Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2007-06-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

29.6.2007

EN

Official Journal of the European Union

C 144/11

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 May 2007 to 31 May 2007

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

(2007/C 144/07)

— 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

22.5.2007

Doxyprex

See Annex I

See Annex I

22.5.2007

Thelin

This Decision is addressed
to the Member States

This Decision is addressed
to the Member States

29.5.2007

Xefo

See Annex II

See Annex II

30.5.2007

Remicade

This Decision is addressed
to the Member States

This Decision is addressed
to the Member States

— 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

2.5.2007

Alendros 70

See Annex III

See Annex III

Date of
notification

24.5.2007

24.5.2007

30.5.2007

31.5.2007

Date of
notification

4.5.2007

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

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

ANNEX I

Member State

Applicant or Marketing Authorisation
Holder

Product invented name

Pharmaceutical
form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Belgium, Czech Republic,
Germany, Greece, Spain,
France, Italy, The
Netherlands, Poland,
Portugal and Slovakia

Industrial Veterinaria, S.A.
Esmeralda, 19-4o
E-08950 Esplugues de Llobregat
(Barcelona)

DOXYPREX

Premix

100 mg/g

Pigs (after weaning)

In feed use

10 mg/kg .bw

C

1
4
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
9
6
2
0
0
7

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

ANNEX II

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Austria

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Artok

4 mg

Film-coated tablet

Oral

4 mg

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Lornox

4 mg

Film-coated tablet

Oral

4 mg

Xefo

4 mg

Film-coated tablet

Oral

4 mg

Artok

8 mg

Film-coated tablet

Oral

8 mg

Xefo

8 mg

Film-coated tablet

Oral

8 mg

Xefo Rapid

8 mg

Film-coated tablet

Oral

8 mg

Lornoxicam ‘Nycomed’

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Xefo

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

.

.

2
9
6
2
0
0
7

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
4
4
/
1
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Belgium

Bulgaria

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Czech Republic

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Xefo

Xefo

4 mg

Film-coated tablet

Oral

4 mg

8 mg

Film-coated tablet

Oral

8 mg

Xefo Acute

8 mg

Film-coated tablet

Oral

8 mg

Xefo

Xefo

Xefo

Xefo

Xefo

Xefo

Xefo

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg

Film-coated tablet

Oral

4 mg

8 mg

Film-coated tablet

Oral

8 mg

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg

Film-coated tablet

Oral

4 mg

8 mg

Film-coated tablet

Oral

8 mg

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

C

1
4
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
9
6
2
0
0
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Denmark

Estonia

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed SEFA
Jaama 55B
EE-63308 Pölva

Nycomed SEFA
Jaama 55B
EE-63308 Pölva

Nycomed SEFA
Jaama 55B
EE-63308 Pölva

Nycomed SEFA
Jaama 55B
EE-63308 Pölva

Lornoxicam ‘Nycomed’

4 mg

Film-coated tablet

Oral

Xefo

4 mg

Film-coated tablet

Oral

Lornoxicam ‘Nycomed’

8 mg

Film-coated tablet

Oral

Xefo

8 mg

Film-coated tablet

Oral

Xefo Rapid

8 mg

Film-coated tablet

Oral

4 mg

4 mg

8 mg

8 mg

8 mg

Lornoxicam ‘Nycomed’

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Xefo

Xefo

Xefo

4 mg

8 mg

Film-coated tablet

Oral

Film-coated tablet

Oral

Xefo Rapid

8 mg

Film-coated tablet

Oral

Xefo

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg

8 mg

8 mg

.

.

2
9
6
2
0
0
7

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
4
4
/
1
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Germany

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Lornoxicam ‘Nycomed’

4 mg

Film-coated tablet

Oral

Greece

Hungary

Nycomed Pharma GmbH
Edisonstraße 16
D-85716 Unterschleissheim

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Pharma GmbH
Edisonstraße 16
D-85716 Unterschleissheim

Nycomed Hellas S.A.
Λεωφ. Κηφισίας 196
GR-152 31 Αθήνα

Nycomed Hellas S.A.
Λεωφ. Κηφισίας 196
GR-152 31 Αθήνα

Nycomed Hellas S.A.
Λεωφ. Κηφισίας 196
GR-152 31 Αθήνα

Nycomed Hellas S.A.
Λεωφ. Κηφισίας 196
GR-152 31 Αθήνα

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Telos

4 mg

Film-coated tablet

Oral

Lornoxicam ‘Nycomed’

8 mg

Film-coated tablet

Oral

Telos

Xefo

Xefo

8 mg

4 mg

8 mg

Film-coated tablet

Oral

Film-coated tablet

Oral

Film-coated tablet

Oral

Xefo Rapid

8 mg

Film-coated tablet

Oral

4 mg

4 mg

8 mg

8 mg

4 mg

8 mg

8 mg

Xefo

Xefo

Xefo

Xefo

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg

8 mg

Film-coated tablet

Oral

Film-coated tablet

Oral

4 mg

8 mg

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

C

1
4
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
9
6
2
0
0
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Italy

Latvia

Lithuania

Nycomed Italy S.r.l.
Via Carducci 125
Edificio A
I-20099 Sesto San Giovanni

Nycomed Italy S.r.l.
Via Carducci 125
Edificio A
I-20099 Sesto San Giovanni

Nycomed Italy S.r.l.
Via Carducci 125
Edificio A
I-20099 Sesto San Giovanni

Nycomed Italy S.r.l.
Via Carducci 125
Edificio A
I-20099 Sesto San Giovanni

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed SEFA
Jaama 55B
EE-63308 Pölva

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed SEFA
Jaama 55B
EE-63308 Pölva

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Taigalor

8 mg

Film-coated tablet

Oral

Xefo

8 mg

Film-coated tablet

Oral

8 mg

8 mg

Taigalor

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Xefo

Xefo

Xefo

4 mg

8 mg

Film-coated tablet

Oral

Film-coated tablet

Oral

Xefo Rapid

8 mg

Film-coated tablet

Oral

Xefo

Xefo

Xefo

4 mg/ml

4 mg

8 mg

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Film-coated tablet

Oral

Film-coated tablet

Oral

Xefo Rapid

8 mg

Film-coated tablet

Oral

Xefo

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg

8 mg

8 mg

4 mg

8 mg

8 mg

.

.

2
9
6
2
0
0
7

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
4
4
/
1
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Luxembourg

Portugal

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Nycomed Christians
Gentsesteenweg 615
B-1080 Brussel

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Euro-Labor SA
Rua Alfredo da Silva n.o 16
P-2610-016 Amadora

Xefo

Xefo

4 mg

8 mg

Film-coated tablet

Oral

Film-coated tablet

Oral

Xefo Acute

8 mg

Film-coated tablet

Oral

4 mg

8 mg

8 mg

Xefo

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Acabel

4 mg

Film-coated tablet

Oral

Bosporon

4 mg

Film-coated tablet

Oral

Acabel

8 mg

Film-coated tablet

Oral

Bosporon

8 mg

Film-coated tablet

Oral

Acabel Rapid

8 mg

Film-coated tablet

Oral

Bosporon Rapid

8 mg

Film-coated tablet

Oral

4 mg

4 mg

8 mg

8 mg

8 mg

8 mg

Acabel

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Bosporon

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

C

1
4
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
9
6
2
0
0
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Romania

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Nycomed Austria GmbH
St. Peter Straße 25
A-4020 Linz

Xefo

Xefo

Xefo

4 mg

Film-coated tablet

Oral

8 mg

Film-coated tablet

Oral

4 mg

8 mg

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Spain

Laboratorios Andromaco S.A.
Doctor Zamenhof 36
E-29027 Madrid

Acabel

4 mg

Film-coated tablet

Oral

Bosporon

4 mg

Film-coated tablet

Oral

Acabel

8 mg

Film-coated tablet

Oral

Bosporon

8 mg

Film-coated tablet

Oral

Acabel Rapid

8 mg

Film-coated tablet

Oral

Bosporon Rapid

8 mg

Film-coated tablet

Oral

Tedec Meiji Farma, S.A.
Ctra. M-300
Km 30,500
E-28802 Alcalá de Henares, Madrid

Laboratorios Andromaco S.A.
Doctor Zamenhof 36
E-29027 Madrid

Tedec Meiji Farma, S.A.
Ctra. M-300
Km 30,500
E-28802 Alcalá de Henares, Madrid

Laboratorios Andromaco S.A.
Doctor Zamenhof 36
E-29027 Madrid

Tedec Meiji Farma, S.A.
Ctra. M-300
Km 30,500
E-28802 Alcalá de Henares, Madrid

Laboratorios Andromaco S.A.
Doctor Zamenhof 36
E-29027 Madrid

Acabel

4 mg/ml

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

4 mg

4 mg

8 mg

8 mg

8 mg

8 mg

.

.

2
9
6
2
0
0
7

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
4
4
/
1
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Sweden

United Kingdom

Nycomed AB
Tegeluddsvägen 17-21
S-102 53 Stockholm

Nycomed AB
Tegeluddsvägen 17-21
S-102 53 Stockholm

Nycomed AB
Tegeluddsvägen 17-21
S-102 53 Stockholm

Nycomed AB
Tegeluddsvägen 17-21
S-102 53 Stockholm

Nycomed UK Ltd
The Magdalen Centre Oxford Science Park
OX4 4GA Oxford
United Kingdom

Nycomed UK Ltd
The Magdalen Centre Oxford Science Park
OX4 4GA Oxford
United Kingdom

Nycomed UK Ltd
The Magdalen Centre Oxford Science Park
OX4 4GA Oxford
United Kingdom

Xefo

Xefo

Xefo Akut

Xefo

Xefo

Xefo

Xefo

4 mg

8 mg

8 mg

4 mg/ml

4 mg

8 mg

4 mg/ml

Film-coated tablet

Oral

Film-coated tablet

Oral

Film-coated tablet

Oral

4 mg

8 mg

8 mg

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

Film-coated tablet

Oral

Film-coated tablet

Oral

4 mg

8 mg

Powder and solvent
solution for injection

for

Intravenous use/Intramus-
cular use

8 mg

C

1
4
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
9
6
2
0
0
7

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

ANNEX III

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Zentiva, a.s.
U kabelovny 130
Dolní Měcholupy
CZ-102 37 Praha 10

Estonia

Hungary

Latvia

Lithuania

Poland

Slovakia

Zentiva, a.s.
U kabelovny 130
Dolní Měcholupy
CZ-102 37 Praha 10

Zentiva, a.s.
U kabelovny 130
Dolní Měcholupy
CZ-102 37 Praha 10

Zentiva, a.s.
U kabelovny 130
Dolní Měcholupy
CZ-102 37 Praha 10

Zentiva, a.s.
U kabelovny 130
Dolní Měcholupy
CZ-102 37 Praha 10

Zentiva, a.s.
U kabelovny 130
Dolní Měcholupy
CZ-102 37 Praha 10

Zentiva, a.s.
U kabelovny 130
Dolní Měcholupy
CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

Alendros 70

70 mg

Tablet

Oral use

Alendros 70

70 mg

Tablet

Oral use

Alendros 70

70 mg

Tablet

Oral use

Alendros 70

70 mg

Tablet

Oral use

Alendros 70

70 mg

Tablet

Oral use

Alendros 70

70 mg

Tablet

Oral use

.

.

2
9
6
2
0
0
7

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
4
4
/
2
1