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 or Article 38 of Directive 2001/82/EC)
Date: 2006-09-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical legislation, veterinary drug, withdrawal from the market

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))

(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

10.8.2006

Thelin

Encysive (UK) Limited
Alder Castle House
10 Noble Street
London EC2V 7QJ
United Kingdom

The Decision is sent
to
member
States.

all

21.8.2006

Prozac

See Annex II

21.8.2006

Cobactan IV 4;5%

See Annex III

21.8.2006

Ceftriaxone Tyrol
Pharma

See Annex IV

See Annex II

See Annex III

See Annex IV

28.8.2006

Exjade

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

The Decision is sent
member
to
States.

all

8.8.2006

11.8.2006

23.8.2006

23.8.2006

23.8.2006

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

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

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

ANNEX I

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

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

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

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

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

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

C

2
3
6
/
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Belgium

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

Neurontin

800 mg

Film-coated tablets

Oral use

.

.

3
0
9
2
0
0
6

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Cyprus

Cyprus

Denmark

Denmark

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

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

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

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

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

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

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

Pfizer Aps.
Lautrupvang 8
DK-2750 Ballerup

Pfizer Aps.
Lautrupvang 8
DK-2750 Ballerup

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Gabapentin ‘Pfizer’ 300 mg

Capsules, hard

Oral use

Gabapentin ‘Pfizer’ 400 mg

Capsules, hard

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
3
6
/
9

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Denmark

Denmark

Pfizer Aps.
Lautrupvang 8
DK-2750 Ballerup

Pfizer Aps.
Lautrupvang 8
DK-2750 Ballerup

Estonia

Estonia

Estonia

Estonia

Estonia

Finland

Finland

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

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

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

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

Gabapentin ‘Pfizer’ 600 mg

Film-coated tablets

Oral use

Gabapentin ‘Pfizer’ 800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

C

2
3
6
/
1
0

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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Finland

Finland

France

France

France

France

France

Germany

Germany

Germany

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

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

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

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

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

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

Parke-Davis GmbH
Pfizerstrasse 1
D-76139 Karlsruhe

Parke-Davis GmbH
Pfizerstrasse 1
D-76139 Karlsruhe

Parke-Davis GmbH
Pfizerstrasse 1
D-76139 Karlsruhe

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
1
1

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Greece

Greece

Greece

Greece

Greece

Iceland

Iceland

Parke-Davis GmbH
Pfizerstrasse 1
D-76139 Karlsruhe

Parke-Davis GmbH
Pfizerstrasse 1
D-76139 Karlsruhe

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

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

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

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

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

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

C

2
3
6
/
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Iceland

Iceland

Iceland

Ireland

Ireland

Ireland

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

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

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

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

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
1
3

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Ireland

Ireland

Hungary

Hungary

Hungary

Hungary

Hungary

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

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

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

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

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

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

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

C

2
3
6
/
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Latvia

Latvia

Latvia

Latvia

Latvia

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
1
5

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Lithuania

Lithuania

Lithuania

Lithuania

Lithuania

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Luxembourg

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

Luxembourg

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

Luxembourg

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

C

2
3
6
/
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Luxembourg

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

Luxembourg

Pfizer S.A.
Boulevard de la Plaine, 17
B-1050 Bruxelles

Malta

Malta

Malta

Malta

Norway

Norway

Norway

Norway

Norway

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

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

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

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

Pfizer AS
Postboks 3
N-1324 Lysaker

Pfizer AS
Postboks 3
N-1324 Lysaker

Pfizer AS
Postboks 3
N-1324 Lysaker

Pfizer AS
Postboks 3
N-1324 Lysaker

Pfizer AS
Postboks 3
N-1324 Lysaker

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
1
7

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Poland

Poland

Poland

Poland

Poland

Portugal

Portugal

Portugal

Portugal

Parke-Davis GmbH
Pfizerstr 1,
D-76139 Karlsruhe

Parke-Davis GmbH
Pfizerstr 1,
D-76139 Karlsruhe

Parke-Davis GmbH
Pfizerstr 1,
D-76139 Karlsruhe

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

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

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

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

C

2
3
6
/
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Portugal

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

Slovenia

Slovenia

Slovenia

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

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

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

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

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

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

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

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

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
1
9

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Slovenia

Slovenia

The
Republic

Slovak

The
Republic

Slovak

The
Republic

Slovak

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

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

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 Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Contact address:
Pfizer Luxembourg SARL
Branch office
Dubravska cesta 2,
SK-841 04 Bratislava

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Contact address:
Pfizer Luxembourg SARL
Branch office
Dubravska cesta 2,
SK-841 04 Bratislava

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

C

2
3
6
/
2
0

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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

The
Republic

Slovak

The
Republic

Slovak

Spain

Spain

Spain

Spain

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 Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Contact address:
Pfizer Luxembourg SARL
Branch office
Dubravska cesta 2,
SK-841 04 Bratislava

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

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

Neurontin

800 mg

Film-coated tablets

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
2
1

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Sweden

Sweden

Sweden

Sweden

Sweden

Pfizer AB
S-191 90 Sollentuna

Pfizer AB
S-191 90 Sollentuna

Pfizer AB
S-191 90 Sollentuna

Pfizer AB
S-191 90 Sollentuna

Pfizer AB
S-191 90 Sollentuna

Neurontin

100 mg

Capsules, hard

Oral use

Neurontin

300 mg

Capsules, hard

Oral use

Neurontin

400 mg

Capsules, hard

Oral use

Neurontin

600 mg

Film-coated tablets

Oral use

Neurontin

800 mg

Film-coated tablets

Oral use

United Kingdom Pfizer Ltd

Neurontin

100 mg

Capsules, hard

Oral use

Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

c/o Walton Oaks
Dorking Road
Tadworth
Surrey KT20 7NS

United Kingdom Pfizer Ltd

Neurontin

300 mg

Capsules, hard

Oral use

Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

c/o Walton Oaks
Dorking Road
Tadworth
Surrey KT20 7NS

United Kingdom Pfizer Ltd

Neurontin

400 mg

Capsules, hard

Oral use

Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

c/o Walton Oaks
Dorking Road
Tadworth
Surrey KT20 7NS

C

2
3
6
/
2
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

United Kingdom Pfizer Ltd

Neurontin

600 mg

Film-coated tablets

Oral use

Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

c/o Walton Oaks
Dorking Road
Tadworth
Surrey KT20 7NS

United Kingdom Pfizer Ltd

Neurontin

800 mg

Film-coated tablets

Oral use

Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

c/o Walton Oaks
Dorking Road
Tadworth
Surrey KT20 7NS

.

.

3
0
9
2
0
0
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

C
2
3
6
/
2
3

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

ANNEX II

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Austria

Belgium

Belgium

Belgium

Belgium

France

France

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

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

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

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

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

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

Fluctine

20 mg/5 ml

Oral solution

Oral use

Fluctine

20 mg

Capsule, hard

Oral use

Prozac

Prozac

Fontex

20 mg

Capsule, hard

Oral use

20 mg/5 ml

Oral solution

Oral use

20 mg

Capsule, hard

Oral use

Fluoxetine ‘Lilly’

20 mg

Capsule, hard

Oral use

Prozac

Prozac

20 mg

Capsule, hard

Oral use

20 mg/5 ml Oral solution

Oral use

C

2
3
6
/
2
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

France

France

Germany

Germany

Greece

Greece

Ireland

Ireland

Italy

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

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

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

Lilly Deutschland GmbH
Saalburgstr. 153
D-61350 Bad Homburg

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

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

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

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

Fluoxétine Lilly

20 mg

Capsule, hard

Oral use

Fluoxétine RPG

20 mg

Capsule, hard

Oral use

Fluctin

Fluctin

Ladose

Ladose

Prozac

20 mg

Capsule, hard

Oral use

20 mg/5 ml Oral solution

Oral use

20 mg/5 ml

Oral Solution

Oral use

20 mg

Capsule, hard

Oral use

20 mg/5 mg Oral solution

Oral use

Prozac

20 mg

Capsule, hard

Oral use

Prozac

20 mg/5 ml

Oral Solution

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
2
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Prozac

Prozac

Fontex

Prozac

Prozac

20 mg

Capsule, hard

Oral use

20 mg

Capsule, hard

Oral use

20 mg

Capsule, hard

Oral use

20 mg/5 ml Oral Solution

Oral use

20 mg

Capsule, hard

Oral use

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)

Luxembourg

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

Luxembourg

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

Luxembourg

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

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

Portugal

Portugal

Spain

Spain

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

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

Prozac

Prozac

20 mg/5 ml Oral solution

Oral use

20 mg

Capsule, hard

Oral use

C

2
3
6
/
2
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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Sweden

The Netherlands

The Netherlands

UK

UK

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

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

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

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

Fontex

Prozac

Prozac

Prozac

Prozac

20 mg/5 ml

Oral Solution

Oral use

20 mg/5 ml

Oral solution

Oral use

20 mg

Capsule, hard

Oral use

20 mg/5 ml

Oral Solution

Oral use

20 mg

Capsule, hard

Oral use

.

.

3
0
9
2
0
0
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

C
2
3
6
/
2
7

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

ANNEX III

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Austria

Belgium

Denmark

Intervet Gesmbh Siemens-
strasse 107
A-1210 Wien

Cobactan

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

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

Cobactan 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

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

Cobactan Vet.

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

C

2
3
6
/
2
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

Germany

Intervet Deutschland GmbH
Feldstr. 1a
D-85716 Unterschleissheim

Cobactan IV 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

Greece

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

Cobactan IV IM 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

.

.

3
0
9
2
0
0
6

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Spain

France

Hungary

Ireland

Italy

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

Cobactan 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

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

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

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

Cobactan IV IM 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

Cobactan IV 4.5 %
A.U.V.

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

Cephaguard IV IM 4.5
%

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

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

Cobactan 4.5 % IV IM

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

Luxembourg

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

Cobactan 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

.

.

3
0
9
2
0
0
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

C
2
3
6
/
2
9

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Netherlands

Poland

Portugal

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

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

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

Cobactan 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

Cobactan 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

Cobactan 4.5 %

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

Cephaguard IV IM 4.5
%

Powder and solvent
for solution for injec-
tion

45 mg/ml Horse

(adult

and foal)

Once or twice daily;
Intravenous and intra-
muscular use

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

C

2
3
6
/
3
0

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

.

.

3
0
9
2
0
0
6

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

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl

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Germany

Germany

Finland

Finland

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United Kingdom —

United Kingdom —

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

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

Sandoz Limited
Woolmer way
Bordon
Hants GU35 9QE
United Kingdom

Sandoz Limited
Woolmer way
Bordon
Hants GU35 9QE
United Kingdom

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

1 g

Powder for solution for injection
or infusion

Intramuscular and intravenous use

Ceftriaxon Tyrol Pharma 2 g
Pulver zur Herstellung einer Infu-
sionslösung

2 g

Powder for solution for infusion

Intravenous use

Lendacin 1 g injektio-/infuusio-
kuiva-aine
liuosta varten

1 g

Powder for solution for injection
or infusion

Intramuscular and intravenous use

Lendacin 2 g infuusiokuiva-aine
liuosta varten

2 g

Powder for solution for infusion

Intravenous use

Ceftriaxone 1 g powder for solu-
tion for injection/infusion

1 g

Powder for solution for injection
or infusion

Intramuscular and intravenous use

Ceftriaxone 2 g powder for solu-
tion for infusion

2 g

Powder for solution for infusion

Intravenous use

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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

Netherlands

Norway

Sweden

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

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

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

Cetirizine dihydrochloride Copyfarm 10 mg

10 mg

Filmcoated tablet

Cetirizin Copyfarm

10 mg

filmcoated tablet

Cetirizin Copyfarm

10 mg

Filmcoated tablet

Oral

Oral

Oral

Oral

C

2
3
6
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3
2

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N

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6