# C_2006236EN.01000701.xml

| 30.9.2006 | EN | Official Journal of the European Union | C 236/7 |
| --- | --- | --- | --- |

30.9.2006

EN

Official Journal of the European Union

C 236/7

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1

2

(2006/C 236/03)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 4.8.2006 | Neurontin | See Annex I | See Annex I | 8.8.2006 |
| 10.8.2006 | Thelin | Encysive (UK) Limited |
| Alder Castle House |
| 10 Noble Street |
| London EC2V 7QJ |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

4.8.2006

Neurontin

See Annex I

See Annex I

8.8.2006

10.8.2006

Thelin

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London EC2V 7QJ

United Kingdom

The Decision is sent to all member States.

11.8.2006

21.8.2006

Prozac

See Annex II

See Annex II

23.8.2006

21.8.2006

Cobactan IV 4;5%

See Annex III

See Annex III

23.8.2006

21.8.2006

Ceftriaxone Tyrol Pharma

See Annex IV

See Annex IV

23.8.2006

28.8.2006

Exjade

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

The Decision is sent to all member States.

30.8.2006

—   Suspension 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 |
| --- | --- | --- | --- | --- |
| 28.8.2006 | Cetirizine Copyfarm | See Annex V | See Annex V | 30.8.2006 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

28.8.2006

Cetirizine Copyfarm

See Annex V

See Annex V

30.8.2006

---

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

1

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

2

---

ANNEX I

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

| Member State | Marketing Authorisation Holder | Applicant | Invented Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Gesellschaft m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1

A-1210 Wien

Neurontin

300 mg

Capsules, hard

Oral use

Austria

| Pfizer Corporation Austria Gesellschaft m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1

A-1210 Wien

Neurontin

400 mg

Capsules, hard

Oral use

Austria

| Pfizer Corporation Austria Gesellschaft m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1

A-1210 Wien

Neurontin

600 mg

Film-coated tablets

Oral use

Austria

| Pfizer Corporation Austria Gesellschaft m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1

A-1210 Wien

Neurontin

800 mg

Film-coated tablets

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

Neurontin

100 mg

Capsules, hard

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

Neurontin

300 mg

Capsules, hard

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

Neurontin

400 mg

Capsules, hard

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

Neurontin

600 mg

Film-coated tablets

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

Neurontin

800 mg

Film-coated tablets

Oral use

Czech Republic

| Pfizer spol S R.O. |
| --- |
| Stroupežnického17 |
| CZ-15000 Praha 5 |

Pfizer spol S R.O.

Stroupežnického17

CZ-15000 Praha 5

Neurontin

100 mg

Capsules, hard

Oral use

Czech Republic

| Pfizer spol S R.O. |
| --- |
| Stroupežnického17 |
| CZ-15000 Praha 5 |

Pfizer spol S R.O.

Stroupežnického17

CZ-15000 Praha 5

Neurontin

300 mg

Capsules, hard

Oral use

Czech Republic

| Pfizer spol S R.O. |
| --- |
| Stroupežnického17 |
| CZ-15000 Praha 5 |

Pfizer spol S R.O.

Stroupežnického17

CZ-15000 Praha 5

Neurontin

400 mg

Capsules, hard

Oral use

Czech Republic

| Pfizer spol S R.O. |
| --- |
| Stroupežnického17 |
| CZ-15000 Praha 5 |

Pfizer spol S R.O.

Stroupežnického17

CZ-15000 Praha 5

Neurontin

600 mg

Film-coated tablets

Oral use

Czech Republic

| Pfizer spol S R.O. |
| --- |
| Stroupežnického17 |
| CZ-15000 Praha 5 |

Pfizer spol S R.O.

Stroupežnického17

CZ-15000 Praha 5

Neurontin

800 mg

Film-coated tablets

Oral use

Cyprus

| Pfizer Hellas A.E. |
| --- |
| 243, Messoghion |
| Ave., Neo Psychiko |
| GR-154 51 |

Pfizer Hellas A.E.

243, Messoghion

Ave., Neo Psychiko

GR-154 51

Neurontin

300 mg

Capsules, hard

Oral use

Cyprus

| Pfizer Hellas A.E. |
| --- |
| 243, Messoghion |
| Ave., Neo Psychiko |
| GR-154 51 |

Pfizer Hellas A.E.

243, Messoghion

Ave., Neo Psychiko

GR-154 51

Neurontin

400 mg

Capsules, hard

Oral use

Denmark

| Pfizer Aps. |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps.

Lautrupvang 8

DK-2750 Ballerup

Gabapentin ‘Pfizer’

300 mg

Capsules, hard

Oral use

Denmark

| Pfizer Aps. |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps.

Lautrupvang 8

DK-2750 Ballerup

Gabapentin ‘Pfizer’

400 mg

Capsules, hard

Oral use

Denmark

| Pfizer Aps. |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps.

Lautrupvang 8

DK-2750 Ballerup

Gabapentin ‘Pfizer’

600 mg

Film-coated tablets

Oral use

Denmark

| Pfizer Aps. |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps.

Lautrupvang 8

DK-2750 Ballerup

Gabapentin ‘Pfizer’

800 mg

Film-coated tablets

Oral use

Estonia

| Pfizer Europe MA EEIG Ramsgate Road |
| --- |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

Neurontin

100 mg

Capsules, hard

Oral use

Estonia

| Pfizer Europe MA EEIG Ramsgate Road |
| --- |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

Neurontin

300 mg

Capsules, hard

Oral use

Estonia

| Pfizer Europe MA EEIG Ramsgate Road |
| --- |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

Neurontin

400 mg

Capsules, hard

Oral use

Estonia

| Pfizer Europe MA EEIG Ramsgate Road |
| --- |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

Neurontin

600 mg

Film-coated tablets

Oral use

Estonia

| Pfizer Europe MA EEIG Ramsgate Road |
| --- |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

Neurontin

800 mg

Film-coated tablets

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| FIN-00330 Helsinki |

Pfizer Oy

Tietokuja 4

FIN-00330 Helsinki

Neurontin

300 mg

Capsules, hard

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| FIN-00330 Helsinki |

Pfizer Oy

Tietokuja 4

FIN-00330 Helsinki

Neurontin

400 mg

Capsules, hard

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| FIN-00330 Helsinki |

Pfizer Oy

Tietokuja 4

FIN-00330 Helsinki

Neurontin

600 mg

Film-coated tablets

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| FIN-00330 Helsinki |

Pfizer Oy

Tietokuja 4

FIN-00330 Helsinki

Neurontin

800 mg

Film-coated tablets

Oral use

France

| Pfizer |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25, avenue du Docteur Lannelongue

F-75668 Paris Cedex 14

Neurontin

100 mg

Capsules, hard

Oral use

France

| Pfizer |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25, avenue du Docteur Lannelongue

F-75668 Paris Cedex 14

Neurontin

300 mg

Capsules, hard

Oral use

France

| Pfizer |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25, avenue du Docteur Lannelongue

F-75668 Paris Cedex 14

Neurontin

400 mg

Capsules, hard

Oral use

France

| Pfizer |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25, avenue du Docteur Lannelongue

F-75668 Paris Cedex 14

Neurontin

600 mg

Film-coated tablets

Oral use

France

| Pfizer |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25, avenue du Docteur Lannelongue

F-75668 Paris Cedex 14

Neurontin

800 mg

Film-coated tablets

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D-76139 Karlsruhe

Neurontin

100 mg

Capsules, hard

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D-76139 Karlsruhe

Neurontin

300 mg

Capsules, hard

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D-76139 Karlsruhe

Neurontin

400 mg

Capsules, hard

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D-76139 Karlsruhe

Neurontin

600 mg

Film-coated tablets

Oral use

Germany

| Parke-Davis GmbH |
| --- |
| Pfizerstrasse 1 |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstrasse 1

D-76139 Karlsruhe

Neurontin

800 mg

Film-coated tablets

Oral use

Greece

| Pfizer Hellas |
| --- |
| 243 Messoghion Ave. |
| Neo Psychiko |
| GR-154 51 |

Pfizer Hellas

243 Messoghion Ave.

Neo Psychiko

GR-154 51

Neurontin

100 mg

Capsules, hard

Oral use

Greece

| Pfizer Hellas |
| --- |
| 243 Messoghion Ave. |
| Neo Psychiko |
| GR-154 51 |

Pfizer Hellas

243 Messoghion Ave.

Neo Psychiko

GR-154 51

Neurontin

300 mg

Capsules, hard

Oral use

Greece

| Pfizer Hellas |
| --- |
| 243 Messoghion Ave. |
| Neo Psychiko |
| GR-154 51 |

Pfizer Hellas

243 Messoghion Ave.

Neo Psychiko

GR-154 51

Neurontin

400 mg

Capsules, hard

Oral use

Greece

| Pfizer Hellas |
| --- |
| 243 Messoghion Ave. |
| Neo Psychiko |
| GR-154 51 |

Pfizer Hellas

243 Messoghion Ave.

Neo Psychiko

GR-154 51

Neurontin

600 mg

Film-coated tablets

Oral use

Greece

| Pfizer Hellas |
| --- |
| 243 Messoghion Ave. |
| Neo Psychiko |
| GR-154 51 |

Pfizer Hellas

243 Messoghion Ave.

Neo Psychiko

GR-154 51

Neurontin

800 mg

Film-coated tablets

Oral use

Iceland

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

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Neurontin

100 mg

Capsules, hard

Oral use

Iceland

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

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Neurontin

300 mg

Capsules, hard

Oral use

Iceland

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

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Neurontin

400 mg

Capsules, hard

Oral use

Iceland

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

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Neurontin

600 mg

Film-coated tablets

Oral use

Iceland

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

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Neurontin

800 mg

Film-coated tablets

Oral use

Ireland

| Pfizer Healthcare Ireland 9 Riverwalk |
| --- |
| National Digital Pk |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland 9 Riverwalk

National Digital Pk

Citywest Business Campus

Dublin 24

Ireland

| c/o Pfizer Ltd |
| --- |
| Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

c/o Pfizer Ltd

Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

100 mg

Capsules, hard

Oral use

Ireland

| Pfizer Healthcare Ireland 9 Riverwalk |
| --- |
| National Digital Pk |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland 9 Riverwalk

National Digital Pk

Citywest Business Campus

Dublin 24

Ireland

| c/o Pfizer Ltd |
| --- |
| Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

c/o Pfizer Ltd

Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

300 mg

Capsules, hard

Oral use

Ireland

| Pfizer Healthcare Ireland 9 Riverwalk |
| --- |
| National Digital Pk |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland 9 Riverwalk

National Digital Pk

Citywest Business Campus

Dublin 24

Ireland

| c/o Pfizer Ltd |
| --- |
| Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

c/o Pfizer Ltd

Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

400 mg

Capsules, hard

Oral use

Ireland

| Pfizer Healthcare Ireland 9 Riverwalk |
| --- |
| National Digital Pk |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland 9 Riverwalk

National Digital Pk

Citywest Business Campus

Dublin 24

Ireland

| c/o Pfizer Ltd |
| --- |
| Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

c/o Pfizer Ltd

Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

600 mg

Film-coated tablets

Oral use

Ireland

| Pfizer Healthcare Ireland 9 Riverwalk |
| --- |
| National Digital Pk |
| Citywest Business Campus |
| Dublin 24 |
| Irlande |

Pfizer Healthcare Ireland 9 Riverwalk

National Digital Pk

Citywest Business Campus

Dublin 24

Irlande

| c/o Pfizer Ltd |
| --- |
| Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

c/o Pfizer Ltd

Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

800 mg

Film-coated tablets

Oral use

Hungary

| Pfizer Kft. |
| --- |
| H-1123 Budapest |
| Alkotás u. 53. MOM Park ‘F’ épület |

Pfizer Kft.

H-1123 Budapest

Alkotás u. 53. MOM Park ‘F’ épület

Neurontin

100 mg

Capsules, hard

Oral use

Hungary

| Pfizer Kft. |
| --- |
| H-1123 Budapest |
| Alkotás u. 53. MOM Park ‘F’ épület |

Pfizer Kft.

H-1123 Budapest

Alkotás u. 53. MOM Park ‘F’ épület

Neurontin

300 mg

Capsules, hard

Oral use

Hungary

| Pfizer Kft. |
| --- |
| H-1123 Budapest |
| Alkotás u. 53. MOM Park ‘F’ épület |

Pfizer Kft.

H-1123 Budapest

Alkotás u. 53. MOM Park ‘F’ épület

Neurontin

400 mg

Capsules, hard

Oral use

Hungary

| Pfizer Kft. |
| --- |
| H-1123 Budapest |
| Alkotás u. 53. MOM Park ‘F’ épület |

Pfizer Kft.

H-1123 Budapest

Alkotás u. 53. MOM Park ‘F’ épület

Neurontin

600 mg

Film-coated tablets

Oral use

Hungary

| Pfizer Kft. |
| --- |
| H-1123 Budapest |
| Alkotás u. 53. MOM Park ‘F’ épület |

Pfizer Kft.

H-1123 Budapest

Alkotás u. 53. MOM Park ‘F’ épület

Neurontin

800 mg

Film-coated tablets

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione, 113 |
| I-00188 Roma |

Pfizer Italia S.r.l.

Via Valbondione, 113

I-00188 Roma

Neurontin

100 mg

Capsules, hard

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione, 113 |
| I-00188 Roma |

Pfizer Italia S.r.l.

Via Valbondione, 113

I-00188 Roma

Neurontin

300 mg

Capsules, hard

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione, 113 |
| I-00188 Roma |

Pfizer Italia S.r.l.

Via Valbondione, 113

I-00188 Roma

Neurontin

400 mg

Capsules, hard

Oral use

Latvia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

100 mg

Capsules, hard

Oral use

Latvia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

300 mg

Capsules, hard

Oral use

Latvia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

400 mg

Capsules, hard

Oral use

Latvia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

600 mg

Film-coated tablets

Oral use

Latvia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

800 mg

Film-coated tablets

Oral use

Lithuania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

100 mg

Capsules, hard

Oral use

Lithuania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

300 mg

Capsules, hard

Oral use

Lithuania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

400 mg

Capsules, hard

Oral use

Lithuania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

600 mg

Film-coated tablets

Oral use

Lithuania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Neurontin

800 mg

Film-coated tablets

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

Neurontin

100 mg

Capsules, hard

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

Neurontin

300 mg

Capsules, hard

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

Neurontin

400 mg

Capsules, hard

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

Neurontin

600 mg

Film-coated tablets

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

Neurontin

800 mg

Film-coated tablets

Oral use

Malta

| Pfizer Hellas A.E. |
| --- |
| Alketou 5 |
| GR-11633 Athens |

Pfizer Hellas A.E.

Alketou 5

GR-11633 Athens

Neurontin

100 mg

Capsules, hard

Oral use

Malta

| Pfizer Hellas A.E. |
| --- |
| Alketou 5 |
| GR-11633 Athens |

Pfizer Hellas A.E.

Alketou 5

GR-11633 Athens

Neurontin

300 mg

Capsules, hard

Oral use

Malta

| Pfizer Hellas A.E. |
| --- |
| Alketou 5 |
| GR-11633 Athens |

Pfizer Hellas A.E.

Alketou 5

GR-11633 Athens

Neurontin

400 mg

Capsules, hard

Oral use

Malta

| Pfizer Hellas A.E. |
| --- |
| Alketou 5 |
| GR-11633 Athens |

Pfizer Hellas A.E.

Alketou 5

GR-11633 Athens

Neurontin

600 mg

Film-coated tablets

Oral use

Norway

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

Pfizer AS

Postboks 3

N-1324 Lysaker

Neurontin

100 mg

Capsules, hard

Oral use

Norway

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

Pfizer AS

Postboks 3

N-1324 Lysaker

Neurontin

300 mg

Capsules, hard

Oral use

Norway

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

Pfizer AS

Postboks 3

N-1324 Lysaker

Neurontin

400 mg

Capsules, hard

Oral use

Norway

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

Pfizer AS

Postboks 3

N-1324 Lysaker

Neurontin

600 mg

Film-coated tablets

Oral use

Norway

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

Pfizer AS

Postboks 3

N-1324 Lysaker

Neurontin

800 mg

Film-coated tablets

Oral use

Poland

| Parke-Davis GmbH |
| --- |
| Pfizerstr 1, |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstr 1,

D-76139 Karlsruhe

Neurontin

100 mg

Capsules, hard

Oral use

Poland

| Parke-Davis GmbH |
| --- |
| Pfizerstr 1, |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstr 1,

D-76139 Karlsruhe

Neurontin

300 mg

Capsules, hard

Oral use

Poland

| Parke-Davis GmbH |
| --- |
| Pfizerstr 1, |
| D-76139 Karlsruhe |

Parke-Davis GmbH

Pfizerstr 1,

D-76139 Karlsruhe

Neurontin

400 mg

Capsules, hard

Oral use

Poland

| Pfizer Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 28 |
| PL-02-697 Warszawa |

Pfizer Polska Sp. z o.o.

ul. Rzymowskiego 28

PL-02-697 Warszawa

Neurontin

600 mg

Film-coated tablets

Oral use

Poland

| Pfizer Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 28 |
| PL-02-697 Warszawa |

Pfizer Polska Sp. z o.o.

ul. Rzymowskiego 28

PL-02-697 Warszawa

Neurontin

800 mg

Film-coated tablets

Oral use

Portugal

| Laboratórios Pfizer |
| --- |
| Lda. Lagoas Park |
| Edifício no 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer

Lda. Lagoas Park

Edifício no 10

P-2740-271 Porto Salvo

Neurontin

100 mg

Capsules, hard

Oral use

Portugal

| Laboratórios Pfizer |
| --- |
| Lda. Lagoas Park |
| Edifício no 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer

Lda. Lagoas Park

Edifício no 10

P-2740-271 Porto Salvo

Neurontin

300 mg

Capsules, hard

Oral use

Portugal

| Laboratórios Pfizer |
| --- |
| Lda. Lagoas Park |
| Edifício no 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer

Lda. Lagoas Park

Edifício no 10

P-2740-271 Porto Salvo

Neurontin

400 mg

Capsules, hard

Oral use

Portugal

| Laboratórios Pfizer |
| --- |
| Lda. Lagoas Park |
| Edifício no 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer

Lda. Lagoas Park

Edifício no 10

P-2740-271 Porto Salvo

Neurontin

600 mg

Film-coated tablets

Oral use

Portugal

| Laboratórios Pfizer |
| --- |
| Lda. Lagoas Park |
| Edifício no 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer

Lda. Lagoas Park

Edifício no 10

P-2740-271 Porto Salvo

Neurontin

800 mg

Film-coated tablets

Oral use

The Netherlands

| Pfizer BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| Nederland |

Pfizer BV

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Nederland

Neurontin

100 mg

Capsules, hard

Oral use

The Netherlands

| Pfizer BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| Nederland |

Pfizer BV

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Nederland

Neurontin

300 mg

Capsules, hard

Oral use

The Netherlands

| Pfizer BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| Nederland |

Pfizer BV

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Nederland

Neurontin

400 mg

Capsules, hard

Oral use

The Netherlands

| Pfizer BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| Nederland |

Pfizer BV

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Nederland

Neurontin

600 mg

Film-coated tablets

Oral use

The Netherlands

| Pfizer BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| Nederland |

Pfizer BV

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Nederland

Neurontin

800 mg

Film-coated tablets

Oral use

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 283, route d'Arlon |
| L-8011 Strassen |

Pfizer Luxembourg SARL

283, route d'Arlon

L-8011 Strassen

Neurontin

100 mg

Capsules, hard

Oral use

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 283, route d'Arlon |
| L-8011 Strassen |

Pfizer Luxembourg SARL

283, route d'Arlon

L-8011 Strassen

Neurontin

300 mg

Capsules, hard

Oral use

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 283, route d'Arlon |
| L-8011 Strassen |

Pfizer Luxembourg SARL

283, route d'Arlon

L-8011 Strassen

Neurontin

400 mg

Capsules, hard

Oral use

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 283, route d'Arlon |
| L-8011 Strassen |

Pfizer Luxembourg SARL

283, route d'Arlon

L-8011 Strassen

Neurontin

600 mg

Film-coated tablets

Oral use

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 283, route d'Arlon |
| L-8011 Strassen |

Pfizer Luxembourg SARL

283, route d'Arlon

L-8011 Strassen

Neurontin

800 mg

Film-coated tablets

Oral use

The Slovak Republic

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Contact address:

| Pfizer Luxembourg SARL |
| --- |
| Branch office |
| Dubravska cesta 2, |
| SK-841 04 Bratislava |

Pfizer Luxembourg SARL

Branch office

Dubravska cesta 2,

SK-841 04 Bratislava

Neurontin

100 mg

Capsules, hard

Oral use

The Slovak Republic

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Contact address:

| Pfizer Luxembourg SARL |
| --- |
| Branch office |
| Dubravska cesta 2, |
| SK-841 04 Bratislava |

Pfizer Luxembourg SARL

Branch office

Dubravska cesta 2,

SK-841 04 Bratislava

Neurontin

300 mg

Capsules, hard

Oral use

The Slovak Republic

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Contact address:

| Pfizer Luxembourg SARL |
| --- |
| Branch office |
| Dubravska cesta 2, |
| SK-841 04 Bratislava |

Pfizer Luxembourg SARL

Branch office

Dubravska cesta 2,

SK-841 04 Bratislava

Neurontin

400 mg

Capsules, hard

Oral use

The Slovak Republic

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Contact address:

| Pfizer Luxembourg SARL |
| --- |
| Branch office |
| Dubravska cesta 2, |
| SK-841 04 Bratislava |

Pfizer Luxembourg SARL

Branch office

Dubravska cesta 2,

SK-841 04 Bratislava

Neurontin

600 mg

Film-coated tablets

Oral use

The Slovak Republic

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Contact address:

| Pfizer Luxembourg SARL |
| --- |
| Branch office |
| Dubravska cesta 2, |
| SK-841 04 Bratislava |

Pfizer Luxembourg SARL

Branch office

Dubravska cesta 2,

SK-841 04 Bratislava

Neurontin

800 mg

Film-coated tablets

Oral use

Spain

| Parke-Davis, S.L. |
| --- |
| Avda. de Europa |
| 20 B. Parque |
| Empresarial La Moraleja |
| E-28108 Alcobendas |

Parke-Davis, S.L.

Avda. de Europa

20 B. Parque

Empresarial La Moraleja

E-28108 Alcobendas

Neurontin

300 mg

Capsules, hard

Oral use

Spain

| Parke-Davis, S.L. |
| --- |
| Avda. de Europa |
| 20 B. Parque |
| Empresarial La Moraleja |
| E-28108 Alcobendas |

Parke-Davis, S.L.

Avda. de Europa

20 B. Parque

Empresarial La Moraleja

E-28108 Alcobendas

Neurontin

400 mg

Capsules, hard

Oral use

Spain

| Parke-Davis, S.L. |
| --- |
| Avda. de Europa |
| 20 B. Parque |
| Empresarial La Moraleja |
| E-28108 Alcobendas |

Parke-Davis, S.L.

Avda. de Europa

20 B. Parque

Empresarial La Moraleja

E-28108 Alcobendas

Neurontin

600 mg

Film-coated tablets

Oral use

Spain

| Parke-Davis, S.L. |
| --- |
| Avda. de Europa |
| 20 B. Parque |
| Empresarial La Moraleja |
| E-28108 Alcobendas |

Parke-Davis, S.L.

Avda. de Europa

20 B. Parque

Empresarial La Moraleja

E-28108 Alcobendas

Neurontin

800 mg

Film-coated tablets

Oral use

Sweden

| Pfizer AB |
| --- |
| S-191 90 Sollentuna |

Pfizer AB

S-191 90 Sollentuna

Neurontin

100 mg

Capsules, hard

Oral use

Sweden

| Pfizer AB |
| --- |
| S-191 90 Sollentuna |

Pfizer AB

S-191 90 Sollentuna

Neurontin

300 mg

Capsules, hard

Oral use

Sweden

| Pfizer AB |
| --- |
| S-191 90 Sollentuna |

Pfizer AB

S-191 90 Sollentuna

Neurontin

400 mg

Capsules, hard

Oral use

Sweden

| Pfizer AB |
| --- |
| S-191 90 Sollentuna |

Pfizer AB

S-191 90 Sollentuna

Neurontin

600 mg

Film-coated tablets

Oral use

Sweden

| Pfizer AB |
| --- |
| S-191 90 Sollentuna |

Pfizer AB

S-191 90 Sollentuna

Neurontin

800 mg

Film-coated tablets

Oral use

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |
| c/o Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

c/o Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

100 mg

Capsules, hard

Oral use

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |
| c/o Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

c/o Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

300 mg

Capsules, hard

Oral use

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |
| c/o Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

c/o Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

400 mg

Capsules, hard

Oral use

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |
| c/o Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

c/o Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

600 mg

Film-coated tablets

Oral use

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |
| c/o Walton Oaks |
| Dorking Road |
| Tadworth |
| Surrey KT20 7NS |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

c/o Walton Oaks

Dorking Road

Tadworth

Surrey KT20 7NS

Neurontin

800 mg

Film-coated tablets

Oral use

---

ANNEX II

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 | Eli Lilly Ges.m.b.H. |
| Kölblgasse 8-10 |
| A-1030 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Eli Lilly Ges.m.b.H.

Kölblgasse 8-10

A-1030 Wien

Fluctine

20 mg/5 ml

Oral solution

Oral use

Austria

| Eli Lilly Ges.m.b.H. |
| --- |
| Kölblgasse 8-10 |
| A-1030 Wien |

Eli Lilly Ges.m.b.H.

Kölblgasse 8-10

A-1030 Wien

Fluctine

20 mg

Capsule, hard

Oral use

Belgium

| Eli Lilly Benelux S.A. |
| --- |
| rue de l'Étuve 52 Stoofstraat |
| B-1000 Brussel |

Eli Lilly Benelux S.A.

rue de l'Étuve 52 Stoofstraat

B-1000 Brussel

Prozac

20 mg

Capsule, hard

Oral use

Belgium

| Eli Lilly Benelux S.A. |
| --- |
| rue de l'Étuve 52 Stoofstraat |
| B-1000 Brussel |

Eli Lilly Benelux S.A.

rue de l'Étuve 52 Stoofstraat

B-1000 Brussel

Prozac

20 mg/5 ml

Oral solution

Oral use

Belgium

| Eli Lilly Benelux S.A. |
| --- |
| rue de l'Étuve 52 Stoofstraat |
| B-1000 Brussel |

Eli Lilly Benelux S.A.

rue de l'Étuve 52 Stoofstraat

B-1000 Brussel

Fontex

20 mg

Capsule, hard

Oral use

Belgium

| Eli Lilly Benelux S.A. |
| --- |
| rue de l'Étuve 52 Stoofstraat |
| B-1000 Brussel |

Eli Lilly Benelux S.A.

rue de l'Étuve 52 Stoofstraat

B-1000 Brussel

Fluoxetine ‘Lilly’

20 mg

Capsule, hard

Oral use

France

| Lilly France S.A.S. |
| --- |
| 13, rue Pagès |
| F-92158 Suresnes Cedex |

Lilly France S.A.S.

13, rue Pagès

F-92158 Suresnes Cedex

Prozac

20 mg

Capsule, hard

Oral use

France

| Lilly France S.A.S. |
| --- |
| 13, rue Pagès |
| F-92158 Suresnes Cedex |

Lilly France S.A.S.

13, rue Pagès

F-92158 Suresnes Cedex

Prozac

20 mg/5 ml

Oral solution

Oral use

France

| Lilly France S.A.S. |
| --- |
| 13, rue Pagès |
| F-92158 Suresnes Cedex |

Lilly France S.A.S.

13, rue Pagès

F-92158 Suresnes Cedex

Fluoxétine Lilly

20 mg

Capsule, hard

Oral use

France

| LICO SARL |
| --- |
| 203, Bureaux de la Colline |
| F-92213 Saint Cloud |

LICO SARL

203, Bureaux de la Colline

F-92213 Saint Cloud

Fluoxétine RPG

20 mg

Capsule, hard

Oral use

Germany

| Lilly Deutschland GmbH |
| --- |
| Saalburgstr. 153 |
| D-61350 Bad Homburg |
| Germany |

Lilly Deutschland GmbH

Saalburgstr. 153

D-61350 Bad Homburg

Germany

Fluctin

20 mg

Capsule, hard

Oral use

Germany

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

Lilly Deutschland GmbH

Saalburgstr. 153

D-61350 Bad Homburg

Fluctin

20 mg/5 ml

Oral solution

Oral use

Greece

| Pharmaserve-Lilly S.A.C.I |
| --- |
| 15th KLM National Road |
| Athens-Lamia |
| GR-145 64 Kifissia |

Pharmaserve-Lilly S.A.C.I

15th KLM National Road

Athens-Lamia

GR-145 64 Kifissia

Ladose

20 mg/5 ml

Oral Solution

Oral use

Greece

| Pharmaserve-Lilly S.A.C.I |
| --- |
| 15th KLM National Road |
| Athens-Lamia |
| GR-145 64 Kifissia |

Pharmaserve-Lilly S.A.C.I

15th KLM National Road

Athens-Lamia

GR-145 64 Kifissia

Ladose

20 mg

Capsule, hard

Oral use

Ireland

| Eli Lilly & Co Ltd |
| --- |
| Kingsclere road |
| Basingstoke |
| Hampshire RG21 6XA |
| United Kingdom |

Eli Lilly & Co Ltd

Kingsclere road

Basingstoke

Hampshire RG21 6XA

United Kingdom

Prozac

20 mg/5 mg

Oral solution

Oral use

Ireland

| Eli Lilly & Co Ltd |
| --- |
| Kingsclere road |
| Basingstoke |
| Hampshire RG21 6XA |
| United Kingdom |

Eli Lilly & Co Ltd

Kingsclere road

Basingstoke

Hampshire RG21 6XA

United Kingdom

Prozac

20 mg

Capsule, hard

Oral use

Italy

| Eli Lilly Italia S.p.A. |
| --- |
| Via Gramsci 731/733 |
| I-50019 Sesto Fiorentino (Fi) |

Eli Lilly Italia S.p.A.

Via Gramsci 731/733

I-50019 Sesto Fiorentino (Fi)

Prozac

20 mg/5 ml

Oral Solution

Oral use

Italy

| Eli Lilly Italia S.p.A. |
| --- |
| Via Gramsci 731/733 |
| I-50019 Sesto Fiorentino (Fi) |

Eli Lilly Italia S.p.A.

Via Gramsci 731/733

I-50019 Sesto Fiorentino (Fi)

Prozac

20 mg

Capsule, hard

Oral use

Luxembourg

| Eli Lilly Benelux S.A |
| --- |
| Rue de l'Étuve 52 Stoofstraat |
| B-1000 Brussel |

Eli Lilly Benelux S.A

Rue de l'Étuve 52 Stoofstraat

B-1000 Brussel

Prozac

20 mg

Capsule, hard

Oral use

Luxembourg

| Eli Lilly Benelux S.A |
| --- |
| Rue de l'Étuve 52 Stoofstraat |
| B-1000 Brussel |

Eli Lilly Benelux S.A

Rue de l'Étuve 52 Stoofstraat

B-1000 Brussel

Fontex

20 mg

Capsule, hard

Oral use

Luxembourg

| Eli Lilly Benelux S.A |
| --- |
| Rue de l'Étuve 52 Stoofstraat |
| B-1000 Brussel |

Eli Lilly Benelux S.A

Rue de l'Étuve 52 Stoofstraat

B-1000 Brussel

Prozac

20 mg/5 ml

Oral Solution

Oral use

Portugal

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

Lilly Portugal

Produtos Farmacêuticos, Lda.

Rua Dr. António Loureiro Borges 1

Piso 1

Arquiparque

Miraflores 1499-016

Algés — Portugal

Prozac

20 mg

Capsule, hard

Oral use

Portugal

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

Lilly Portugal

Produtos Farmacêuticos, Lda.

Rua Dr. António Loureiro Borges 1

Piso 1

Arquiparque

Miraflores 1499-016

Algés — Portugal

Prozac

20 mg/5 ml

Oral Solution

Oral use

Spain

| Dista S.A. |
| --- |
| Avenida Industria 30 |
| E-28108 Alcobendas — Madrid |

Dista S.A.

Avenida Industria 30

E-28108 Alcobendas — Madrid

Prozac

20 mg/5 ml

Oral solution

Oral use

Spain

| Dista S.A. |
| --- |
| Avenida Industria 30 |
| E-28108 Alcobendas — Madrid |

Dista S.A.

Avenida Industria 30

E-28108 Alcobendas — Madrid

Prozac

20 mg

Capsule, hard

Oral use

Sweden

| Eli Lilly Sweden AB |
| --- |
| Gustav III:s boulevard 42 |
| P.O. Box 721 |
| S-16927 Solna |

Eli Lilly Sweden AB

Gustav III:s boulevard 42

P.O. Box 721

S-16927 Solna

Fontex

20 mg/5 ml

Oral Solution

Oral use

The Netherlands

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

Prozac

20 mg/5 ml

Oral solution

Oral use

The Netherlands

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

Prozac

20 mg

Capsule, hard

Oral use

UK

| Eli Lilly and Co Ltd |
| --- |
| Kingsclere road |
| Basingstoke |
| Hampshire RG21 6XA |
| United Kingdom |

Eli Lilly and Co Ltd

Kingsclere road

Basingstoke

Hampshire RG21 6XA

United Kingdom

Prozac

20 mg/5 ml

Oral Solution

Oral use

UK

| Eli Lilly and Co Ltd |
| --- |
| Kingsclere road |
| Basingstoke |
| Hampshire RG21 6XA |
| United Kingdom |

Eli Lilly and Co Ltd

Kingsclere road

Basingstoke

Hampshire RG21 6XA

United Kingdom

Prozac

20 mg

Capsule, hard

Oral use

---

ANNEX III

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER

| Member State | Marketing Authorisation Holder | Applicant | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Intervet Gesmbh Siemensstrasse 107 |
| A-1210 Wien |

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Austria

Intervet Gesmbh Siemensstrasse 107

A-1210 Wien

Cobactan

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Belgium

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Denmark

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan Vet.

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleissheim |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleissheim

Cobactan IV 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Greece

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan IV IM 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Spain

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

France

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan IV IM 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Hungary

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan IV 4.5 % A.U.V.

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Ireland

| Intervet Ireland |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Cephaguard IV IM 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Italy

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan 4.5 % IV IM

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Luxembourg

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Netherlands

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Poland

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cobactan 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

Portugal

| Intervet Portugal Lda. |
| --- |
| Estrada Nacional 249 |
| PT-2725-397 Mem Martins |

Intervet Portugal Lda.

Estrada Nacional 249

PT-2725-397 Mem Martins

Cobactan 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

United Kingdom

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Cephaguard IV IM 4.5 %

Powder and solvent for solution for injection

45 mg/ml

Horse (adult and foal)

Once or twice daily;

Intravenous and intramuscular use

1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

---

ANNEX IV

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

| Member State | Marketing Authorisation Holder | Applicant | Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Germany | Sandoz GmbH |
| Biochemiestrasse 10 |
| A-6250 Kundl |

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Germany

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

—

Ceftriaxon Tyrol Pharma 1 g Pulver zur Herstellung einer Injektions- oder Infusionslösung

1 g

Powder for solution for injection or infusion

Intramuscular and intravenous use

Germany

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

—

Ceftriaxon Tyrol Pharma 2 g Pulver zur Herstellung einer Infusionslösung

2 g

Powder for solution for infusion

Intravenous use

Finland

—

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

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Lendacin 1 g injektio-/infuusiokuiva-aine

liuosta varten

1 g

Powder for solution for injection or infusion

Intramuscular and intravenous use

Finland

—

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

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Lendacin 2 g infuusiokuiva-aine

liuosta varten

2 g

Powder for solution for infusion

Intravenous use

United Kingdom

—

| Sandoz Limited |
| --- |
| Woolmer way |
| Bordon |
| Hants GU35 9QE |
| United Kingdom |

Sandoz Limited

Woolmer way

Bordon

Hants GU35 9QE

United Kingdom

Ceftriaxone 1 g powder for solution for injection/infusion

1 g

Powder for solution for injection or infusion

Intramuscular and intravenous use

United Kingdom

—

| Sandoz Limited |
| --- |
| Woolmer way |
| Bordon |
| Hants GU35 9QE |
| United Kingdom |

Sandoz Limited

Woolmer way

Bordon

Hants GU35 9QE

United Kingdom

Ceftriaxone 2 g powder for solution for infusion

2 g

Powder for solution for infusion

Intravenous use

---

ANNEX V

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

CETIRIZINE DIHYDROCHLORIDE COPYFARM 10 mg AND ASSOCIATED NAMES

| Member State | Marketing Authorisation Holder | Product Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Denmark | Copyfarm A/S |
| Energivej 15, |
| POB 69 |
| DK-5260 Odense S |

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Denmark

Copyfarm A/S

Energivej 15,

POB 69

DK-5260 Odense S

Cetirizin ‘Copyfarm’

10 mg

Filmcoated tablet

Oral

Netherlands

| Copyfarm A/S |
| --- |
| Energivej 15 |
| POB 69 |
| DK-5260 Odense S |

Copyfarm A/S

Energivej 15

POB 69

DK-5260 Odense S

Cetirizine dihydrochloride Copyfarm 10 mg

10 mg

Filmcoated tablet

Oral

Norway

| Copyfarm A/S |
| --- |
| Energivej 15 |
| POB 69 |
| DK-5260 Odense S |

Copyfarm A/S

Energivej 15

POB 69

DK-5260 Odense S

Cetirizin Copyfarm

10 mg

filmcoated tablet

Oral

Sweden

| Copyfarm A/S |
| --- |
| Energivej 15 |
| POB 69 |
| DK-5260 Odense S |

Copyfarm A/S

Energivej 15

POB 69

DK-5260 Odense S

Cetirizin Copyfarm

10 mg

Filmcoated tablet

Oral

---