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 or Article 38 of Directive 2001/82/EC)
Date: 2004-08-27
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

27.8.2004

EN

Official Journal of the European Union

C 215/11

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))

(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

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

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

ANNEX I

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Belgium

Belgium

Belgium

Denmark

Denmark

Denmark

Finland

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

450 mg

Film coated tablets

Oral use

Gevillon

900 mg

Film coated tablets

Oral use

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

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

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

Pfizer ApS
Lautrupvang 8
DK–2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK–2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK–2750 Ballerup

Pfizer Oy
P.O. Box 45
FIN–02601 Espoo

Lopid

Lopid

Lopid

Lopid

Lopid

Lopid

Lopid

300 mg

Capsules

Oral use

600 mg

Film-coated tablets

Oral use

900 mg

Film-coated tablets

Oral use

300 mg

Capsules

Oral use

450 mg

Film-coated tablets

Oral use

600 mg

Film-coated tablets

Oral use

300 mg

Capsules

Oral use

C

2
1
5
/
1
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
7
8
2
0
0
4

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

France

Germany

Germany

Germany

Germany

Germany

Greece

Greece

Pfizer Oy
P.O. Box 45
FIN–02601 Espoo

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

Lopid

Lipur

600 mg

Film-coated tablets

Oral use

450 mg

Film-coated tablets

Oral use

Parke-Davis GmbH
Pfizerstrasse 1
D–76139 Karlsruhe

Parke-Davis GmbH
Pfizerstrasse 1
D–76139 Karlsruhe

Parke-Davis GmbH
Pfizerstrasse 1
D–76139 Karlsruhe

Parke-Davis GmbH
Pfizerstrasse 1
D–76139 Karlsruhe

Parke-Davis GmbH
Pfizerstrasse 1
D–76139 Karlsruhe

Pfizer Hellas A.E.
Alketou Street 5
Athens

Pfizer Hellas A.E.
Alketou Street 5
Athens

Gevilon

450 mg

Film-coated tablets

Oral use

Gevilon

600 mg

Film-coated tablets

Oral use

Gevilon uno

900 mg

Film-coated tablets

Oral use

Continulipid

450 mg

Film-coated tablets

Oral use

Continulipid

600 mg

Film-coated tablets

Oral use

Lopid

Lopid

600 mg

Film-coated tablets

Oral use

900 mg

Film-coated tablets

Oral use

.

.

2
7
8
2
0
0
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
2
1
5
/
1
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Iceland

Iceland

Iceland

Ireland

Ireland

Italy

Italy

Italy

Pfizer ApS
Lautrupvang 8
DK–2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK–2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK–2750 Ballerup

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

Pfizer Italia S.r.l.
Via Valbondione 113
I–00188 Roma

Pfizer Italia S.r.l.
Via Valbondione 113
I–00188 Roma

Pfizer Italia S.r.l.
Via Valbondione 113
I–00188 Roma

Lopid

Lopid

Lopid

Lopid

300 mg

Capsules

Oral use

450 mg

Film-coated tablets

Oral use

600 mg

Film-coated tablets

Oral use

300 mg

Capsules

Oral use

Lopid

600 mg

Film coated tablets

Oral use

Lopid

Lopid

600 mg

Tablets

Oral use

900 mg

Tablets

Oral use

Lopid TC

900 mg

Granules

Oral use

C

2
1
5
/
1
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
7
8
2
0
0
4

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Lopid TC

1200 mg

Granules

Oral use

.

.

2
7
8
2
0
0
4

Italy

Pfizer Italia S.r.l.
Via Valbondione 113
I–00188 Roma

Luxembourg

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

Luxembourg

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

Luxembourg

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

Netherlands

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

Netherlands

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

Lopid

Lopid

Lopid

Lopid

Lopid

Portugal

Portugal

Portugal

Laboratórios Pfizer, Lda., Lagoas Park -
Edifício n° 10
2740-244 Porto Salvo

Lopid

Laboratórios Pfizer, Lda., Lagoas Park -
Edifício n° 10
2740-244 Porto Salvo

Lopid

Laboratórios Pfizer, Lda., Lagoas Park -
Edifício n° 10
2740-244 Porto Salvo

Lopid

300 mg

Capsules

Oral use

600 mg

Film-coated tablets

Oral use

900 mg

Film-coated tablets

Oral use

600 mg

Coated tablets

Oral use

900 mg

Coated tablets

Oral use

300 mg

Capsules

Oral use

600 mg

Coated tablets

Oral use

900 mg

Coated tablets

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
2
1
5
/
1
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Spain

Spain

Sweden

Sweden

Sweden

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)

Pfizer AB
Nytorpsvägen 36
Box 501
S–183 25 Täby

Pfizer AB
Nytorpsvägen 36
Box 501
S–183 25 Täby

Pfizer AB
Nytorpsvägen 36
Box 501
S–183 25 Täby

Lopid

Lopid

Lopid

Lopid

Lopid

600 mg

Tablets

Oral use

900 mg

Tablets

Oral use

300 mg

Capsules

Oral use

450 mg

Film coated tablets

Oral use

600 mg

Film coated tablets

Oral use

United Kingdom Warner Lambert UK Ltd trading as:

Lopid

300 mg

Capsules

Oral use

Parke Davis
Lambert Court
Chestnut Avenue
Eastleigh,Hampshire SO53 3ZQ
United Kingdom

United Kingdom Warner Lambert UK Ltd trading as:

Lopid

600 mg

Film coated tablets

Oral use

Parke Davis
Lambert Court
Chestnut Avenue
Eastleigh,Hampshire SO53 3ZQ
United Kingdom

C

2
1
5
/
1
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
7
8
2
0
0
4

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

ANNEX II

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Belgium

Denmark

Finland

France

Germany

Ireland

Mérial SAS
29 avenue Tony Garnier
F-69007 Lyon
France

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

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

Merial SAS
29 avenue Tony Garnier
F-69007 Lyon
France

Mérial
29 av Tony Garnier
F-69007 Lyon
France

Merial GmbH
Am Söldnermoos 6
D-85399 Hallbergmoos
Germany

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

–

Lösung

Eprinex
Auftragen auf die Haut
Rinder

5 mg/ml

Solution

Topical

Cattle

zum
für

EPRINEX POUR-ON

5 mg/ml

Solution for external use

Topical

Cattle including lactating cows

Eprinex Vet

5 mg/ml

Pour-on solution

Topical

Cattle

Eprinex pour-on vet

5 mg/ml

Pour-on solution

Topical

Cattle

EPRINEX pour on pour bovins 5 mg/ml

Cutaneous solution

Topical

Cattle

Eprinex Pour-on

0.5 g/100 ml

Solution

Topical

Cattle

Eprinex Pour-On for beef and
dairy cattle

0.5 % w/v

Pour-on solution

Topical

Beef and dairy cattle including
lactating dairy cattle

.

.

2
7
8
2
0
0
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
2
1
5
/
1
7

Member State

Marketing Authorisation Holder

Product trade name

Strength

Pharmaceutical form

Route of administration

Animal species

Italy

Luxembourg

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

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

The Netherlands Merial BV

Portugal

Spain

Sweden

Bovenkerkerweg 6-8
1185 XE AMSTELVEEN
The Netherlands

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

Merial SAS
29 avenue Tony Garnier
F-69007 Lyon
France

United Kingdom Merial Ltd

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

Merial SAS
29 avenue Tony Garnier
F-69007 Lyon
France

Norway

EPRINEX pour-on

5 mg/ml

Solution for external use

Topical

Beef and dairy cattle (including
lactating cows)

Eprinex Pour-on

5 mg/ml

Solution for external use

Topical

Cattle including lactating cows

Ivomec-Eprinex Pour On voor
vlees- en melkvee
REGNL 9033

5 mg/ml

Solution

Topical

Cattle

Eprinex Pour-On

5 mg/ml

Pour-on

Topical

Beef and dairy cattle

EPRINEX POUR ON

5 mg/ml

Solution

Topical

Cattle and dairy cows

Eprinex Pour-on

5 mg/ml

Pour-on solution

Topical

Lactating and non-lactating cattle

Eprinex Pour-On for Beef and
Dairy Cattle

0.5% w/v

Pour-on solution

Topical

Beef and dairy cattle including
lactating dairy cattle

Eprinex pour-on vet

5 mg/ml

Cutaneous solution

Topical

Cattle (including lactating dairy
cows)

C

2
1
5
/
1
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
7
8
2
0
0
4