Graf-Arco-Straße 3

D-89079 Ulm

Pergolid-ratiopharm 1 mg Tabletten

1,3 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Pergolid Sandoz 0,05 mg Tabletten

0,0653 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Pergolid Sandoz 0,25 mg Tabletten

0,3264 mg

Tablet

Oral use

Germany

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Pergolid Sandoz 1 mg Tabletten

1,3056 mg

Tablet

Oral use

Greece

| PHARMASERV LILLY Α.Ε.Β.Ε. |
| --- |
| 15th km National Highway Athens-Lamia |
| P.O. BOX 51288 |
| GR-14564 Kifissia |

PHARMASERV LILLY Α.Ε.Β.Ε.

15th km National Highway Athens-Lamia

P.O. BOX 51288

GR-14564 Kifissia

ΣΕΛΑΝΣ

This trademark exists only in Greek

0,05 mg

Tablet

Oral use

Greece

| PHARMASERV LILLY Α.Ε.Β.Ε. |
| --- |
| 15th km National Highway Athens-Lamia |
| P.O. BOX 51288 |
| GR-14564 Kifissia |

PHARMASERV LILLY Α.Ε.Β.Ε.

15th km National Highway Athens-Lamia

P.O. BOX 51288

GR-14564 Kifissia

ΣΕΛΑΝΣ

0,26 mg

Tablet

Oral use

Greece

| PHARMASERV LILLY Α.Ε.Β.Ε. |
| --- |
| 15th km National Highway Athens-Lamia |
| P.O. BOX 51288 |
| GR-14564 Kifissia |

PHARMASERV LILLY Α.Ε.Β.Ε.

15th km National Highway Athens-Lamia

P.O. BOX 51288

GR-14564 Kifissia

ΣΕΛΑΝΣ

1 mg

Tablet

Oral use

Iceland

| DAC ehf., heildsala, Auðbrekku 3-5, eining 0202 |
| --- |
| IS-100 Kópavogur |

DAC ehf., heildsala, Auðbrekku 3-5, eining 0202

IS-100 Kópavogur

Permax (DAC)

0,35 mg

Tablet

Oral use

Ireland

| ELI LILLY & Company Limited |
| --- |
| Lilly House |
| Priestley Rd |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

ELI LILLY & Company Limited

Lilly House

Priestley Rd

Basingstoke

Hampshire RG24 9NL

United Kingdom

Celance

0,05 mg

Tablet

Oral use

Ireland

| ELI LILLY & Company Limited |
| --- |
| Lilly House |
| Priestley Rd |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

ELI LILLY & Company Limited

Lilly House

Priestley Rd

Basingstoke

Hampshire RG24 9NL

United Kingdom

Celance

0,26 mg

Tablet

Oral use

Ireland

| ELI LILLY & Company Limited |
| --- |
| Lilly House |
| Priestley Rd |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

ELI LILLY & Company Limited

Lilly House

Priestley Rd

Basingstoke

Hampshire RG24 9NL

United Kingdom

Celance

1 mg

Tablet

Oral use

Ireland

| McDERMOTT Laboratories Ltd T/A Gerard Laboratories |
| --- |
| 35/36 Baldoyle Industrial Estate |
| Grange Road |
| Dublin 13 |
| Ireland |

McDERMOTT Laboratories Ltd T/A Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Pergolide

0,05 mg

Tablet

Oral use

Ireland

| McDERMOTT Laboratories Ltd T/A Gerard Laboratories |
| --- |
| 35/36 Baldoyle Industrial Estate |
| Grange Road |
| Dublin 13 |
| Ireland |

McDERMOTT Laboratories Ltd T/A Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Pergolide

0,26 mg

Tablet

Oral use

Ireland

| McDERMOTT Laboratories Ltd T/A Gerard Laboratories |
| --- |
| 35/36 Baldoyle Industrial Estate |
| Grange Road |
| Dublin 13 |
| Ireland |

McDERMOTT Laboratories Ltd T/A Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Pergolide

1 mg

Tablet

Oral use

Italy

| ELI LILLY Italia SpA |
| --- |
| Via Gramsci, 731/733 |
| I-50019 Sesto Fiorentino (FI) |

ELI LILLY Italia SpA

Via Gramsci, 731/733

I-50019 Sesto Fiorentino (FI)

Nopar

0,05 mg

Tablet

Oral use

Italy

| ELI LILLY Italia SpA |
| --- |
| Via Gramsci, 731/733 |
| I-50019 Sesto Fiorentino (FI) |

ELI LILLY Italia SpA

Via Gramsci, 731/733

I-50019 Sesto Fiorentino (FI)

Nopar

0,26 mg

Tablet

Oral use

Italy

| ELI LILLY Italia SpA |
| --- |
| Via Gramsci, 731/733 |
| I-50019 Sesto Fiorentino (FI) |

ELI LILLY Italia SpA

Via Gramsci, 731/733

I-50019 Sesto Fiorentino (FI)

Nopar

1 mg

Tablet

Oral use

Italy

| EG SpA |
| --- |
| Via Domenico Scarlatti, 31 |
| I-20124 Milano |

EG SpA

Via Domenico Scarlatti, 31

I-20124 Milano

Pergolide EG

0,05 mg

Tablet

Oral use

Italy

| EG SpA |
| --- |
| Via Domenico Scarlatti, 31 |
| I-20124 Milano |

EG SpA

Via Domenico Scarlatti, 31

I-20124 Milano

Pergolide EG

0,05 mg + 0,25 mg

Tablet

Oral use

Italy

| EG SpA |
| --- |
| Via Domenico Scarlatti, 31 |
| I-20124 Milano |

EG SpA

Via Domenico Scarlatti, 31

I-20124 Milano

Pergolide EG

0,25 mg

Tablet

Oral use

Italy

| EG SpA |
| --- |
| Via Domenico Scarlatti, 31 |
| I-20124 Milano |

EG SpA

Via Domenico Scarlatti, 31

I-20124 Milano

Pergolide EG

1 mg

Tablet

Oral use

Italy

| TEVA Pharma Italia Srl |
| --- |
| Via G. Richard, 7 |
| I-20143 Milano |

TEVA Pharma Italia Srl

Via G. Richard, 7

I-20143 Milano

Pergolide TEVA

0,05 mg

Tablet

Oral use

Italy

| TEVA Pharma Italia Srl |
| --- |
| Via G. Richard, 7 |
| I-20143 Milano |

TEVA Pharma Italia Srl

Via G. Richard, 7

I-20143 Milano

Pergolide TEVA

0,25 mg

Tablet

Oral use

Italy

| TEVA Pharma Italia Srl |
| --- |
| Via G. Richard, 7 |
| I-20143 Milano |

TEVA Pharma Italia Srl

Via G. Richard, 7

I-20143 Milano

Pergolide TEVA

1 mg

Tablet

Oral use

Italy

| MERCK GENERICS Italia SpA |
| --- |
| Via Aquileia, 35 |
| I-20092 Cinisello Balsamo (MI) |

MERCK GENERICS Italia SpA

Via Aquileia, 35

I-20092 Cinisello Balsamo (MI)

Pergolide Merck Generics

0,05 mg

Tablet

Oral use

Italy

| MERCK GENERICS Italia SpA |
| --- |
| Via Aquileia, 35 |
| I-20092 Cinisello Balsamo (MI) |

MERCK GENERICS Italia SpA

Via Aquileia, 35

I-20092 Cinisello Balsamo (MI)

Pergolide Merck Generics

0,25 mg

Tablet

Oral use

Italy

| MERCK GENERICS Italia SpA |
| --- |
| Via Aquileia, 35 |
| I-20092 Cinisello Balsamo (MI) |

MERCK GENERICS Italia SpA

Via Aquileia, 35

I-20092 Cinisello Balsamo (MI)

Pergolide Merck Generics

1 mg

Tablet

Oral use

Luxembourg

| ELI LILLY BENELUX S.A. |
| --- |
| rue de l'Etuve, 52 |
| B-1000 Brussels |

ELI LILLY BENELUX S.A.

rue de l'Etuve, 52

B-1000 Brussels

Permax

0,05 mg

Tablet

Oral use

Luxembourg

| ELI LILLY BENELUX S.A. |
| --- |
| rue de l'Etuve, 52 |
| B-1000 Brussels |

ELI LILLY BENELUX S.A.

rue de l'Etuve, 52

B-1000 Brussels

Permax

0,26 mg

Tablet

Oral use

Luxembourg

| ELI LILLY BENELUX S.A. |
| --- |
| rue de l'Etuve, 52 |
| B-1000 Brussels |

ELI LILLY BENELUX S.A.

rue de l'Etuve, 52

B-1000 Brussels

Permax

1 mg

Tablet

Oral use

Malta

| PHADISCO LTD |
| --- |
| 185 Yiannou Kranidioti Avenue |
| CY-2235 Latsia |

PHADISCO LTD

185 Yiannou Kranidioti Avenue

CY-2235 Latsia

Celance

0,05 mg

Tablet

Oral use

Malta

| PHADISCO LTD |
| --- |
| 185 Yiannou Kranidioti Avenue |
| CY-2235 Latsia |

PHADISCO LTD

185 Yiannou Kranidioti Avenue

CY-2235 Latsia

Celance

0,26 mg

Tablet

Oral use

Malta

| PHADISCO LTD |
| --- |
| 185 Yiannou Kranidioti Avenue |
| CY-2235 Latsia |

PHADISCO LTD

185 Yiannou Kranidioti Avenue

CY-2235 Latsia

Celance

1 mg

Tablet

Oral use

Netherlands

| ELI LILLY Nederland BV |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nederland |

ELI LILLY Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

Permax 0,25

0,26 mg

Tablet

Oral use

Netherlands

| ELI LILLY Nederland BV |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nederland |

ELI LILLY Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

Permax 1,0

1.0 mg

Tablet

Oral use

Netherlands

| CENTRAFARM SERVICES B.V. |
| --- |
| Nieuwe Donk 9 |
| 4879 AC ETTEN-LEUR |
| Nederland |

CENTRAFARM SERVICES B.V.

Nieuwe Donk 9

4879 AC ETTEN-LEUR

Nederland

Pergolide CF 0,05 mg

0,05 mg

Tablet

Oral use

Netherlands

| CENTRAFARM SERVICES B.V. |
| --- |
| Nieuwe Donk 9 |
| 4879 AC ETTEN-LEUR |
| Nederland |

CENTRAFARM SERVICES B.V.

Nieuwe Donk 9

4879 AC ETTEN-LEUR

Nederland

Pergolide CF 0,26 mg

0,26 mg

Tablet

Oral use

Netherlands

| CENTRAFARM SERVICES B.V. |
| --- |
| Nieuwe Donk 9 |
| 4879 AC ETTEN-LEUR |
| Nederland |

CENTRAFARM SERVICES B.V.

Nieuwe Donk 9

4879 AC ETTEN-LEUR

Nederland

Pergolide CF 1,0 mg

1.0 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide 0,05 mg

0,05 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide 0,26 mg

0,26 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide 1,0 mg

1,0 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide start pakket combination therapy

0,05 mg + 0,26 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide start pakket mono -therapy

0,05 mg + 0,26 mg

Tablet

Oral use

Netherlands

| RATIOPHARM Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

RATIOPHARM Nederland BV

Ronde Tocht 11

1507 CC Zaandam

Nederland

Pergolide Ratiopharm 0,25

0,26 mg

Tablet

Oral use

Netherlands

| RATIOPHARM Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

RATIOPHARM Nederland BV

Ronde Tocht 11

1507 CC Zaandam

Nederland

Pergolide Ratiopharm 1

1,0 mg

Tablet

Oral use

Netherlands

| RATIOPHARM Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

RATIOPHARM Nederland BV

Ronde Tocht 11

1507 CC Zaandam

Nederland

Pergolide Ratiopharm 0,05 mg

0,05 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide Sandoz 0,05 mg

0,05 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide Sandoz 0,26 mg

0,26 mg

Tablet

Oral use

Netherlands

| SANDOZ B.V. |
| --- |
| Veluwezoon 22 |
| 1327 AH ALMERE |
| Nederland |

SANDOZ B.V.

Veluwezoon 22

1327 AH ALMERE

Nederland

Pergolide Sandoz 1,0 mg

1,0 mg

Tablet

Oral use

Netherlands

| PHARMACHEMIE B.V. |
| --- |
| Swensweg 5 |
| Haarlem |
| Nederland |

PHARMACHEMIE B.V.

Swensweg 5

Haarlem

Nederland

Pergolide 0,05 PCH

0,05 mg

Tablet

Oral use

Netherlands

| PHARMACHEMIE B.V. |
| --- |
| Swensweg 5 |
| Haarlem |
| Nederland |

PHARMACHEMIE B.V.

Swensweg 5

Haarlem

Nederland

Pergolide 0,26 PCH

0,26 mg

Tablet

Oral use

Netherlands

| PHARMACHEMIE B.V. |
| --- |
| Swensweg 5 |
| Haarlem |
| Nederland |

PHARMACHEMIE B.V.

Swensweg 5

Haarlem

Nederland

Pergolide 1 PCH

1,0 mg

Tablet

Oral use

Netherlands

| APOTHECON B.V. |
| --- |
| Nijverheidsweg 3 |
| 3771 ME Barneveld |
| Nederland |

APOTHECON B.V.

Nijverheidsweg 3

3771 ME Barneveld

Nederland

Pergolide 0,05

0,05 mg

Tablet

Oral use

Netherlands

| APOTHECON B.V. |
| --- |
| Nijverheidsweg 3 |
| 3771 ME Barneveld |
| Nederland |

APOTHECON B.V.

Nijverheidsweg 3

3771 ME Barneveld

Nederland

Pegolide 0,25

0,26 mg

Tablet

Oral use

Netherlands

| APOTHECON B.V. |
| --- |
| Nijverheidsweg 3 |
| 3771 ME Barneveld |
| Nederland |

APOTHECON B.V.

Nijverheidsweg 3

3771 ME Barneveld

Nederland

Pergolide 1,0

1,0 mg

Tablet

Oral use

Netherlands

| IVAX Farma B.V. |
| --- |
| Tolnasingel 3 |
| 2411 PV Bodegraven |
| Nederland |

IVAX Farma B.V.

Tolnasingel 3

2411 PV Bodegraven

Nederland

Pergolide 0,25

0,26 mg

Tablet

Oral use

Netherlands

| IVAX Farma B.V. |
| --- |
| Tolnasingel 3 |
| 2411 PV Bodegraven |
| Nederland |

IVAX Farma B.V.

Tolnasingel 3

2411 PV Bodegraven

Nederland

Pergolide 1,0

1,0 mg

Tablet

Oral use

Netherlands

| IVAX Farma B.V. |
| --- |
| Tolnasingel 3 |
| 2411 PV Bodegraven |
| Nederland |

IVAX Farma B.V.

Tolnasingel 3

2411 PV Bodegraven

Nederland

Pergolide 0,05

0,05 mg

Tablet

Oral use

Netherlands

| MERCK GENERICS B.V. |
| --- |
| Dieselweg 26 |
| 3752 LB Bunschoten |
| Nederland |

MERCK GENERICS B.V.

Dieselweg 26

3752 LB Bunschoten

Nederland

Pergolide Merck 0,05 mg

0,05 mg

Tablet

Oral use

Netherlands

| MERCK GENERICS B.V. |
| --- |
| Dieselweg 26 |
| 3752 LB Bunschoten |
| Nederland |

MERCK GENERICS B.V.

Dieselweg 26

3752 LB Bunschoten

Nederland

Pergolide Merck 0,26 mg

0,26 mg

Tablet

Oral use

Netherlands

| MERCK GENERICS B.V. |
| --- |
| Dieselweg 26 |
| 3752 LB Bunschoten |
| Nederland |

MERCK GENERICS B.V.

Dieselweg 26

3752 LB Bunschoten

Nederland

Pergolide Merck 1,0 mg

1,0 mg

Tablet

Oral use

Poland

| IVAX Pharmaceuticals s.r.o. |
| --- |
| Ostravska 28 |
| CZ-74770 Opava-Komarov |

IVAX Pharmaceuticals s.r.o.

Ostravska 28

CZ-74770 Opava-Komarov

Hizest

0,05 mg

Tablet

Oral use

Poland

| IVAX Pharmaceuticals s.r.o. |
| --- |
| Ostravska 28 |
| CZ-74770 Opava-Komarov |

IVAX Pharmaceuticals s.r.o.

Ostravska 28

CZ-74770 Opava-Komarov

Hizest

0,25 mg

Tablet

Oral use

Poland

| IVAX Pharmaceuticals s.r.o. |
| --- |
| Ostravska 28 |
| CZ-74770 Opava-Komarov |

IVAX Pharmaceuticals s.r.o.

Ostravska 28

CZ-74770 Opava-Komarov

Hizest

1 mg

Tablet

Oral use

Portugal

| LILLY Portugal |
| --- |
| Produtos Farmacêuticos |
| Lda. Rua Dr. António Loureiro Borges, 1 |
| Piso 1 - Arquiparque - Miraflores |
| P-1499-016 Algés |

LILLY Portugal

Produtos Farmacêuticos

Lda. Rua Dr. António Loureiro Borges, 1

Piso 1 - Arquiparque - Miraflores

P-1499-016 Algés

Permax

1 mg

Tablet

Oral use

Portugal

| LILLY Portugal |
| --- |
| Produtos Farmacêuticos |
| Lda. Rua Dr. António Loureiro Borges, 1 |
| Piso 1 - Arquiparque - Miraflores |
| P-1499-016 Algés |

LILLY Portugal

Produtos Farmacêuticos

Lda. Rua Dr. António Loureiro Borges, 1

Piso 1 - Arquiparque - Miraflores

P-1499-016 Algés

Permax

0,05 mg

Tablet

Oral use

Portugal

| LILLY Portugal |
| --- |
| Produtos Farmacêuticos |
| Lda. Rua Dr. António Loureiro Borges, 1 |
| Piso 1 - Arquiparque - Miraflores |
| P-1499-016 Algés |

LILLY Portugal

Produtos Farmacêuticos

Lda. Rua Dr. António Loureiro Borges, 1

Piso 1 - Arquiparque - Miraflores

P-1499-016 Algés

Permax

0,26 mg

Tablet

Oral use

Portugal

| Ratiopharm |
| --- |
| Comércio e Indústria de Produtos Farmacêuticos |
| Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso |
| P-2790-143 Carnaxide |

Ratiopharm

Comércio e Indústria de Produtos Farmacêuticos

Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso

P-2790-143 Carnaxide

Pergolida ratiopharm 0,25 mg comprimidos

0,26 mg

Tablet

Oral use

Portugal

| Ratiopharm |
| --- |
| Comércio e Indústria de Produtos Farmacêuticos |
| Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso |
| P-2790-143 Carnaxide |

Ratiopharm

Comércio e Indústria de Produtos Farmacêuticos

Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso

P-2790-143 Carnaxide

Pergolida ratiopharm 1 mg comprimidos

1 mg

Tablet

Oral use

Portugal

| TEVA Pharma |
| --- |
| Produtos Farmacêuticos |
| Lda. Empreendimento Lagoas Park - Edifício 1-3o |
| P-2740-264 Porto Salvo |

TEVA Pharma

Produtos Farmacêuticos

Lda. Empreendimento Lagoas Park - Edifício 1-3o

P-2740-264 Porto Salvo

Pergolida Teva 1 mg comprimidos

1 mg

Tablet

Oral use

Portugal

| TEVA Pharma |
| --- |
| Produtos Farmacêuticos |
| Lda. Empreendimento Lagoas Park - Edifício 1-3o |
| P-2740-264 Porto Salvo |

TEVA Pharma

Produtos Farmacêuticos

Lda. Empreendimento Lagoas Park - Edifício 1-3o

P-2740-264 Porto Salvo

Pergolida Teva 0,05 mg comprimidos

0,05 mg

Tablet

Oral use

Portugal

| TEVA Pharma |
| --- |
| Produtos Farmacêuticos |
| Lda. Empreendimento Lagoas Park - Edifício 1-3o |
| P-2740-264 Porto Salvo |

TEVA Pharma

Produtos Farmacêuticos

Lda. Empreendimento Lagoas Park - Edifício 1-3o

P-2740-264 Porto Salvo

Pergolida Teva 0,25 mg comprimidos

0,26 mg

Tablet

Oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura - Edifício 4 - Quinta da Beloura |
| P-2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura - Edifício 4 - Quinta da Beloura

P-2710-444 Sintra

Pergolida Generis

0,05 mg

Tablet

Oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura - Edifício 4 - Quinta da Beloura |
| P-2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura - Edifício 4 - Quinta da Beloura

P-2710-444 Sintra

Pergolida Generis

0,26 mg

Tablet

Oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura - Edifício 4 - Quinta da Beloura |
| P-2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura - Edifício 4 - Quinta da Beloura

P-2710-444 Sintra

Pergolida Generis

1 mg

Tablet

Oral use

Portugal

| MERCK Genéricos |
| --- |
| Produtos Farmacêuticos |
| Lda. Rua Alfredo da Silva, 3 C - 4o |
| P-1300-040 Lisboa |

MERCK Genéricos

Produtos Farmacêuticos

Lda. Rua Alfredo da Silva, 3 C - 4o

P-1300-040 Lisboa

Pergolida Merck Genéricos 0,05 mg comprimidos

0,05 mg

Tablet

Oral use

Portugal

| MERCK Genéricos |
| --- |
| Produtos Farmacêuticos |
| Lda. Rua Alfredo da Silva, 3 C - 4o |
| P-1300-040 Lisboa |

MERCK Genéricos

Produtos Farmacêuticos

Lda. Rua Alfredo da Silva, 3 C - 4o

P-1300-040 Lisboa

Pergolida Merck Genéricos 0,25 mg comprimidos

0,26 mg

Tablet

Oral use

Portugal

| MERCK Genéricos |
| --- |
| Produtos Farmacêuticos |
| Lda. Rua Alfredo da Silva, 3 C - 4o |
| P-1300-040 Lisboa |

MERCK Genéricos

Produtos Farmacêuticos

Lda. Rua Alfredo da Silva, 3 C - 4o

P-1300-040 Lisboa

Pergolida Merck Genéricos 1mg comprimidos

1 mg

Tablet

Oral use

Spain

| LYLLY SA, |
| --- |
| Avda de la Industria, 30 |
| Alcobendas |
| Spain |

LYLLY SA,

Avda de la Industria, 30

Alcobendas

Spain

Pharken 1 mg comprimidos

1 mg

Film-coated tablet

Oral use

Spain

| LYLLY SA, |
| --- |
| Avda de la Industria, 30 |
| Alcobendas |
| Spain |

LYLLY SA,

Avda de la Industria, 30

Alcobendas

Spain

Pharken 0,05 mg comprimidos

0,05 mg

Film-coated tablet

Oral use

Spain

| LYLLY SA, |
| --- |
| Avda de la Industria, 30 |
| Alcobendas |
| Spain |

LYLLY SA,

Avda de la Industria, 30

Alcobendas

Spain

Pharken 0,25 mg comprimidos

0,25 mg

Film-coated tablet

Oral use

Spain

| Ratiopharm España SA |
| --- |
| Avda. Burgos, 160-5a planta |
| E-28036, Madrid |

Ratiopharm España SA

Avda. Burgos, 160-5a planta

E-28036, Madrid

Pergolida Ratiopharm 1 mg comprimidos

1 mg

Tablet

Oral use

Spain

| Ratiopharm España SA |
| --- |
| Avda. Burgos, 160-5a planta |
| E-28036, Madrid |

Ratiopharm España SA

Avda. Burgos, 160-5a planta

E-28036, Madrid

Pergolida Ratiopharm 0,25 mg comprimidos

0,25 mg

Tablet

Oral use

Spain

| TEVA Genericos Española SA |
| --- |
| German El Bueno, 33, Edificio Britania 4o, Izquierda |
| P-28003 Madrid |

TEVA Genericos Española SA

German El Bueno, 33, Edificio Britania 4o, Izquierda

P-28003 Madrid

Pergolida Teva 0,25 mg comprimidos

0,25 mg

Tablet

Oral use

Spain

| TEVA Genericos Española SA |
| --- |
| German El Bueno, 33, Edificio Britania 4o, Izquierda |
| P-28003 Madrid |

TEVA Genericos Española SA

German El Bueno, 33, Edificio Britania 4o, Izquierda

P-28003 Madrid

Pergolida Teva 0,05 mg comprimidos

0,05 mg

Tablet

Oral use

Spain

| TEVA Genericos Española SA |
| --- |
| German El Bueno, 33, Edificio Britania 4o, Izquierda |
| P-28003 Madrid |

TEVA Genericos Española SA

German El Bueno, 33, Edificio Britania 4o, Izquierda

P-28003 Madrid

Pergolida Teva 1 mg comprimidos

1 mg

Tablet

Oral use

United Kingdom

| ELI LILLY & Company Limited |
| --- |
| Lilly House |
| Priestley Rd |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

ELI LILLY & Company Limited

Lilly House

Priestley Rd

Basingstoke

Hampshire RG24 9NL

United Kingdom

Celance 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| ELI LILLY & Company Limited |
| --- |
| Lilly House |
| Priestley Rd |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

ELI LILLY & Company Limited

Lilly House

Priestley Rd

Basingstoke

Hampshire RG24 9NL

United Kingdom

Celance 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| ELI LILLY & Company Limited |
| --- |
| Lilly House |
| Priestley Rd |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

ELI LILLY & Company Limited

Lilly House

Priestley Rd

Basingstoke

Hampshire RG24 9NL

United Kingdom

Celance 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| BETAPHARM Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

BETAPHARM Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| DR REDDY'S Laboratories (UK) Limited |
| --- |
| 6 Riverview Road |
| Beverley |
| East Yorkshire HU17 0LD |
| United Kingdom |

DR REDDY'S Laboratories (UK) Limited

6 Riverview Road

Beverley

East Yorkshire HU17 0LD

United Kingdom

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| DR REDDY'S Laboratories (UK) Limited |
| --- |
| 6 Riverview Road |
| Beverley |
| East Yorkshire HU17 0LD |
| United Kingdom |

DR REDDY'S Laboratories (UK) Limited

6 Riverview Road

Beverley

East Yorkshire HU17 0LD

United Kingdom

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| DR REDDY'S Laboratories (UK) Limited |
| --- |
| 6 Riverview Road |
| Beverley |
| East Yorkshire HU17 0LD |
| United Kingdom |

DR REDDY'S Laboratories (UK) Limited

6 Riverview Road

Beverley

East Yorkshire HU17 0LD

United Kingdom

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| HEXAL AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| NORTON Healthcare Limited |
| --- |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

NORTON Healthcare Limited

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| NORTON Healthcare Limited |
| --- |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

NORTON Healthcare Limited

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| NORTON Healthcare Limited |
| --- |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

NORTON Healthcare Limited

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| GENERICS (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Herts EN6 1TL |
| United Kingdom |

GENERICS (UK) Limited

Station Close

Potters Bar

Herts EN6 1TL

United Kingdom

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| GENERICS (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Herts EN6 1TL |
| United Kingdom |

GENERICS (UK) Limited

Station Close

Potters Bar

Herts EN6 1TL

United Kingdom

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| GENERICS (UK) Limited |
| --- |
| Station Close |
| Potters Bar |
| Herts EN6 1TL |
| United Kingdom |

GENERICS (UK) Limited

Station Close

Potters Bar

Herts EN6 1TL

United Kingdom

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| SANDOZ Limited |
| --- |
| Woolmer Way |
| Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ Limited

Woolmer Way

Borden

Hampshire GU35 9QE

United Kingdom

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| SANDOZ Limited |
| --- |
| Woolmer Way |
| Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ Limited

Woolmer Way

Borden

Hampshire GU35 9QE

United Kingdom

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| SANDOZ Limited |
| --- |
| Woolmer Way |
| Borden |
| Hampshire GU35 9QE |
| United Kingdom |

SANDOZ Limited

Woolmer Way

Borden

Hampshire GU35 9QE

United Kingdom

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

United Kingdom

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Pergolide 50 mcg tablet

0,05 mg

Tablet

Oral use

United Kingdom

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Pergolide 250 mcg tablet

0,26 mg

Tablet

Oral use

United Kingdom

| SANDOZ Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 1 |
| D-83607 Holzkirchen |

SANDOZ Pharmaceuticals GmbH

Raiffeisenstr. 1

D-83607 Holzkirchen

Pergolide 1 000 mcg tablet

1 mg

Tablet

Oral use

---

ANNEX IV

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Stada Arzneimittel GmbH |
| Heiligenstädter Straße 52/2/8 |
| A-1190 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Stada Arzneimittel GmbH

Heiligenstädter Straße 52/2/8

A-1190 Wien

Floxacin 400 mg — Filmtabletten

400 mg

Film-coated tablet

Oral use

Austria

| Merck Sharp & Dohme GmbH |
| --- |
| Donau-City-Straße 6 |
| A-1220 Wien |

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Norfloxacin ‘MSD’ — Filmtabletten

400 mg

Film-coated tablet

Oral use

Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| A-1140 Wien |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Norfloxacin ‘ratiopharm’ — 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Norfloxacin Sandoz — 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Austria

| Merck Sharp & Dohme GmbH |
| --- |
| Donau-City-Straße 6 |
| A-1220 Wien |

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Zoroxin — Filmtabletten

400 mg

Film-coated tablet

Oral use

Belgium

| Merck, Sharp et Dohme |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck, Sharp et Dohme

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Zoroxin

400 mg

Tablet

Oral use

Belgium

| Docpharma N.V |
| --- |
| Ambachtenlaan 13H |
| B-3001 Heverlee |

Docpharma N.V

Ambachtenlaan 13H

B-3001 Heverlee

Docnorfloxa (ex: Floxolone)

400 mg

Film-coated tablet

Oral use

Belgium

| Socobom N.V |
| --- |
| Louizalaan 149 B24 |
| B-1050 Brussel |

Socobom N.V

Louizalaan 149 B24

B-1050 Brussel

Floxolone 400 mg

400 mg

Film-coated tablet

Oral use

Belgium

| Ratiopharm Belgium S.A |
| --- |
| Rue St-Lambert, 141 |
| B-1200 Bruxelles |

Ratiopharm Belgium S.A

Rue St-Lambert, 141

B-1200 Bruxelles

Norfloxacin — Ratiopharm 400

400 mg

Tablet

Oral use

Belgium

| Eurogenerics |
| --- |
| Heizel Esplanade B22 |
| B-1020 Brussel |

Eurogenerics

Heizel Esplanade B22

B-1020 Brussel

Norfloxacine EG

400 mg

Film-coated tablet

Oral use

Belgium

| Teva Generics Belgium NV |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

Teva Generics Belgium NV

Laarstraat 16

B-2610 Wilrijk

Norfloxacine Teva 400 mg

400 mg

Coated tablets

Oral use

Bulgaria

| Krka, d.d.Novo Mesto |
| --- |
| Smarjeka cesta 6 |
| SLO-8501 Novo mesto |

Krka, d.d.Novo Mesto

Smarjeka cesta 6

SLO-8501 Novo mesto

Nolicin

400 mg

Film-coated tablet

Oral use

Bulgaria

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

NorfloHexal

400 mg

Film-coated tablet

Oral use

Cyprus

| Merck Sharp & Dohme BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

Noroxin

400 mg

Tablet

Oral use

Cyprus

| Medochemie Ltd |
| --- |
| P.O Box 51409 |
| CY-Lemesos |

Medochemie Ltd

P.O Box 51409

CY-Lemesos

Gyrablock

400 mg

Tablet

Oral use

Cyprus

| Remedica Ltd |
| --- |
| P.O Box 51706 |
| CY-Lemesos |

Remedica Ltd

P.O Box 51706

CY-Lemesos

Trizolin

400 mg

Tablet

Oral use

Czech Republic

| Medochemie Ltd, Limassol |
| --- |
| Constantinoupoleos St. 1-10 |
| P.O.Box 51409 |
| CY-3505 Limassol |

Medochemie Ltd, Limassol

Constantinoupoleos St. 1-10

P.O.Box 51409

CY-3505 Limassol

Gyrablock 400

400 mg

Film-coated tablet

Oral use

Czech Republic

| Krka d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

Krka d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

Nolicin

400 mg

Coated tablet

Oral use

Czech Republic

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89070 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89070 Ulm

Norfloxacin-Ratiopharm 400 mg

400 mg

Film-coated tablet

Oral use

Denmark

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann Straße 5 |
| D-27472, Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann Straße 5

D-27472, Cuxhaven

Norflocux

400 mg

Film-coated tablet

Oral

Estonia

| Krka d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

Krka d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

Nolicin

400 mg

Tablet

Oral use

Finland

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Norfloxacin Sandoz

200 mg

Film-coated tablet

Oral use

Finland

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Norfloxacin Sandoz

400 mg

Film-coated tablet

Oral use

Finland

| Ratiopharm Oy |
| --- |
| Vitikka 1 F |
| P.O Box 67 |
| FI-02630 Espoo |

Ratiopharm Oy

Vitikka 1 F

P.O Box 67

FI-02630 Espoo

Norfloxacin-Ratiopharm

400 mg

Film-coated tablet

Oral use

France

| Arrow Génériques |
| --- |
| 26, av. Tony Garnier |
| F-69007 Lyon |

Arrow Génériques

26, av. Tony Garnier

F-69007 Lyon

Norfloxacine Arrow

400 mg

Tablet

Oral use

France

| Biogaran |
| --- |
| 15, Bd Charles de Gaulle |
| F-92700 Colombes |

Biogaran

15, Bd Charles de Gaulle

F-92700 Colombes

Norfloxacine Biogaran

400 mg

Tablet

Oral use

France

| EG Labo |
| --- |
| ‘Le Quintet’ — bâtiment A |
| 12, rue Danjou |
| F-92517 Boulogne Billancourt Cedex |

EG Labo

‘Le Quintet’ — bâtiment A

12, rue Danjou

F-92517 Boulogne Billancourt Cedex

Norfloxacine EG

400 mg

Tablet

Oral use

France

| Ivax Pharmaceuticals SAS |
| --- |
| 1, cour du triangle |
| Immeuble palatin 1 |
| F-92936 Paris la Défense cedex |

Ivax Pharmaceuticals SAS

1, cour du triangle

Immeuble palatin 1

F-92936 Paris la Défense cedex

Norfloxacine Ivax

400 mg

Tablet

Oral use

France

| Merck Génériques |
| --- |
| 34, rue Saint-Romain |
| F-69359 Lyon Cedex 08 |

Merck Génériques

34, rue Saint-Romain

F-69359 Lyon Cedex 08

Norfloxacine Merck

400 mg

Tablet

Oral use

France

| Laboratoire Qualimed |
| --- |
| 34, rue Saint-Romain |
| F-69008 Lyon |

Laboratoire Qualimed

34, rue Saint-Romain

F-69008 Lyon

Norfloxacine Qualimed

400 mg

Tablet

Oral use

France

| Laboratoire RPG |
| --- |
| 4, place Louis Armand |
| F-75012 Paris |

Laboratoire RPG

4, place Louis Armand

F-75012 Paris

Norfloxacine Ranbaxy

400 mg

Tablet

Oral use

France

| Ratiopharm GmbH |
| --- |
| Graf Arco Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf Arco Straße 3

D-89079 Ulm

Norfloxacine Ratiopharm

400 mg

Tablet

Oral use

France

| Sandoz |
| --- |
| 49, avenue Georges Pompidou |
| F-92300 Levallois-Perret |

Sandoz

49, avenue Georges Pompidou

F-92300 Levallois-Perret

Norfloxacine Sandoz

400 mg

Tablet

Oral use

France

| Socitété Teva Classics |
| --- |
| Le Palatin 1 |
| 1, cour du Triangle |
| F-92936 Paris la Défense Cedex |

Socitété Teva Classics

Le Palatin 1

1, cour du Triangle

F-92936 Paris la Défense Cedex

Norfloxacine Teva

400 mg

Tablet

Oral use

France

| Sanofi Aventis France |
| --- |
| 1/13, Bd Romain Rolland |
| F-75014 Paris |

Sanofi Aventis France

1/13, Bd Romain Rolland

F-75014 Paris

Norfloxacine Winthrop

400 mg

Tablet

Oral use

France

| Merck Sharp — Dohme Chibret |
| --- |
| 3, avenue Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp — Dohme Chibret

3, avenue Hoche

F-75114 Paris Cedex 08

Noroxine

400 mg

Tablet

Oral use

Germany

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Norflox-1A Pharma

400 mg

Film-coated tablet

Oral use

Germany

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Norfloxacin AbZ 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Germany

| Aliud Pharma GmbH & Co.KG |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co.KG

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Norfloxacin AL 400 mg

400 mg

Film-coated tablet

Oral use

Germany

| Apogepha Arzneimittel GmbH |
| --- |
| Kyffhäuserstr. 27 |
| D-01309 Dresden |

Apogepha Arzneimittel GmbH

Kyffhäuserstr. 27

D-01309 Dresden

Bactracid

400 mg

Film-coated tablet

Oral use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Norflox-CT 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Germany

| Heumann Pharma GmbH & Co.Generica.KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |

Heumann Pharma GmbH & Co.Generica.KG

Südwestpark 50

D-90449 Nürnberg

Norfloxacin Heumann 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal AG

Industriestr. 25

D-83607 Holzkirchen

Norflohexal 400mg

400 mg

Film-coated tablet

Oral use

Germany

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Norfloxacin-ratiopharm 400 mg

400 mg

Film-coated tablet

Oral use

Germany

| Ruhrpharm AG |
| --- |
| Heidsieker Heide 114 |
| D-33739 Bielefeld |

Ruhrpharm AG

Heidsieker Heide 114

D-33739 Bielefeld

Norfluxx

400 mg

Film-coated tablet

Oral use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Norflox-Sandoz 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Norflox-Sandoz 400 mg

400 mg

Film-coated tablet

Oral use

Germany

| Schwarz Pharma Deutschland GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| D-40789 Monheim |

Schwarz Pharma Deutschland GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Firin

400 mg

Film-coated tablet

Oral use

Germany

| Stada Arzneimittel AG |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Norfloxa Stadapharm 400 mg

400 mg

Film-coated tablet

Oral use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Norfloxacin Stada 400 mg

400 mg

Film-coated tablet

Oral use

Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Norflosal

400 mg

Film-coated tablet

Oral use

Germany

| Teofarma S.R.L |
| --- |
| Via F.Iii Cervi 8 |
| I-27010 Valle Salimbene (PV) |

Teofarma S.R.L

Via F.Iii Cervi 8

I-27010 Valle Salimbene (PV)

Barazan

400 mg

Film-coated tablet

Oral use

Germany

| Uropharm AG |
| --- |
| Erfurtstr. 64 |
| D-53125 Bonn |

Uropharm AG

Erfurtstr. 64

D-53125 Bonn

Norflox-Uropharm 400 mg

400 mg

Film-coated tablet

Oral use

Greece

| Anfarm Hellas A.E |
| --- |
| K. Paleologou & Perikleous 27, |
| GR-15232 Halandri |

Anfarm Hellas A.E

K. Paleologou & Perikleous 27,

GR-15232 Halandri

Fluseminal

400 mg

Film-coated tablet

Oral use

Greece

| Rafarm Aebe |
| --- |
| Korinthou 12, |
| GR-15451 N. Psychiko |

Rafarm Aebe

Korinthou 12,

GR-15451 N. Psychiko

Pistofil

400 mg

Coated tablet

Oral use

Greece

| Vianex S.A |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythrea |

Vianex S.A

Tatoiou Street

GR-14671 Nea Erythrea

Norocin

400 mg

Film-coated tablet

Oral use

Greece

| Bros Epe |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia |
| Greece |

Bros Epe

Avgis & Gallinis 15

N. Kifissia

Greece

Constilax

400 mg

Coated tablet

Oral use

Greece

| Faran Abee |
| --- |
| Production and Trading Medicines |
| Averof 19A |
| GR-10433 Athens |

Faran Abee

Production and Trading Medicines

Averof 19A

GR-10433 Athens

Sofasin

400 mg

Film-coated tablet

Oral use

Greece

| Xrispa Alpha Farmaceuticals S.A |
| --- |
| 16th Km Marathonos Avenue |
| GR-15344 Pallini |

Xrispa Alpha Farmaceuticals S.A

16th Km Marathonos Avenue

GR-15344 Pallini

Alenbit

400 mg

Coated tablet

Oral use

Greece

| Vilco S.A |
| --- |
| Pefkon Street 121 |
| GR-14122 N. Irakleion |

Vilco S.A

Pefkon Street 121

GR-14122 N. Irakleion

Setanol

400 mg

Coated tablet

Oral use

Greece

| Medicrom S.A |
| --- |
| 6 Km Markopoulo-Koropi Avenue |
| GR-19003 Markopoulo Mesogeion |

Medicrom S.A

6 Km Markopoulo-Koropi Avenue

GR-19003 Markopoulo Mesogeion

Steinaclox-Medichrom

400 mg

Capsule

Oral use

Greece

| Genepharm A.E |
| --- |
| 18th Km Marathonos Avenue, Pallini |
| GR-15351 Attikis |

Genepharm A.E

18th Km Marathonos Avenue, Pallini

GR-15351 Attikis

Grenis

400 mg

Coated tablet

Oral use

Greece

| Biospray Abee |
| --- |
| 18th Km Marathonos Avenue |
| GR-15344 Pallini |

Biospray Abee

18th Km Marathonos Avenue

GR-15344 Pallini

Sinobid

400 mg

Film-coated tablet

Oral use

Greece

| Specifar Abee |
| --- |
| 28th October Street No 1 |
| GR-12351 Agia Barbara |

Specifar Abee

28th October Street No 1

GR-12351 Agia Barbara

Urospes-N

400 mg

Film-coated tablet

Oral use

Greece

| Coup Abee |
| --- |
| Agias Varvaras 53-55 |
| Dafni |
| GR-17235 Athens |

Coup Abee

Agias Varvaras 53-55

Dafni

GR-17235 Athens

Lorcamin

400 mg

Coated tablet

Oral use

Greece

| Viofar Epe |
| --- |
| Ethnikis Antistaseos & Trifyllias |
| GR-13671 Aharnai |

Viofar Epe

Ethnikis Antistaseos & Trifyllias

GR-13671 Aharnai

Vetamol

400 mg

Film-coated tablet

Oral use

Greece

| Sandoz GmbH, Kundl, Austria |
| --- |
| Biochemiestrasse 10 |
| A-6520, Kundl |
| Austria |

Sandoz GmbH, Kundl, Austria

Biochemiestrasse 10

A-6520, Kundl

Austria

Urobacid

400 mg

Film-coated tablet

Oral use

Hungary

| Krka |
| --- |
| Magyarország Kereskedelmi Kft |
| Pacsirtamező u. 5 |
| H-1036 Budapest |

Krka

Magyarország Kereskedelmi Kft

Pacsirtamező u. 5

H-1036 Budapest

Nolicin

400 mg

Tablet

Oral use

Hungary

| Krka |
| --- |
| Magyarország Kereskedelmi Kft |
| Pacsirtamező u. 5 |
| H-1036 Budapest |

Krka

Magyarország Kereskedelmi Kft

Pacsirtamező u. 5

H-1036 Budapest

Nolicin-S

400 mg

Film-coated tablet

Oral use

Hungary

| AC Helcor Hungary Kft |
| --- |
| Madarász Viktor u. 27 |
| H-1131 Budapest |

AC Helcor Hungary Kft

Madarász Viktor u. 27

H-1131 Budapest

Norfloxacin-Helcor

400 mg

Film-coated tablet

Oral use

Hungary

| Ratiopharm Hungária Kft. |
| --- |
| Uzsoki u. 36/a |
| H-1145 Budapest |

Ratiopharm Hungária Kft.

Uzsoki u. 36/a

H-1145 Budapest

Norfloxacin-Ratiopharm

400 mg

Film-coated tablet

Oral use

Ireland

| Tad Pharma GmbH, |
| --- |
| Heinz-Lohmann-Strasse 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH,

Heinz-Lohmann-Strasse 5

D-27472 Cuxhaven

Norflocux 400

400 mg

Tablet

Oral use

Italy

| Sede legale: ABC Farmaceutici S.p.A. |
| --- |
| Corso Vittorio Emanuele II, 72 |
| Torino |
| Italy |

Sede legale: ABC Farmaceutici S.p.A.

Corso Vittorio Emanuele II, 72

Torino

Italy

Norfloxacina

400 mg

Capsule

Oral use

Italy

| Actavis Italy SpA |
| --- |
| V. Jose'Escrivia De Balaguer, 6 |
| I-21047 Saronno (VA) |

Actavis Italy SpA

V. Jose'Escrivia De Balaguer, 6

I-21047 Saronno (VA)

Norfloxacina

400 mg

Film-coated tablet

Oral use

Italy

| Boniscontro & Gazzone s.r.l. |
| --- |
| Via Pavia, 6 |
| I-20136 Milano |

Boniscontro & Gazzone s.r.l.

Via Pavia, 6

I-20136 Milano

Renoxacin

400 mg

Film-coated tablet

Oral use

Italy

| EG S.p.A. |
| --- |
| Via Pavia, 6 |
| I-20131 Milano |

EG S.p.A.

Via Pavia, 6

I-20131 Milano

Norfloxacina EG

400 mg

Film-coated tablet

Oral use

Italy

| Farmaceutici Caber S.p.A. |
| --- |
| Viale Città d'Europa, 681 |
| I-00144 Roma |

Farmaceutici Caber S.p.A.

Viale Città d'Europa, 681

I-00144 Roma

Flossac

400 mg

Capsule

Oral use

Italy

| GlaxoSmithKline S.p.A. |
| --- |
| Via A. Fleming, 2 |
| I-37135 Verona |

GlaxoSmithKline S.p.A.

Via A. Fleming, 2

I-37135 Verona

Sebercim

400 mg

Tablet

Oral use

Italy

| Jet Generici s.r.l. |
| --- |
| Via Mario Lalli, 8 |
| I-56127 Pisa |

Jet Generici s.r.l.

Via Mario Lalli, 8

I-56127 Pisa

Norfloxacina

400 mg

Capsule

Oral use

Italy

| Sede legale: Laboratori Alter s.r.l. |
| --- |
| Via Egadi, 7 |
| I-20144 Milano |

Sede legale: Laboratori Alter s.r.l.

Via Egadi, 7

I-20144 Milano

Norfloxacina

400 mg

Film-coated tablet

Oral use

Italy

| Merck Sharp & Dohme S.p.A. |
| --- |
| Via G. Fabbroni, 6 |
| I-00191 Roma |

Merck Sharp & Dohme S.p.A.

Via G. Fabbroni, 6

I-00191 Roma

Noroxin

400 mg

Film-coated tablet

Oral use

Italy

| Neopharmed S.p.A |
| --- |
| Via G. Fabbroni, 6 |
| I-00191 Roma |

Neopharmed S.p.A

Via G. Fabbroni, 6

I-00191 Roma

Utinor

400 mg

Film-coated tablet

Oral use

Italy

| Pliva Pharma S.p.A. |
| --- |
| Via Tranquillo Cremona, 10 |
| I-20092 Cinisello Balsamo (MI) |

Pliva Pharma S.p.A.

Via Tranquillo Cremona, 10

I-20092 Cinisello Balsamo (MI)

Norfloxacina

400 mg

Film-coated tablet

Oral use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni, 1 |
| I-21040 Origgio (VA) |

Sandoz S.p.A.

Largo Umberto Boccioni, 1

I-21040 Origgio (VA)

Norfloxacina Sandoz

400 mg

Film-coated tablet

Oral use

Italy

| So. Se. Pharm S.r.l. |
| --- |
| Via dei Castelli Romani, 22 |
| I-00040 Pomezia (RM) |

So. Se. Pharm S.r.l.

Via dei Castelli Romani, 22

I-00040 Pomezia (RM)

Uticina

400 mg

Film-coated tablet

Oral use

Italy

| Tad Pharma Italia S.r.l. |
| --- |
| Via Felice Casati, 16 |
| I-20124 Milano |

Tad Pharma Italia S.r.l.

Via Felice Casati, 16

I-20124 Milano

Norfloxacina

400 mg

Film-coated tablet

Oral use

Italy

| Francia Farmaceutici Industria Farmaco Biologica Srl |
| --- |
| Via dei Pestagalli, 7 |
| Milano |

Francia Farmaceutici Industria Farmaco Biologica Srl

Via dei Pestagalli, 7

Milano

Diperflox

540 mg of Norfloxacin pivaloil-oxy- methyl-ester as 400 mg of Norfloxacin

Tablet

Oral use

Italy

| Francia Farmaceutici Industria Farmaco Biologica Srl |
| --- |
| Via dei Pestagalli, 7 |
| Milano |

Francia Farmaceutici Industria Farmaco Biologica Srl

Via dei Pestagalli, 7

Milano

Diperflox

100 ml contains 5,4 g of Norfloxacin pivaloil-oxy- methyl-ester as 4,0 g of Norfloxacin

Oral suspension

Oral use

Italy

| Pliva Pharma S.p.A |
| --- |
| Via Tranquillo Cremona, 10 |
| I-20092 Cinisello Balsamo (MI) |

Pliva Pharma S.p.A

Via Tranquillo Cremona, 10

I-20092 Cinisello Balsamo (MI)

Norflox

540 mg of Norfloxacin pivaloil-oxy- methyl-ester as 400 mg of Norfloxacin

Tablet

Oral use

Italy

| Pliva Pharma S.p.A. |
| --- |
| Via Tranquillo Cremona, 10 |
| I-20092 Cinisello Balsamo (MI) |

Pliva Pharma S.p.A.

Via Tranquillo Cremona, 10

I-20092 Cinisello Balsamo (MI)

Norflox

100 ml contains 5,4 g of Norfloxacin pivaloil-oxy- methyl-ester as 4,0 g of Norfloxacin

Oral suspension

Oral use

Latvia

| Cipla (UK) Ltd |
| --- |
| Old Post House |
| Hithrow Road |
| Webbger Bridge |
| Surrey KT 138TS |
| United Kingdom |

Cipla (UK) Ltd

Old Post House

Hithrow Road

Webbger Bridge

Surrey KT 138TS

United Kingdom

Norflox

400 mg

Film-coated tablet

Oral use

Latvia

| Krka d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

Krka d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

Nolicin

400 mg

Film-coated tablet

Oral use

Latvia

| Laboratorios Inkeysa S.A. |
| --- |
| Juran XXIII, 15-19, 3a planta |
| ES-08950, Esplugas de Llobregat |
| Barcelona |
| Spain |

Laboratorios Inkeysa S.A.

Juran XXIII, 15-19, 3a planta

ES-08950, Esplugas de Llobregat

Barcelona

Spain

Norflok

400 mg

Tablet

Oral use

Latvia

| Ranbaxy (UK) Ltd. |
| --- |
| 20 Balderton Street |
| London W1K6TL |
| United Kingdom |

Ranbaxy (UK) Ltd.

20 Balderton Street

London W1K6TL

United Kingdom

Norbactin

400 mg

Film-coated tablet

Oral use

Lithuania

| Krka d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

Krka d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

Nolicin

400 mg

Film-coated tablet

Oral use

Lithuania

| Ranbaxy (UK) Ltd. |
| --- |
| C.P. House |
| 97/107 Uxbridge Road |
| Ealing |
| London W5 5TL |
| United Kingdom |

Ranbaxy (UK) Ltd.

C.P. House

97/107 Uxbridge Road

Ealing

London W5 5TL

United Kingdom

Norbactin

400 mg

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Zoroxin

400 mg

Tablet

Oral use

Luxembourg

| Eurogenerics |
| --- |
| Esplanade Heysel, B.22 |
| B-1020 Bruxelles |

Eurogenerics

Esplanade Heysel, B.22

B-1020 Bruxelles

Norfloxacin — Eurogenerics

400 mg

Tablet

Oral use

Luxembourg

| TAD Pharm. Werk |
| --- |
| Heinz-Lohmann Str. 5 |
| D-27472 Cuxhaven |

TAD Pharm. Werk

Heinz-Lohmann Str. 5

D-27472 Cuxhaven

Norflosal

400 mg

Tablet

Oral use

Malta

| Merck Sharp & Dohme |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

United Kingdom

Utinor 400 mg tablets

400 mg

Tablet

Oral use

Malta

| Anfarm Hellas S.A. |
| --- |
| K Paleologou & Perikleous |
| GR-153 32 Halandri Athens |

Anfarm Hellas S.A.

K Paleologou & Perikleous

GR-153 32 Halandri Athens

Fluseminal 400 mg tablets

400 mg

Tablet

Oral use

The Netherlands

| Ratiopharm Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

Ratiopharm Nederland BV

Ronde Tocht 11

1507 CC Zaandam

Nederland

Norfloxacine ratiopharm 400 mg

400 mg

Tablet

Oral use

Netherlands

| Centrafarm Services B.V. |
| --- |
| Nieuwe Donk 9, |
| 4879 AC Etten-Leur |
| Nederland |

Centrafarm Services B.V.

Nieuwe Donk 9,

4879 AC Etten-Leur

Nederland

Norfloxacine CF 400 mg

400 mg

Film-coated tablet

Oral use

Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| Nederland |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

Nederland

Norfloxacine Sandoz tablet 400

400 mg

Film-coated tablet

Oral use

Netherlands

| Merck Generics BV |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| Nederland |

Merck Generics BV

Dieselweg 25

3752 LB Bunschoten

Nederland

Norfloxacine Merck 400 mg

400 mg

Film-coated tablet

Oral use

Poland

| Krka d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo Mesto |

Krka d.d.

Šmarješka cesta 6

SLO-8501 Novo Mesto

Nolicin

400 mg

Tablet

Oral use

Poland

| Pabianickie Zakłady Farmaceutyczne Polfa S.A. |
| --- |
| ul. Marszałka J. Piłsudskiego 5 |
| PL-95-200 Pabianice |

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

ul. Marszałka J. Piłsudskiego 5

PL-95-200 Pabianice

Norsept

400 mg

Film-coated tablet

Oral use

Portugal

| Labesfal — Laboratórios Almiro, S.A. |
| --- |
| P-3465-051 Campo de Besteiros |

Labesfal — Laboratórios Almiro, S.A.

P-3465-051 Campo de Besteiros

Besflox

400 mg

Coated tablet

Oral use

Portugal

| Cinfa Portugal, Lda. |
| --- |
| Av. Tomás Ribeiro, 43 — Bloco 2, 3o F — |
| Edifício Neopark |
| P-2790-221 Carnaxide |

Cinfa Portugal, Lda.

Av. Tomás Ribeiro, 43 — Bloco 2, 3o F —

Edifício Neopark

P-2790-221 Carnaxide

Norfloxacina Cinfa 400 mg comprimidos

400 mg

Coated tablet

Oral use

Portugal

| Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro — Edifício Tejo — 6o Piso, |
| P-2790-143 Carnaxide |

Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro — Edifício Tejo — 6o Piso,

P-2790-143 Carnaxide

Norfloxacina ratiopharm 400 mg comprimidos Revestidos

400 mg

Coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama 19 — Porto Salvo |
| P-2770-192 Paço d' Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama 19 — Porto Salvo

P-2770-192 Paço d' Arcos

Noroxin

400 mg

Film-coated tablet

Oral use

Portugal

| Bialfar — Produtos Farmacêuticos, S.A. |
| --- |
| Av. da Siderurgia Nacional |
| P.O. Box 56 |
| P-4745-457 S. Mamede do Coronado |

Bialfar — Produtos Farmacêuticos, S.A.

Av. da Siderurgia Nacional

P.O. Box 56

P-4745-457 S. Mamede do Coronado

Uroflox

400 mg

Coated tablet

Oral use

Romania

| S.C. AC Helcor S.R.L. |
| --- |
| Str. Victor Babeș nr 50 |
| Jud. Maramureș |
| RO-430092 Baia Mare |

S.C. AC Helcor S.R.L.

Str. Victor Babeș nr 50

Jud. Maramureș

RO-430092 Baia Mare

H-NORFLOXACIN 400 mg

400 mg

Film-coated tablets

Oral use

Romania

| S.C. Labormed-Pharma S.A. |
| --- |
| Splaiul Independenţei nr. 319E |
| Sector 6 |
| RO-060044 București |

S.C. Labormed-Pharma S.A.

Splaiul Independenţei nr. 319E

Sector 6

RO-060044 București

Norfloxacina LPH 400 mg

400 mg

Film-coated tablet

Oral use

Romania

| Krka d.d . |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

Krka d.d .

Šmarješka cesta 6

SLO-8501 Novo mesto

Nolicin 400 mg

400 mg

Film-coated tablet

Oral use

Romania

| Ozone Laboratories Ltd |
| --- |
| 38 Princes Court |
| 88 Brompton Road |
| Knightsbridge |
| SW3 1ES London |
| United Kingdom |

Ozone Laboratories Ltd

38 Princes Court

88 Brompton Road

Knightsbridge

SW3 1ES London

United Kingdom

Norfloxacin 400 mg

400 mg

Film-coated tablet

Oral use

Romania

| Ozone Laboratories Ltd |
| --- |
| 38 Princes Court |
| 88 Brompton Road |
| Knightsbridge |
| SW3 1ES London |
| United Kingdom |

Ozone Laboratories Ltd

38 Princes Court

88 Brompton Road

Knightsbridge

SW3 1ES London

United Kingdom

Norfloxacin Ozone 400 mg

400 mg

Film-coated tablet

Oral use

Romania

| S.C. Terapia S.A. |
| --- |
| Str. Fabricii nr. 124 |
| RO-400640 Cluj-Napoca |

S.C. Terapia S.A.

Str. Fabricii nr. 124

RO-400640 Cluj-Napoca

Norfloxacina Terapia 400 mg

400 mg

Film-coated tablet

Oral use

Romania

| S.C. Laropharm S.R.L. |
| --- |
| Șoseaua Alexandriei nr. 145 A |
| Jud. Ilfov |
| RO-077025 Comuna Bragadiru |

S.C. Laropharm S.R.L.

Șoseaua Alexandriei nr. 145 A

Jud. Ilfov

RO-077025 Comuna Bragadiru

Norfloxacin 400 mg

400 mg

Film-coated tablet

Oral use

Slovak Republic

| Krka d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

Krka d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

Nolicin

400 mg

Film-coated tablet

Oral use

Slovak Republic

| Medochemie Ltd. |
| --- |
| P.O.Box 51409 |
| CY-3505 Limassol |

Medochemie Ltd.

P.O.Box 51409

CY-3505 Limassol

Gyrablock 400 mg

400 mg

Film-coated tablet

Oral use

Slovenia

| Krka d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

Krka d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

Nolicin filmsko obložene tablete 400 mg

400 mg

Film-coated tablet

Oral use

Spain

| Sharp & Dohme, S.A |
| --- |
| Josefa Valcárcel, 38 |
| E-28027 Madrid |

Sharp & Dohme, S.A

Josefa Valcárcel, 38

E-28027 Madrid

Noroxin 400 mg comprimidos recubiertos con película

400 mg

Film-coated tablet

Oral use

Spain

| VP Pharma Baru, S.L. |
| --- |
| C/ Valle de Tobalina, 16 Nave 3 |
| E-28021 Madrid |

VP Pharma Baru, S.L.

C/ Valle de Tobalina, 16 Nave 3

E-28021 Madrid

Xasmun 400 mg comprimidos

400 mg

Film-coated tablet

Oral use

Spain

| Abbott Laboratories, S.A |
| --- |
| Avda. de Burgos, 91 |
| E-28050 Madrid |

Abbott Laboratories, S.A

Avda. de Burgos, 91

E-28050 Madrid

Baccidal

400 mg

Capsule

Oral use

Spain

| Sandoz Farmaceutica, S.A |
| --- |
| Avenida de Osa Mayor 4 |
| E-28023 Aravaca Madrid |

Sandoz Farmaceutica, S.A

Avenida de Osa Mayor 4

E-28023 Aravaca Madrid

Nalion comprimidos

400 mg

Film-coated tablet

Oral use

Spain

| Inkeysa, S.A |
| --- |
| Juan XXIII, 15 - 19, 3a planta |
| E-08950 Esplugas de Llobregat |

Inkeysa, S.A

Juan XXIII, 15 - 19, 3a planta

E-08950 Esplugas de Llobregat

Norflok comprimidos

400 mg

Film-coated tablet

Oral use

Spain

| Biosarto, S.A |
| --- |
| Foc, 68-82 |
| E-08038 Barcelona |

Biosarto, S.A

Foc, 68-82

E-08038 Barcelona

Senro cápsulas

400 mg

Capsule

Oral use

Spain

| Almirall Prodesfarma S.A |
| --- |
| Ronda General Mitre, 151 |
| E-08022 Barcelona |

Almirall Prodesfarma S.A

Ronda General Mitre, 151

E-08022 Barcelona

Uroctal comprimidos

400 mg

Film-coated tablet

Oral use

Spain

| Alacan S.A |
| --- |
| Capricornio, 5 |
| E-03006 Alicante |

Alacan S.A

Capricornio, 5

E-03006 Alicante

Esclebin 400 mg comprimidos recubiertos con película

400 mg

Film-coated tablet

Oral use

Spain

| Quimifar, S.A |
| --- |
| Comadran, 37 |
| E-08210 Barbera del Valles |

Quimifar, S.A

Comadran, 37

E-08210 Barbera del Valles

Amicrobin capsulas

400 mg

Capsule

Oral use

Spain

| Qualigen |
| --- |
| Avda, Barcelona, 69 |
| E-08970 Sant Joan Despi Barcelona |

Qualigen

Avda, Barcelona, 69

E-08970 Sant Joan Despi Barcelona

Norfloxacino Qualigen 400 mg comprimidos recubiertos con película

400 mg

Film-coated tablet

Oral use

Sweden

| Astra Zeneca AB |
| --- |
| S-151 85 Södertälje |

Astra Zeneca AB

S-151 85 Södertälje

Lexinor

200 mg

400 mg

Film-coated tablet

Oral use

Sweden

| Stada Arzneimittel |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

Stada Arzneimittel

Stadastraße 2-18

D-61118 Bad Vilbel

Norfloxacin Stada

400 mg

Film-coated tablet

Oral use

Sweden

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Norfloxacin Sandoz

400 mg

Film-coated tablet

Oral use

Sweden

| Recip AB |
| --- |
| Box 906 |
| S-170 09 Solna |

Recip AB

Box 906

S-170 09 Solna

Norfloxacin Astra Zeneca

200 mg

400 mg

Film-coated tablet

Oral use

Sweden

| Alternova AB |
| --- |
| Vallgatan 11 |
| S-170 67 Solna |

Alternova AB

Vallgatan 11

S-170 67 Solna

Norfloxacin Alternova

200 mg

400 mg

Film-coated tablet

Oral use

Sweden

| Krka Sverige AB |
| --- |
| Göta Ark 175 |
| Medborgarplatsen 25 |
| S-118 72 Stockholm |

Krka Sverige AB

Göta Ark 175

Medborgarplatsen 25

S-118 72 Stockholm

Norfloxacin Krka

200 mg

400 mg

Film-coated tablet

Oral use

United Kingdom

| Merck Sharpe & Dohme Limted |
| --- |
| Hertford Road, Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharpe & Dohme Limted

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Utinor Tablets 400 mg

400 mg

Coated tablet

Oral use

United Kingdom

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5 |
| D-27472Cuxhaven |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

D-27472Cuxhaven

Norfloxacin 400 mg Tablets

400 mg

Coated tablet

Oral use

United Kingdom

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5 |
| D-27472 Cuxhaven |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

D-27472 Cuxhaven

Norflocux

400 mg

Coated tablet

Oral use

United Kingdom

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Norfloxacin-Ratiopharm 400

400 mg

Coated tablet

Oral use

United Kingdom

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Norquin 400

400 mg

Coated tablet

Oral use

United Kingdom

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Norflocin 400

400 mg

Coated tablet

Oral use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Wyeth-Lederle Pharma GmbH |
| Storchengasse 1 |
| A-1150 Vienna |

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin 50 mg — Tabletten

50 mg

Tablets

Oral use

Cyprus

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor

37,5 mg

Tablets

Oral use

Cyprus

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor

50 mg

Tablets

Oral use

Cyprus

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor

75 mg

Tablets

Oral use

Denmark

| John Wyeth & Brother Ltd. |
| --- |
| New Lane |
| Havant |
| Hants PO9 2NG |
| United Kingdom |

John Wyeth & Brother Ltd.

New Lane

Havant

Hants PO9 2NG

United Kingdom

Efexor

37,5 mg

Tablets

Oral use

Finland

| John Wyeth & Brother Ltd. |
| --- |
| New Lane |
| Havant |
| Hants PO9 2NG |
| United Kingdom |

John Wyeth & Brother Ltd.

New Lane

Havant

Hants PO9 2NG

United Kingdom

Efexor

37,5 mg

Tablets

Oral use

Finland

| John Wyeth & Brother Ltd. |
| --- |
| New Lane |
| Havant |
| Hants PO9 2NG |
| United Kingdom |

John Wyeth & Brother Ltd.

New Lane

Havant

Hants PO9 2NG

United Kingdom

Efexor

75 mg

Tablets

Oral use

France

| Wyeth Pharmaceuticals France |
| --- |
| Coeur Défense — Tour A — la Défense 4 |
| F-92931 Paris la Défense Cedex |

Wyeth Pharmaceuticals France

Coeur Défense — Tour A — la Défense 4

F-92931 Paris la Défense Cedex

Effexor

25 mg

Tablets

Oral use

France

| Wyeth Pharmaceuticals France |
| --- |
| Coeur Défense — Tour A — la Défense 4 |
| F-92931 Paris la Défense Cedex |

Wyeth Pharmaceuticals France

Coeur Défense — Tour A — la Défense 4

F-92931 Paris la Défense Cedex

Effexor

50 mg

Tablets

Oral use

France

| Wyeth Pharmaceuticals France |
| --- |
| Coeur Défense — Tour A — la Défense 4 |
| F-92931 Paris la Défense Cedex |

Wyeth Pharmaceuticals France

Coeur Défense — Tour A — la Défense 4

F-92931 Paris la Défense Cedex

Trevilor

50 mg

Tablets

Oral use

Germany

| Wyeth Pharma GmbH |
| --- |
| Wienburgstraße 207 |
| D-48159 Muenster |

Wyeth Pharma GmbH

Wienburgstraße 207

D-48159 Muenster

Trevilor Tabletten 25 mg

25 mg

Tablets

Oral use

Germany

| Wyeth Pharma GmbH |
| --- |
| Wienburgstraße 207 |
| D-48159 Muenster |

Wyeth Pharma GmbH

Wienburgstraße 207

D-48159 Muenster

Trevilor Tabletten 37,5 mg

37,5 mg

Tablets

Oral use

Germany

| Wyeth Pharma GmbH |
| --- |
| Wienburgstraße 207 |
| D-48159 Muenster |

Wyeth Pharma GmbH

Wienburgstraße 207

D-48159 Muenster

Trevilor Tabletten 50 mg

50 mg

Tablets

Oral use

Germany

| Wyeth Pharma GmbH |
| --- |
| Wienburgstraße 207 |
| D-48159 Muenster |

Wyeth Pharma GmbH

Wienburgstraße 207

D-48159 Muenster

Trevilor Tabletten 75 mg

75 mg

Tablets

Oral use

Greece

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor

25 mg

Tablets

Oral use

Greece

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor

37,5 mg

Tablets

Oral use

Greece

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor

50 mg

Tablets

Oral use

Greece

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor

75 mg

Tablets

Oral use

Iceland

| John Wyeth & Brothers Ltd |
| --- |
| New Lane, |
| Havant |
| Hants P09 2NG |
| United Kingdom |

John Wyeth & Brothers Ltd

New Lane,

Havant

Hants P09 2NG

United Kingdom

Efexor

37,5 mg

Tablets

Oral use

Ireland

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

37,5 mg

Tablets

Oral use

Ireland

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

75 mg

Tablets

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Efexor

25 mg

Tablets

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Efexor

37,5 mg

Tablets

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Efexor

50 mg

Tablets

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Efexor

75 mg

Tablets

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Faxine

37,5 mg

Tablets

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Faxine

50 mg

Tablets

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Faxine

75 mg

Tablets

Oral use

Malta

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

37,5 mg

Tablets

Oral use

Malta

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

75 mg

Tablets

Oral use

Norway

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

37,5 mg

Tablets

Oral use

Spain

| WYETH FARMA S.A. |
| --- |
| Ctra. De Burgos Km 23 Desvio Algete |
| E-28700 San Sebastián de los Reyes |

WYETH FARMA S.A.

Ctra. De Burgos Km 23 Desvio Algete

E-28700 San Sebastián de los Reyes

VANDRAL 37,5 mg comprimidos

37,5 mg

Tablets

Oral use

Spain

| WYETH FARMA S.A. |
| --- |
| Ctra. De Burgos Km 23 Desvio Algete |
| E-28700 San Sebastián de los Reyes |

WYETH FARMA S.A.

Ctra. De Burgos Km 23 Desvio Algete

E-28700 San Sebastián de los Reyes

VANDRAL 50 mg comprimidos

50 mg

Tablets

Oral use

Spain

| WYETH FARMA S.A. |
| --- |
| Ctra. De Burgos Km 23 Desvio Algete |
| E-28700 San Sebastián de los Reyes |

WYETH FARMA S.A.

Ctra. De Burgos Km 23 Desvio Algete

E-28700 San Sebastián de los Reyes

VANDRAL 75 mg comprimidos

75 mg

Tablets

Oral use

Spain

| Laboratorios Almirall, S.A. |
| --- |
| General Mitre, 151 |
| E-08022 Barcelona |

Laboratorios Almirall, S.A.

General Mitre, 151

E-08022 Barcelona

Dobupal 37,5 mg comprimidos

37,5 mg

Tablets

Oral use

Spain

| Laboratorios Almirall, S.A. |
| --- |
| General Mitre, 151 |
| E-08022 Barcelona |

Laboratorios Almirall, S.A.

General Mitre, 151

E-08022 Barcelona

Dobupal 50 mg comprimidos

50 mg

Tablets

Oral use

Spain

| Laboratorios Almirall, S.A. |
| --- |
| General Mitre, 151 |
| E-08022 Barcelona |

Laboratorios Almirall, S.A.

General Mitre, 151

E-08022 Barcelona

Dobupal 75 mg comprimidos

75 mg

Tablets

Oral use

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

25 mg

Tablets

Oral use

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

37,5 mg

Tablets

Oral use

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

50 mg

Tablets

Oral use

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor

75 mg

Tablets

Oral use

---

ANNEX VI

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

| Member State | Marketing Authorisation Holder | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Wyeth-Lederle Pharma GmbH |
| Storchengasse 1 |
| A-1150 Vienna |

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 37,5 mg — Kapseln

37,5 mg

Modified-release capsule, hard

Oral use

Austria

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 75 mg — Kapseln

75 mg

Modified-release capsule, hard

Oral use

Austria

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 150 mg — Kapseln

150 mg

Modified-release capsule, hard

Oral use

Belgium

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

EFEXOR -EXEL 150

150 mg

Prolonged-release capsules

Oral use

Belgium

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

EFEXOR-EXEL 37,5

37,5 mg

Prolonged-release capsules

Oral use

Belgium

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

EFEXOR-EXEL 75

75 mg

Prolonged-release capsules

Oral use

Belgium

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

Venlax 150 mg

150 mg

Prolonged-release capsules

Oral use

Belgium

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

Venlax 37,5 mg

37,5 mg

Prolonged-release capsules

Oral use

Belgium

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

Venlax 75 mg

75 mg

Prolonged-release capsules

Oral use

Bulgaria

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 75 mg

75 mg

Prolonged-release capsule, hard

Oral use

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 150 mg

150 mg

Prolonged-release capsule, hard

Oral use

Cyprus

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor XR

75 mg

Prolonged-release capsules

Oral use

Cyprus

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor XR

150 mg

Prolonged-release capsules

Oral use

Czech Republic

| Wyeth-Lederle Pharma GmbH., |
| --- |
| Storchengasse 1 |
| 1150 Vienna |
| Austria |

Wyeth-Lederle Pharma GmbH.,

Storchengasse 1

1150 Vienna

Austria

EFECTIN ER 37,5 mg

37,5 mg

Prolonged-release capsules

Oral use

Czech Republic

| Wyeth-Lederle Pharma GmbH. |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH.

Storchengasse 1

A-1150 Vienna

EFECTIN ER 75 mg

75 mg

Prolonged-release capsules

Oral use

Czech Republic

| Wyeth-Lederle Pharma GmbH. |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH.

Storchengasse 1

A-1150 Vienna

EFECTIN ER 150 mg

150 mg

Prolonged-release capsules

Oral use

Denmark

| Wyeth AB |
| --- |
| Dalvägen 12 |
| P.O. Box 1822 |
| S-17 124 Solna |

Wyeth AB

Dalvägen 12

P.O. Box 1822

S-17 124 Solna

Efexor Depot

37,5 mg

Prolonged-release capsule, hard

Oral use

Denmark

| Wyeth AB |
| --- |
| Dalvägen 12 |
| P.O. Box 1822 |
| S-17 124 Solna |

Wyeth AB

Dalvägen 12

P.O. Box 1822

S-17 124 Solna

Efexor Depot

75 mg

Prolonged-release capsule, hard

Oral use

Denmark

| Wyeth AB |
| --- |
| Dalvägen 12 |
| P.O. Box 1822 |
| S-17 124 Solna |

Wyeth AB

Dalvägen 12

P.O. Box 1822

S-17 124 Solna

Efexor Depot

150 mg

Prolonged-release capsule, hard

Oral use

Estonia

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFEXOR XR

75 mg

Prolonged-release capsules, hard

Oral use

Estonia

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFEXOR XR

37,5 mg

Prolonged-release capsules, hard

Oral use

Estonia

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFEXOR XR

150 mg

Prolonged-release capsules, hard

Oral use

Finland

| Wyeth AB |
| --- |
| Dalvägen 12 |
| B.O. Box 1822 |
| S-171 24 Solna |

Wyeth AB

Dalvägen 12

B.O. Box 1822

S-171 24 Solna

Efexor Depot

37,5 mg

Prolonged-release capsule, hard

Oral use

Finland

| Wyeth AB |
| --- |
| Dalvägen 12 |
| B.O. Box 1822 |
| S-171 24 Solna |

Wyeth AB

Dalvägen 12

B.O. Box 1822

S-171 24 Solna

Efexor Depot

75 mg

Prolonged-release capsule, hard

Oral use

Finland

| Wyeth AB |
| --- |
| Dalvägen 12 |
| B.O. Box 1822 |
| S-171 24 Solna |

Wyeth AB

Dalvägen 12

B.O. Box 1822

S-171 24 Solna

Efexor Depot

150 mg

Prolonged-release capsule, hard

Oral use

France

| Wyeth Pharmaceuticals France |
| --- |
| Coeur Défense — Tour A — la Défense 4 |
| F-92931 Paris la Défense Cedex |

Wyeth Pharmaceuticals France

Coeur Défense — Tour A — la Défense 4

F-92931 Paris la Défense Cedex

Effexor L.P.

37,5 mg

Prolonged-release capsules

Oral use

France

| Wyeth Pharmaceuticals France |
| --- |
| Coeur Défense — Tour A — la Défense 4 |
| F-92931 Paris la Défense Cedex |

Wyeth Pharmaceuticals France

Coeur Défense — Tour A — la Défense 4

F-92931 Paris la Défense Cedex

Effexor L.P.

75 mg

Prolonged-release capsules

Oral use

France

| Wyeth Pharmaceuticals France |
| --- |
| Coeur Défense — Tour A — la Défense 4 |
| F-92931 Paris la Défense Cedex |

Wyeth Pharmaceuticals France

Coeur Défense — Tour A — la Défense 4

F-92931 Paris la Défense Cedex

Venlafaxine Wyeth LP

37,5 mg

Prolonged-release capsules

Oral use

France

| Wyeth Pharmaceuticals France |
| --- |
| Coeur Défense — Tour A — la Défense 4 |
| F-92931 Paris la Défense Cedex |

Wyeth Pharmaceuticals France

Coeur Défense — Tour A — la Défense 4

F-92931 Paris la Défense Cedex

Venlafaxine Wyeth LP

75 mg

Prolonged-release capsules

Oral use

Germany

| Wyeth Pharma GmbH |
| --- |
| Wienburgstraße 207 |
| D-48159 Muenster |

Wyeth Pharma GmbH

Wienburgstraße 207

D-48159 Muenster

Trevilor retard 37,5 mg

37,5 mg

Prolonged-release capsule, hard

Oral use

Germany

| Wyeth Pharma GmbH |
| --- |
| Wienburgstraße 207 |
| D-48159 Muenster |

Wyeth Pharma GmbH

Wienburgstraße 207

D-48159 Muenster

Trevilor retard 75 mg

75 mg

Prolonged-release capsule, hard

Oral use

Germany

| Wyeth Pharma GmbH |
| --- |
| Wienburgstraße 207 |
| D-48159 Muenster |

Wyeth Pharma GmbH

Wienburgstraße 207

D-48159 Muenster

Trevilor retard 150 mg

150 mg

Prolonged-release capsule, hard

Oral use

Greece

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor XR

75 mg

Prolonged-release capsule

Oral use

Greece

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor XR

150 mg

Prolonged-release capsule

Oral use

Greece

| Wyeth Hellas S.A. |
| --- |
| 126, Kyprou & 25th Martiou str. |
| GR-164 52 Argyroupolis-Athens |

Wyeth Hellas S.A.

126, Kyprou & 25th Martiou str.

GR-164 52 Argyroupolis-Athens

Efexor XR

37,5 mg

Prolonged-release capsule

Oral use

Iceland

| Wyeth AB |
| --- |
| P.O. Box 1822 |
| S-171 24 Solna |

Wyeth AB

P.O. Box 1822

S-171 24 Solna

Efexor Depot

37,5 mg

Prolonged-release capsule, hard

Oral use

Iceland

| Wyeth AB |
| --- |
| P.O. Box 1822 |
| S-171 24 Solna |

Wyeth AB

P.O. Box 1822

S-171 24 Solna

Efexor Depot

75 mg

Prolonged-release capsule, hard

Oral use

Iceland

| Wyeth AB |
| --- |
| P.O. Box 1822 |
| S-171 24 Solna |

Wyeth AB

P.O. Box 1822

S-171 24 Solna

Efexor Depot

150 mg

Prolonged-release capsule, hard

Oral use

Ireland

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor XL

75 mg

Prolonged-release capsules

Oral use

Ireland

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor XL

150 mg

Prolonged-release capsules

Oral use

Ireland

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor XL

37,5 mg

Prolonged-release capsules

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Efexor

75 mg

Prolonged-release hard capsules

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Efexor

150 mg

Prolonged-release hard capsules

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Faxine

75 mg

Prolonged-release hard capsules

Oral use

Italy

| Wyeth Medica Ireland |
| --- |
| Little Connell — Newbridge |
| Co. Kildare |
| Ireland |

Wyeth Medica Ireland

Little Connell — Newbridge

Co. Kildare

Ireland

Faxine

150 mg

Prolonged-release hard capsules

Oral use

Latvia

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efexor XR

37,5 mg

Prolonged-release hard capsules

Oral use

Latvia

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efexor XR 75

75 mg

Prolonged-release capsules, hard

Oral use

Latvia

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efexor XR 150

150 mg

Prolonged-release capsules, hard

Oral use

Lithuania

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efexor XR

37,5 mg

Prolonged-release capsules, hard

Oral use

Lithuania

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efexor XR

75 mg

Prolonged-release capsules, hard

Oral use

Lithuania

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efexor XR

150 mg

Prolonged-release capsules, hard

Oral use

Luxembourg

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

EFEXOR -EXEL 150

150 mg

Prolonged-release capsules

Oral use

Luxembourg

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

EFEXOR-EXEL 37,5

37,5 mg

Prolonged-release capsules

Oral use

Luxembourg

| Wyeth Pharmaceuticals SA/NV |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve |

Wyeth Pharmaceuticals SA/NV

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

EFEXOR-EXEL 75

75 mg

Prolonged-release capsules

Oral use

Malta

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor XL

75 mg

Prolonged-release capsules

Oral use

Malta

| John Wyeth & Brother Ltd |
| --- |
| trading as Wyeth Laboratories |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Ltd

trading as Wyeth Laboratories

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor XL

150 mg

Prolonged-release capsules

Oral use

Netherlands

| Wyeth Pharmaceuticals B.V. |
| --- |
| P.O. Box 255 |
| 2130 AG Hoofddorp |
| Nederland |

Wyeth Pharmaceuticals B.V.

P.O. Box 255

2130 AG Hoofddorp

Nederland

Efexor XR 37,5

37,5 mg

Prolonged-release capsules

Oral use

Netherlands

| Wyeth Pharmaceuticals B.V. |
| --- |
| P.O. Box 255 |
| 2130 AG Hoofddorp |
| Nederland |

Wyeth Pharmaceuticals B.V.

P.O. Box 255

2130 AG Hoofddorp

Nederland

Efexor XR 75

75 mg

Prolonged-release capsules

Oral use

Netherlands

| Wyeth Pharmaceuticals B.V. |
| --- |
| P.O. Box 255 |
| 2130 AG Hoofddorp |
| Nederland |

Wyeth Pharmaceuticals B.V.

P.O. Box 255

2130 AG Hoofddorp

Nederland

Efexor XR 150

150 mg

Prolonged-release capsules

Oral use

Norway

| Wyeth AB |
| --- |
| P.O. Box 1822, |
| S-171 24 Solna |

Wyeth AB

P.O. Box 1822,

S-171 24 Solna

Efexor Depot

37,5 mg

Prolonged-release capsule, hard

Oral use

Norway

| Wyeth AB |
| --- |
| P.O. Box 1822, |
| S-171 24 Solna |

Wyeth AB

P.O. Box 1822,

S-171 24 Solna

Efexor Depot

75 mg

Prolonged-release capsule, hard

Oral use

Norway

| Wyeth AB |
| --- |
| P.O. Box 1822, |
| S-171 24 Solna |

Wyeth AB

P.O. Box 1822,

S-171 24 Solna

Efexor Depot

150 mg

Prolonged-release capsule, hard

Oral use

Poland

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |
| Austria |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Austria

Efectin ER 37,5

37,5 mg

Prolonged-release capsules

Oral use

Poland

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 75

75 mg

Prolonged-release capsules

Oral use

Poland

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 150

150 mg

Prolonged-release capsules

Oral use

Portugal

| Wyeth Lederle |
| --- |
| Portugal (Farma), Lda. |
| Rua Dr. António Loureiro Borges, 2 |
| Arquiparque — Miraflores |
| P-1495-131 Algés |

Wyeth Lederle

Portugal (Farma), Lda.

Rua Dr. António Loureiro Borges, 2

Arquiparque — Miraflores

P-1495-131 Algés

Efexor XR

37,5 mg

Prolonged-release capsules

Oral use

Portugal

| Wyeth Lederle |
| --- |
| Portugal (Farma), Lda. |
| Rua Dr. António Loureiro Borges, 2 |
| Arquiparque — Miraflores |
| P-1495-131 Algés |

Wyeth Lederle

Portugal (Farma), Lda.

Rua Dr. António Loureiro Borges, 2

Arquiparque — Miraflores

P-1495-131 Algés

Efexor XR

75 mg

Prolonged-release capsules

Oral use

Portugal

| Wyeth Lederle |
| --- |
| Portugal (Farma), Lda. |
| Rua Dr. António Loureiro Borges, 2 |
| Arquiparque — Miraflores |
| P-1495-131 Algés |

Wyeth Lederle

Portugal (Farma), Lda.

Rua Dr. António Loureiro Borges, 2

Arquiparque — Miraflores

P-1495-131 Algés

Efexor XR

150 mg

Prolonged-release capsules

Oral use

Romania

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 37,5 mg

37,5 mg

Prolonged-release capsules

Oral use

Romania

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 75 mg

75 mg

Prolonged-release capsules

Oral use

Romania

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 150 mg

150 mg

Prolonged-release capsules

Oral use

Slovak Republic

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 37,5mg cps plg

37,5mg

Prolonged-release capsules

Oral use

Slovak Republic

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 75 mg cps plg

75 mg

Prolonged-release capsules

Oral use

Slovak Republic

| Wyeth-Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth-Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

Efectin ER 150 mg cps plg

150 mg

Prolonged-release capsules

Oral use

Slovenia

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem

150 mg

Prolonged-release capsule, hard

Oral use

Slovenia

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 75 mg trde kapsule s podaljšanim sproščanjem

75 mg

Prolonged-release capsule, hard

Oral use

Slovenia

| Wyeth Lederle Pharma GmbH |
| --- |
| Storchengasse 1 |
| A-1150 Vienna |

Wyeth Lederle Pharma GmbH

Storchengasse 1

A-1150 Vienna

EFECTIN ER 37,5 mg trde kapsule s podaljšanim sproščanjem

37,5 mg

Prolonged-release capsule, hard

Oral use

Spain

| WYETH FARMA S.A. |
| --- |
| Ctra. De Burgos Km 23 Desvio Algete |
| E-28700 San Sebastián de los Reyes |

WYETH FARMA S.A.

Ctra. De Burgos Km 23 Desvio Algete

E-28700 San Sebastián de los Reyes

VANDRAL RETARD 75 mg cápsulas de liberación prologada

75 mg

Prolonged-release capsules

Oral use

Spain

| WYETH FARMA S.A. |
| --- |
| Ctra. De Burgos Km 23 Desvio Algete |
| E-28700 San Sebastián de los Reyes |

WYETH FARMA S.A.

Ctra. De Burgos Km 23 Desvio Algete

E-28700 San Sebastián de los Reyes

VANDRAL RETARD 150 mg cápsulas de liberación prologada

150 mg

Prolonged-release capsules

Oral use

Spain

| Laboratorios Almirall, S.A. |
| --- |
| General Mitre, 151 |
| E-08022 Barcelona |

Laboratorios Almirall, S.A.

General Mitre, 151

E-08022 Barcelona

Dobupal Retard 75 mg cápsulas de liberación prologada

75 mg

Prolonged-release capsules

Oral use

Spain

| Laboratorios Almirall, S.A. |
| --- |
| General Mitre, 151 |
| E-08022 Barcelona |

Laboratorios Almirall, S.A.

General Mitre, 151

E-08022 Barcelona

Dobupal Retard 150 mg cápsulas de liberación prolongada

150 mg

Prolonged-release capsules

Oral use

Sweden

| Wyeth AB |
| --- |
| P.O. Box 1822 |
| S-171 42 Solna |

Wyeth AB

P.O. Box 1822

S-171 42 Solna

Efexor Depot

37,5 mg

Prolonged-release capsule, hard

Oral use

Sweden

| Wyeth AB |
| --- |
| P.O. Box 1822 |
| S-171 42 Solna |

Wyeth AB

P.O. Box 1822

S-171 42 Solna

Efexor Depot

75 mg

Prolonged-release capsule, hard

Oral use

Sweden

| Wyeth AB |
| --- |
| P.O. Box 1822 |
| S-171 42 Solna |

Wyeth AB

P.O. Box 1822

S-171 42 Solna

Efexor Depot

150 mg

Prolonged-release capsule, hard

Oral use

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor XL

75 mg

Modified release capsule

Oral use

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Efexor XL

150 mg

Modified release capsule

Oral use

---