# C_2004215EN.01001101.xml

| 27.8.2004 | EN | Official Journal of the European Union | C 215/11 |
| --- | --- | --- | --- |

27.8.2004

EN

Official Journal of the European Union

C 215/11

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004

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

1

2

(2004/C 215/06)

| — | 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 |
| --- | --- | --- | --- | --- | --- |
| 29.7.2004 | Lopid (art 30) | See Annex I | See Annex I | 30.7.2004 |
| 11.8.2004 | Eprinomectin (Art 34) | See Annex II | See Annex II | 12.8.2004 |

—

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

29.7.2004

Lopid (art 30)

See Annex I

See Annex I

30.7.2004

11.8.2004

Eprinomectin (Art 34)

See Annex II

See Annex II

12.8.2004

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(1)  OJ L 311, 28.11.01, p. 67.

1

(2)  OJ L 311, 28.11.01, p. 1.

2

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ANNEX I

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H |
| Seidengasse 33–35 |
| A – 1070 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Pfizer Corporation Austria Ges.m.b.H

Seidengasse 33–35

A – 1070 Wien

Gevillon

450 mg

Film coated tablets

Oral use

Austria

| Pfizer Corporation Austria Ges.m.b.H |
| --- |
| Seidengasse 33–35 |
| A – 1070 Wien |

Pfizer Corporation Austria Ges.m.b.H

Seidengasse 33–35

A – 1070 Wien

Gevillon

900 mg

Film coated tablets

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

300 mg

Capsules

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

600 mg

Film-coated tablets

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

900 mg

Film-coated tablets

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

300 mg

Capsules

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

450 mg

Film-coated tablets

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

600 mg

Film-coated tablets

Oral use

Finland

| Pfizer Oy |
| --- |
| P.O. Box 45 |
| FIN–02601 Espoo |

Pfizer Oy

P.O. Box 45

FIN–02601 Espoo

Lopid

300 mg

Capsules

Oral use

Finland

| Pfizer Oy |
| --- |
| P.O. Box 45 |
| FIN–02601 Espoo |

Pfizer Oy

P.O. Box 45

FIN–02601 Espoo

Lopid

600 mg

Film-coated tablets

Oral use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Dr. Lannelongue |
| F–75014 Paris |

Pfizer

23-25 Avenue Du Dr. Lannelongue

F–75014 Paris

Lipur

450 mg

Film-coated tablets

Oral use

Germany

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

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Gevilon

450 mg

Film-coated tablets

Oral use

Germany

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

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Gevilon

600 mg

Film-coated tablets

Oral use

Germany

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

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Gevilon uno

900 mg

Film-coated tablets

Oral use

Germany

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

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Continulipid

450 mg

Film-coated tablets

Oral use

Germany

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

Parke-Davis GmbH

Pfizerstrasse 1

D–76139 Karlsruhe

Continulipid

600 mg

Film-coated tablets

Oral use

Greece

| Pfizer Hellas A.E. |
| --- |
| Alketou Street 5 |
| Athens |

Pfizer Hellas A.E.

Alketou Street 5

Athens

Lopid

600 mg

Film-coated tablets

Oral use

Greece

| Pfizer Hellas A.E. |
| --- |
| Alketou Street 5 |
| Athens |

Pfizer Hellas A.E.

Alketou Street 5

Athens

Lopid

900 mg

Film-coated tablets

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

300 mg

Capsules

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

450 mg

Film-coated tablets

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK–2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK–2750 Ballerup

Lopid

600 mg

Film-coated tablets

Oral use

Ireland

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh |
| Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh

Hampshire SO53 3ZQ

United Kingdom

Lopid

300 mg

Capsules

Oral use

Ireland

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh |
| Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh

Hampshire SO53 3ZQ

United Kingdom

Lopid

600 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

Lopid

600 mg

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

Lopid

900 mg

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

Lopid TC

900 mg

Granules

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

Lopid TC

1200 mg

Granules

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

300 mg

Capsules

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

600 mg

Film-coated tablets

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| Rue Léon Theodor 102 |
| B–1090 Bruxelles |

Pfizer S.A.

Rue Léon Theodor 102

B–1090 Bruxelles

Lopid

900 mg

Film-coated tablets

Oral use

Netherlands

| Pfizer BV |
| --- |
| Postbus 37 |
| NL–2900 AA Capelle a/d Ijssel |

Pfizer BV

Postbus 37

NL–2900 AA Capelle a/d Ijssel

Lopid

600 mg

Coated tablets

Oral use

Netherlands

| Pfizer BV |
| --- |
| Postbus 37 |
| NL–2900 AA Capelle a/d Ijssel |

Pfizer BV

Postbus 37

NL–2900 AA Capelle a/d Ijssel

Lopid

900 mg

Coated tablets

Oral use

Portugal

| Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 |
| --- |
| 2740-244 Porto Salvo |

Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10

2740-244 Porto Salvo

Lopid

300 mg

Capsules

Oral use

Portugal

| Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 |
| --- |
| 2740-244 Porto Salvo |

Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10

2740-244 Porto Salvo

Lopid

600 mg

Coated tablets

Oral use

Portugal

| Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 |
| --- |
| 2740-244 Porto Salvo |

Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10

2740-244 Porto Salvo

Lopid

900 mg

Coated tablets

Oral use

Spain

| Parke-Davis, S.L. (Pfizer Group) |
| --- |
| Av. de Europa 20-B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |

Parke-Davis, S.L. (Pfizer Group)

Av. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Lopid

600 mg

Tablets

Oral use

Spain

| Parke-Davis, S.L. (Pfizer Group) |
| --- |
| Av. de Europa 20-B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |

Parke-Davis, S.L. (Pfizer Group)

Av. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Lopid

900 mg

Tablets

Oral use

Sweden

| Pfizer AB |
| --- |
| Nytorpsvägen 36 |
| Box 501 |
| S–183 25 Täby |

Pfizer AB

Nytorpsvägen 36

Box 501

S–183 25 Täby

Lopid

300 mg

Capsules

Oral use

Sweden

| Pfizer AB |
| --- |
| Nytorpsvägen 36 |
| Box 501 |
| S–183 25 Täby |

Pfizer AB

Nytorpsvägen 36

Box 501

S–183 25 Täby

Lopid

450 mg

Film coated tablets

Oral use

Sweden

| Pfizer AB |
| --- |
| Nytorpsvägen 36 |
| Box 501 |
| S–183 25 Täby |

Pfizer AB

Nytorpsvägen 36

Box 501

S–183 25 Täby

Lopid

600 mg

Film coated tablets

Oral use

United Kingdom

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh,Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh,Hampshire SO53 3ZQ

United Kingdom

Lopid

300 mg

Capsules

Oral use

United Kingdom

| Warner Lambert UK Ltd trading as: |
| --- |
| Parke Davis |
| Lambert Court |
| Chestnut Avenue |
| Eastleigh,Hampshire SO53 3ZQ |
| United Kingdom |

Warner Lambert UK Ltd trading as:

Parke Davis

Lambert Court

Chestnut Avenue

Eastleigh,Hampshire SO53 3ZQ

United Kingdom

Lopid

600 mg

Film coated tablets

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY

| Member State | Marketing Authorisation Holder | Product trade name | Strength | Pharmaceutical form | Route of administration | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Mérial SAS |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Mérial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex – Lösung zum Auftragen auf die Haut für Rinder

5 mg/ml

Solution

Topical

Cattle

Belgium

| Merial Belgium NV/SA |
| --- |
| Bld Sylvain Dupuislaan 243 |
| B-1070 Bruxelles |
| Belgium |

Merial Belgium NV/SA

Bld Sylvain Dupuislaan 243

B-1070 Bruxelles

Belgium

EPRINEX POUR-ON

5 mg/ml

Solution for external use

Topical

Cattle including lactating cows

Denmark

| Merial Ltd. |
| --- |
| P.O. Box 327 |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| UK-Essex CM19 5TG |
| United Kingdom |

Merial Ltd.

P.O. Box 327

Sandringham House

Harlow Business Park

Harlow

UK-Essex CM19 5TG

United Kingdom

Eprinex Vet

5 mg/ml

Pour-on solution

Topical

Cattle

Finland

| Merial SAS |
| --- |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Merial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex pour-on vet

5 mg/ml

Pour-on solution

Topical

Cattle

France

| Mérial |
| --- |
| 29 av Tony Garnier |
| F-69007 Lyon |
| France |

Mérial

29 av Tony Garnier

F-69007 Lyon

France

EPRINEX pour on pour bovins

5 mg/ml

Cutaneous solution

Topical

Cattle

Germany

| Merial GmbH |
| --- |
| Am Söldnermoos 6 |
| D-85399 Hallbergmoos |
| Germany |

Merial GmbH

Am Söldnermoos 6

D-85399 Hallbergmoos

Germany

Eprinex Pour-on

0.5 g/100 ml

Solution

Topical

Cattle

Ireland

| Merial Ltd Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| UK-Essex CM19 5TG |
| United Kingdom |

Merial Ltd Limited

Sandringham House

Harlow Business Park

Harlow

UK-Essex CM19 5TG

United Kingdom

Eprinex Pour-On for beef and dairy cattle

0.5 % w/v

Pour-on solution

Topical

Beef and dairy cattle including lactating dairy cattle

Italy

| MERIAL ITALIA spa |
| --- |
| Milanofiori – Strada 6 |
| Palazzo E/5 |
| I-20090 Assago (MI) |
| Italy |

MERIAL ITALIA spa

Milanofiori – Strada 6

Palazzo E/5

I-20090 Assago (MI)

Italy

EPRINEX pour-on

5 mg/ml

Solution for external use

Topical

Beef and dairy cattle (including lactating cows)

Luxembourg

| Merial Belgium NV/SA |
| --- |
| Bvd Sylvain Dupuislaan 243 |
| B-1070 Bruxelles |
| Belgium |

Merial Belgium NV/SA

Bvd Sylvain Dupuislaan 243

B-1070 Bruxelles

Belgium

Eprinex Pour-on

5 mg/ml

Solution for external use

Topical

Cattle including lactating cows

The Netherlands

| Merial BV |
| --- |
| Bovenkerkerweg 6-8 |
| 1185 XE AMSTELVEEN |
| The Netherlands |

Merial BV

Bovenkerkerweg 6-8

1185 XE AMSTELVEEN

The Netherlands

Ivomec-Eprinex Pour On voor vlees- en melkvee

REGNL 9033

5 mg/ml

Solution

Topical

Cattle

Portugal

| Merial Portuguesa |
| --- |
| Saúde Animal Lda |
| Avenida Maria Lamas Lote 19 B1 A, piso 2 |
| Serra das Minas |
| P-2635-432 Rio de Mouro |
| Portugal |

Merial Portuguesa

Saúde Animal Lda

Avenida Maria Lamas Lote 19 B1 A, piso 2

Serra das Minas

P-2635-432 Rio de Mouro

Portugal

Eprinex Pour-On

5 mg/ml

Pour-on

Topical

Beef and dairy cattle

Spain

| Merial Laboratorios S.A. |
| --- |
| Tarragona 161 |
| E-08014 Barcelona |
| Spain |

Merial Laboratorios S.A.

Tarragona 161

E-08014 Barcelona

Spain

EPRINEX POUR ON

5 mg/ml

Solution

Topical

Cattle and dairy cows

Sweden

| Merial SAS |
| --- |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Merial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex Pour-on

5 mg/ml

Pour-on solution

Topical

Lactating and non-lactating cattle

United Kingdom

| Merial Ltd |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| UK-Essex CM19 5TG |
| United Kingdom |

Merial Ltd

Sandringham House

Harlow Business Park

Harlow

UK-Essex CM19 5TG

United Kingdom

Eprinex Pour-On for Beef and Dairy Cattle

0.5% w/v

Pour-on solution

Topical

Beef and dairy cattle including lactating dairy cattle

Norway

| Merial SAS |
| --- |
| 29 avenue Tony Garnier |
| F-69007 Lyon |
| France |

Merial SAS

29 avenue Tony Garnier

F-69007 Lyon

France

Eprinex pour-on vet

5 mg/ml

Cutaneous solution

Topical

Cattle (including lactating dairy cows)

---