Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 April 2006  to  30 April 2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2006-05-25
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

25.5.2006

EN

Official Journal of the European Union

C 124/11

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 April 2006 to 30 April 2006

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

(2006/C 124/04)

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

3.4.2006

Nifedipine

See Annex I

See Annex I

3.4.2006

Adartrel

See Annex II

See Annex II

4.4.2006

4.4.2006

10.4.2006

Prograf

See Annex III

See Annex III

12.4.2006

(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, ROUTES
OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

ANNEX I

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Belgium

Netherlands

United
Kingdom

Pharmamatch BV
Stationsweg Oost 281-D
3931 ER Woudenberg
The Netherlands

International Pharmaceutical
Services (IPS)
Jozef Nellenslei 10
B-2100 Deurne

Neolab Ltd.
57 High Street
Odiham
Hants
RG29 1LF
United Kingdom

Nifedipine TEVA 30/60 mg retard

30 mg/60 mg

prolonged-release tablets

Oral use

Nifedipine Pharmamatch retard
30/60 mg

30 mg/60 mg

prolonged-release tablets

Oral use

Neozipine XL 30/60 mg

30 mg/60 mg

prolonged-release tablets

Oral use

C

1
2
4
/
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
5
5
2
0
0
6

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

ANNEX II

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

.

.

2
5
5
2
0
0
6

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline, 100
Route de Versailles, F-78163
Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline, 100
Route de Versailles, F-78163
Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline, 100
Route de Versailles, F-78163
Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

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
1
2
4
/
1
3

MMember
state

Austria

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Cyprus

Cyprus

MMember
state

Cyprus

Cyprus

Czech
Republic

Czech
Republic

Czech
Republic

Czech
Republic

Denmark

Denmark

Denmark

Denmark

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

GlaxoSmithKline s.r.o.
Na Pankráci 17/1685
CZ-140 21 Praha 4

GlaxoSmithKline s.r.o.
Na Pankráci 17/1685
CZ-140 21 Praha 4

GlaxoSmithKline s.r.o.
Na Pankráci 17/1685
CZ-140 21 Praha 4

GlaxoSmithKline s.r.o.
Na Pankráci 17/1685
CZ-140 21 Praha 4

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

C

1
2
4
/
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
5
5
2
0
0
6

MMember
state

Estonia

Estonia

Estonia

Estonia

Finland

Finland

Finland

Finland

France

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

GlaxoSmithKline Oy
Piispansilta 9 A
FIN-02230 Espoo

GlaxoSmithKline Oy
Piispansilta 9 A
FIN-02230 Espoo

GlaxoSmithKline Oy
Piispansilta 9 A
FIN-02230 Espoo

GlaxoSmithKline Oy
Piispansilta 9 A
FIN-02230 Espoo

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

.

.

2
5
5
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
1
2
4
/
1
5

MMember
state

France

France

France

Germany

Germany

Germany

Germany

Greece

Greece

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline α.ε.β.ε
Κηφισίας 266, 152 32
Χαλάνδρι
Αθήνα
Ελλάδα

GlaxoSmithKline α.ε.β.ε
Κηφισίας 266, 152 32
Χαλάνδρι
Αθήνα
Ελλάδα

C

1
2
4
/
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
5
5
2
0
0
6

MMember
state

Greece

Greece

Hungary

Hungary

Hungary

Hungary

Iceland

Iceland

Iceland

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

GlaxoSmithKline α.ε.β.ε
Κηφισίας 266, 152 32
Χαλάνδρι
Αθήνα
Ελλάδα

GlaxoSmithKline α.ε.β.ε
Κηφισίας 266, 152 32
Χαλάνδρι
Αθήνα
Ελλάδα

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

.

.

2
5
5
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
1
2
4
/
1
7

MMember
state

Iceland

Ireland

Ireland

Ireland

Ireland

Italy

Italy

Italy

Italy

Latvia

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

C

1
2
4
/
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
5
5
2
0
0
6

MMember
state

Latvia

Latvia

Latvia

Lithuania

Lithuania

Lithuania

Lithuania

Luxembourg

Luxembourg

Luxembourg

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

.

.

2
5
5
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
1
2
4
/
1
9

MMember
state

Luxembourg

Malta

Malta

Malta

Malta

Netherlands

Netherlands

Netherlands

Netherlands

Norway

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

C

1
2
4
/
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

.

.

2
5
5
2
0
0
6

MMember
state

Norway

Norway

Norway

Poland

Poland

Poland

Poland

Portugal

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Beecham Portuguesa
Produtos Farmacêuticos e
Químicos, Lda.
Rua Dr. António Loureiro Borges,
n.o 3
Arquiparque — Miraflores
P-1495-131 Algés

.

.

2
5
5
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
1
2
4
/
2
1

MMember
state

Portugal

Portugal

Portugal

Slovakia

Slovakia

Slovakia

Slovakia

Slovenia

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Beecham Portuguesa
Produtos Farmacêuticos e
Químicos, Lda.
Rua Dr. António Loureiro Borges,
n.o 3
Arquiparque — Miraflores
P-1495-131 Algés

Beecham Portuguesa
Produtos Farmacêuticos e
Químicos, Lda.
Rua Dr. António Loureiro Borges,
n.o 3
Arquiparque — Miraflores
P-1495-131 Algés

Beecham Portuguesa
Produtos Farmacêuticos e
Químicos, Lda.
Rua Dr. António Loureiro Borges,
n.o 3
Arquiparque — Miraflores
P-1495-131 Algés

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

GSK d.o.o., Ljubljana
Knezov stradon 90
SLO-1000 Ljubljana

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

C

1
2
4
/
2
2

E
N

O

f
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l

J
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.

.

2
5
5
2
0
0
6

MMember
state

Slovenia

Slovenia

Slovenia

Spain

Spain

Spain

Spain

Sweden

Sweden

Sweden

Sweden

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

GSK d.o.o., Ljubljana
Knezov stradon 90
SLO-1000 Ljubljana

GSK d.o.o., Ljubljana
Knezov stradon 90
SLO-1000 Ljubljana

GSK d.o.o., Ljubljana
Knezov stradon 90
SLO-1000 Ljubljana

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

.

.

2
5
5
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
1
2
4
/
2
3

MMember
state

UK

UK

UK

UK

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of
administration

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100 Route de Versailles
F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

ADARTREL

0,5 mg

Film-coated tablet

Oral use

ADARTREL

1,0 mg

Film-coated tablet

Oral use

ADARTREL

2,0 mg

Film-coated tablet

Oral use

C

1
2
4
/
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

.

.

2
5
5
2
0
0
6

25.5.2006

EN

Official Journal of the European Union

C 124/25

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

ANNEX III

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Cyprus

Cyprus

Cyprus

Astellas Pharma Ges.m.b.H
Linzerstr. 221-227
A-1140 Wien

Astellas Pharma Ges.m.b.H
Linzerstr. 221-227
A-1140 Wien

Astellas Pharma Ges.m.b.H
Linzerstr. 221-227
A-1140 Wien

Astellas Pharma Ges.m.b.H
Linzerstr. 221-227
A-1140 Wien

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Medilink Pharmaceuticals Ltd.
30 Armenias
P.O. Box 25676
2003 Strovolos
1640 Nikosia
Cyprus

Medilink Pharmaceuticals Ltd.
30 Armenias
P.O. Box 25676
2003 Strovolos
1640 Nikosia
Cyprus

Medilink Pharmaceuticals Ltd.
30 Armenias
P.O. Box 25676
2003 Strovolos
1640 Nikosia
Cyprus

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenoius use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograft

0,5 mg

Hard Capsules

Oral use

Prograft

1 mg

Hard Capsules

Oral use

Prograft

5 mg

Hard Capsules

Oral use

Prograft

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Czech Republic

Astellas Pharma s.r.o
Meteor Office Centre Park
Sokolovská 100/94
CZ-186 00 Praha 8

Prograf

0,5 mg

Hard Capsules

Oral use

C 124/26

EN

Official Journal of the European Union

25.5.2006

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Czech Republic

Czech Republic

Germany

Germany

Germany

Germany

Denmark

Denmark

Denmark

Denmark

Greece

Greece

Greece

Astellas Pharma s.r.o
Meteor Office Centre Park
Sokolovská 100/94
CZ-186 00 Praha 8

Astellas Pharma s.r.o
Meteor Office Centre Park
Sokolovská 100/94
CZ-186 00 Praha 8

Astellas Pharma s.r.o
Meteor Office Centre Park
Sokolovská 100/94
CZ-186 00 Praha 8

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Vianex S.A.
Tatoiou Street
Lamia National Road
EL-14671 Nea Erythrea

Vianex S.A.
Tatoiou Street
Lamia National Road
EL-14671 Nea Erythrea

Vianex S.A.
Tatoiou Street
Lamia National Road
EL-14671 Nea Erythrea

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

25.5.2006

EN

Official Journal of the European Union

C 124/27

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical Form

Route of administration

Greece

Spain

Spain

Spain

Spain

Finland

Finland

Finland

Finland

France

France

France

France

Vianex S.A.
Tatoiou Street
Lamia National Road
EL-14671 Nea Erythrea

Astellas Pharma S.A.
Paseo del Club Deportivo
no 1, Bloque 14
E-28223 Pozuelo de Alarcón
(Madrid)

Astellas Pharma S.A.
Paseo del Club Deportivo
no 1, Bloque 14
E-28223 Pozuelo de Alarcón
(Madrid)

Astellas Pharma S.A.
Paseo del Club Deportivo
no 1, Bloque 14
E-28223 Pozuelo de Alarcón
(Madrid)

Astellas Pharma S.A.
Paseo del Club Deportivo
no 1, Bloque 14
E-28223 Pozuelo de Alarcón
(Madrid)

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma S.A.S.
114 rue Victor Hugo
F-92300 Levallois Perret

Astellas Pharma S.A.S.
114 rue Victor Hugo
F-92300 Levallois Perret

Astellas Pharma S.A.S.
114 rue Victor Hugo
F-92300 Levallois Perret

Astellas Pharma S.A.S.
114 rue Victor Hugo
F-92300 Levallois Perret

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Hungary

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Prograf

0,5 mg

Hard Capsules

Oral use

C 124/28

EN

Official Journal of the European Union

25.5.2006

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical Form

Route of administration

Hungary

Hungary

Hungary

Ireland

Ireland

Ireland

Ireland

Italy

Italy

Italy

Italy

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma Co. Ltd.
25, The Courtyard
Kilcarbery Business Park
Clondalkin, Dublin 22
Ireland

Astellas Pharma Co. Ltd.
25, The Courtyard
Kilcarbery Business Park
Clondalkin, Dublin 22
Ireland

Astellas Pharma Co. Ltd.
25, The Courtyard
Kilcarbery Business Park
Clondalkin, Dublin 22
Ireland

Astellas Pharma Co. Ltd.
25, The Courtyard
Kilcarbery Business Park
Clondalkin, Dublin 22
Ireland

Astellas Pharma S.p.A
Via delle Industrie 1
I-20061 Carugate (Milano)

Astellas Pharma S.p.A
Via delle Industrie 1
I-20061 Carugate (Milano)

Astellas Pharma S.p.A
Via delle Industrie 1
I-20061 Carugate (Milano)

Astellas Pharma S.p.A
Via delle Industrie 1
I-20061 Carugate (Milano)

Luxembourg

Luxembourg

Luxembourg

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograft

0,5 mg

Hard Capsules

Oral use

Prograft

1 mg

Hard Capsules

Oral use

Prograft

5 mg

Hard Capsules

Oral use

25.5.2006

EN

Official Journal of the European Union

C 124/29

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical Form

Route of administration

Luxembourg

The Netherlands

The Netherlands

The Netherlands

The Netherlands

Norway

Norway

Norway

Norway

Poland

Poland

Poland

Poland

Portugal

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma B.V.
Postbus 108
2350 AC Leiderdorp
The Netherlands

Astellas Pharma B.V.
Postbus 108
2350 AC Leiderdorp
The Netherlands

Astellas Pharma B.V.
Postbus 108
2350 AC Leiderdorp
The Netherlands

Astellas Pharma B.V.
Postbus 108
2350 AC Leiderdorp
The Netherlands

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Astellas Farma Limitada
Edifício Cinema
Rua José Fontana, n°1, 1o
andar
P-2770-101 Paço de Arcos

Prograft

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograft

0,5 mg

Hard Capsules

Oral use

Prograft

1 mg

Hard Capsules

Oral use

Prograft

5 mg

Hard Capsules

Oral use

Prograft

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

0,5 mg

Hard Capsules

Oral use

C 124/30

EN

Official Journal of the European Union

25.5.2006

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical Form

Route of administration

Portugal

Portugal

Portugal

Slovakia

Slovakia

Slovakia

Slovenia

Slovenia

Sweden

Sweden

Sweden

Sweden

Astellas Farma Limitada
Edifício Cinema
Rua José Fontana, n°1, 1o
andar
P-2770-101 Paço de Arcos

Astellas Farma Limitada
Edifício Cinema
Rua José Fontana, n°1, 1o
andar
P-2770-101 Paço de Arcos

Astellas Farma Limitada
Edifício Cinema
Rua José Fontana, n°1, 1o
andar
P-2770-101 Paço de Arcos

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

Fujisawa GmbH
Neumarkter Str. 61
D-81673 München

PharmaSwiss d.o.o.
Wolfova 1
SLO-1000 Ljubljana

PharmaSwiss d.o.o.
Wolfova 1
SLO-1000 Ljubljana

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Astellas Pharma a/s
Naverland 4
DK-2600 Glostrup

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

0,5 mg

Hard Capsules

Oral use

Prograf

1 mg

Hard Capsules

Oral use

Prograf

5 mg

Hard Capsules

Oral use

Prograf

5 mg/ml

Concentrate for Solution for
Infusion

Intravenous use

United Kingdom Astellas Pharma Ltd.

Prograf

0,5 mg

Hard Capsules

Oral use

Lovett House, Lovett Road
Staines
Middlesex, TW18 3AZ
United Kingdom

25.5.2006

EN

Official Journal of the European Union

C 124/31

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical Form

Route of administration

United Kingdom Astellas Pharma Ltd.

Prograf

1 mg

Hard Capsules

Oral use

Lovett House, Lovett Road
Staines
Middlesex, TW18 3AZ
United Kingdom

United Kingdom Astellas Pharma Ltd.

Prograf

5 mg

Hard Capsules

Oral use

Lovett House, Lovett Road
Staines
Middlesex, TW18 3AZ
United Kingdom

United Kingdom Astellas Pharma Ltd.

Prograf

5 mg/ml

Lovett House, Lovett Road
Staines
Middlesex, TW18 3AZ
United Kingdom

Concentrate for Solution for
Infusion

Intravenous use