Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2008-03-28
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

28.3.2008

EN

Official Journal of the European Union

C 77/9

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 February 2008 to 29 February 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1)
or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2))

(2008/C 77/03)

— 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

5.1.2008

Carisoprodol

15.2.2008

Aprotinin

See Annex I

See Annex II

See Annex I

See Annex II

15.2.2008

Simvastatin Krka

See Annex III

See Annex III

Date of
notification

6.2.2008

19.2.2008

19.2.2008

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

ANNEX I

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

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of
administration

Czech Republic

Denmark

Finland

Greece

Greece

Greece

Hungary

Iceland

Iceland

Italy

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest

Actavis Group hf
Reykjavíkurvegur 76-78
IS-220 Hafnafjördur

Actavis Group hf.
Reykjavíkurvegi 76-78
IS-220 Hafnafjördur

Uni Pharma Kleon Tsetis Pharmaceutical
Laboratories ABEE
14 km National Highway Athens-Lamia
GR-14564 K. Kifissia

Uni Pharma Kleon Tsetis Pharmaceutical
Laboratories ABEE
14 km National Highway Athens-Lamia
GR-14564 K. Kifissia

Uni Pharma Kleon Tsetis Pharmaceutical
Laboratories ABEE
14 km National Highway Athens-Lamia
GR-14564 K. Kifissia

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest

Actavis Group hf.
Reykjavíkurvegi 76-78
IS-220 Hafnarfjörður

Actavis Group hf.
Reykjavíkurvegi 76-78
IS-220 Hafnarfjörður

TEOFARMA Srl
Sede legale: via F.lli Cervi, 8
I-27010 Valle Salimbene (PV)

Scutamil C

150 mg carisoprodol/100 mg paracetamol

Coated tablet

Oral use

Somadril

350 mg

Film coated tablet

Oral use

Somadril Comp

200 mg carisoprodol/160 mg paracetamol/32 mg
caffeine

Film coated tablet

Oral use

Artifar

350 mg

Film coated tablet

Oral use

Relacton-C

200 mg carisoprodol/300 mg paracetamol

Tablet

Oral use

Relacton-C

400 mg carisoprodol/600 mg paracetamol

Suppository

Rectal use

Scutamil-C

150 mg carisoprodol,
100 mg paracetamol

Tablet

Oral use

Somadril

350 mg

Film coated tablet

Oral use

Somadril Comp

200 mg carisoprodol/160 mg paracetamol

Film coated tablet

Oral use

Soma complex

140 mg carisoprodol/500 mg metamizole sodium Film coated tablet

Oral use

C

7
7
/
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

.

.

2
8
3
2
0
0
8

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of
administration

Italy

Norway

Slovak Republic

Spain

Spain

Sweden

Sweden

United Kingdom

United Kingdom

TEOFARMA Srl
Sede legale: via F.lli Cervi, 8
I-27010 Valle Salimbene (PV)

Actavis Group hf.
Reykjavíkurvegi 76-78
IS-220 Hafnarfjörður

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest

Laboratorios BELMAC SA
Teide, 4-planta baj. Polígono Empresarial
La Marina
E-28700 San Sebastian de los Reyes
Madrid

Laboratorios Rimafar
Polígono industrial Malpica
c, no 4
E-50057 Zaragoza

Actavis Group hf
Reykjavíkurvegur 76-78
IS-220 Hafnafjördur

Actavis Group hf
Reykjavíkurvegur 76-78
IS-220 Hafnafjördur

Forest Laboratories UK Limited
Bourne Road
Bexley
Kent DA5 1NX
United Kingdom

Forest Laboratories UK Limited
Bourne Road
Bexley
Kent DA5 1NX
United Kingdom

Soma complex

600 mg
sodium

carisoprodol/1 000 mg metamizole

Suppository

Rectal use

Somadril

350 mg

Film coated tablet

Oral use

Scutamil C

150 mg carisoprodol/100 mg paracetamol

Film coated tablet

Oral use

Mio Relax

350 mg

Tablet

Oral use

Relaxibys

200 mg carisoprodol/500 mg paracetamol

Tablet

Oral use

Somadril

350 mg

Tablet

Oral use

Somadril comp.

200 mg carisoprodol/160 mg paracetamol/32 mg
caffeine

Tablet

Oral use

Carisoma

125 mg

Tablet

Oral use

Carisoma

350 mg

Tablet

Oral use

.

.

2
8
3
2
0
0
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

C

7
7
/
1
1

ANNEX II

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

Aprotinin containing medicinal products with marketing authorisation in the European Union

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Austria

Austria

Austria

Belgium

Belgium

Bulgaria

Bulgaria

Bulgaria

Gerot Pharmazeutika Gesellschaft m.b.H.
Arnethgasse 3
A-1160 Wien

Gerot Pharmazeutika Gesellschaft m.b.H.
Arnethgasse 3
A-1160 Wien

Gerot Pharmazeutika Gesellschaft m.b.H.
Arnethgasse 3
A-1160 Wien

Bayer Austria GmbH
Herbststraße 6-10
A-1160 Wien

Bayer NV
Avenue Louise 143
B-1050 Bruxelles

Bayer NV
Avenue Louise 143
B-1050 Bruxelles

Gedeon Richter Plc.
Gyömrői út 19-21
H-1103 Budapest

Gedeon Richter Plc.
Gyömrői út 19-21
H-1103 Budapest

Bayer AG
D-51368 Leverkusen

Pantinol

100 000 KIU/10 ml

Solution for injection and solution for infu-
sion

Intravenous use

Pantinol

200 000 KIU/10 ml

Solution for injection and solution for infu-
sion

Intravenous use

Pantinol

500 000 KIU/15 ml

Solution for injection and solution for infu-
sion

Intravenous use

Trasylol 10 000 KIU/ml

500 000 KIU/50 ml

Solution for injection and solution for infu-
sion

Intravenous use

Trasylol

20 000 KIU/ml

Solution

Intravenous use

Trasylol

10 000 KIU/ml

Solution

Intravenous use

Gordox

100 000 KIU

Solution for injection

Intravenous use

Gordox

500 000 KIU

Solution for infusion

Intravenous use

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

C

7
7
/
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
8
3
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Cyprus

Czech Republic

Czech Republic

Bayer Hellas Abee
Σορού 18-20/Sorou 18-20
GR-15125 Μαρούσι-Αθήνα
GR-15125 Marousi-Athens

Spofa a. s.
Poděbradská 5
CZ-180 47 Praha 9

Chemical Works of Gedeon Richter Ltd.
Gyömrői út 19-21
H-1103 Budapest

Czech Republic

Bayer HealthCare AG
D-51368 Leverkusen

Denmark

Bayer HealthCare AG
D-51368 Leverkusen

Estonia

Finland

France

France

France

Gedeon Richter Ltd
Gyömrői út 19-21
H-1103 Budapest

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Pharma SA
13, rue Jean Jaurès
F-92807 Puteaux Cedex

Bayer Pharma SA
13, rue Jean Jaurès
F-92807 Puteaux Cedex

Bayer Pharma SA
13, rue Jean Jaurès
F-92807 Puteaux Cedex

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

Antilysin Spofa

55,55 Ph.Eur.U./10 ml

Solution for injection

Intravenous use

Gordox

60 Ph.Eur.U./10 ml

Solution for injection

Intravenous use

Trasylol 500 000 KIU

70 mg

Solution for infusion

Intravenous use

Trasylol

10 000 KIU/ml

Solution for injection

Intravenous use

Gordox

10 000 KIU/50 ml

Concentrate for solution for infusion

Intravenous use

Trasylol

10 000 KIU/ml

Solution for injection and solution for infu-
sion

Intravenous use

Trasylol

1 000 000 KIU/100 ml

Solution for injection

Intravenous use

Trasylol

2 000 000 KIU/200 ml

Solution for injection

Intravenous use

Trasylol

500 000 KIU/50 ml

Solution for injection

Intravenous use

Germany

Bayer HealthCare AG
D-51368 Leverkusen

Trasynin 0,5

70,0 mg/50 ml

Solution for infusion

Intravenous use

.

.

2
8
3
2
0
0
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

C

7
7
/
1
3

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Greece

Hungary

Hungary

Hungary

Latvia

Latvia

Latvia

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Vital GmbH
D-51368 Leverkusen

Bayer Vital GmbH
D-51368 Leverkusen

Bayer Vital GmbH
D-51368 Leverkusen

EMRA-MED Arzneimittel GmbH
Otto-Han-Str. 11
D-22946 Trittau

Bayer Hellas Abee
Σορού 18-20/Sorou 18-20
GR-15125 Μαρούσι-Αθήνα
GR-15125 Marousi-Athens

Bayer Hungária Kft
Alkotás u. 50.
H-1123 Budapest

Richter Gedeon NyRt.
Gyömrői út 19-21.
H-1103 Budapest

Richter Gedeon NyRt.
Gyömrői út 19-21.
H-1103 Budapest

Bayer Healthcare AG
D-51368 Leverkusen

Bayer Healthcare AG
D-51368 Leverkusen

Bayer Healthcare AG
D-51368 Leverkusen

Trasynin 1,0

140,0 mg/100 ml

Solution for infusion

Intravenous use

Trasynin 2,0

280,0 mg/200 ml

Solution for infusion

Intravenous use

Trasylol 0,5

70,0 mg/50 ml

Solution for infusion

Intravenous use

Trasylol 1,0

140,0 mg/100 ml

Solution for infusion

Intravenous use

Trasylol 2,0

280,0 mg/200 ml

Solution for infusion

Intravenous use

Trasylol 0,5

70,0 mg/50 ml

Solution for infusion

Intravenous use

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

Trasylol

500 000 KIU

Solution for infusion

Intravenous use

Gordox

500 000 KIU

Solution for infusion

Intravenous use

Gordox

100 000 KIU

Solution for injection

Intravenous use

Trasylol 0,5

10 000 KIU/ml

Solution for injection

Intravenous use

Trasylol 1,0

10 000 KIU/ml

Solution for injection

Intravenous use

Trasylol 2,0

10 000 KIU/ml

Solution for injection

Intravenous use

C

7
7
/
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
8
3
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Latvia

Lithuania

Luxembourg

Gedeon Richter Ltd.
Gyömrői út 19-21
H-1103 Budapest

Gedeon Richter Ltd.
Gyömrői út 19-21
H-1103 Budapest

Bayer S.A
143, avenue Louise
B-1050 Bruxelles

Malta

Malta

Malta

Malta

Bayer plc Pharmaceutical Division
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc Pharmaceutical Division
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc Pharmaceutical Division
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc Pharmaceutical Division
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Gordox

10 000 KIU/ml

Solution for injection

Intravenous use

Gordox

10 000 KIU/ml

Solution for injection

Intravenous use

Trasylol

500 000 KIU/50 ml

Solution for injection

Intravenous use/subcuta-
neous use

Trasylol

500 000 KIU (50 ml vial)

Solution for infusion

Intravenous use

Trasylol

1 000 000 KIU (100 ml
vial)

Solution for infusion

Intravenous use

Trasylol

2 000 000 KIU (200 ml
vial)

Solution for infusion

Intravenous use

Trasylol

10 000 KIU/ml

Solution for infusion

Intravenous use

Netherlands

Bayer B.V.
Postbus 80
3640 AB Mijdrecht
Nederland

Trasylol

10 000 KIU/ml

Solution for infusion

Intravenous use

.

.

2
8
3
2
0
0
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

C

7
7
/
1
5

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Poland

Poland

Poland

Poland

Portugal

Portugal

Portugal

Romania

Romania

Slovakia

Slovakia

Slovenia

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
PL-58-500 Jelenia Góra

Traskolan

500 000 KIU/10 ml

Solution for injection

Intravenous use

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Portugal, S.A. PRT
Rua Quinta do Pinheiro, 5
P-2794-003 Carnaxide

Bayer Portugal, S.A. PRT
Rua Quinta do Pinheiro, 5
P-2794-003 Carnaxide

Bayer Portugal, S.A. PRT
Rua Quinta do Pinheiro, 5
P-2794-003 Carnaxide

Bayer HealthCare AG
D-51368 Leverkusen

Gedeon Richter Ltd.
Győmrői ut 19-21
H-1103 Budapest

SPOFA a. s.
Husinecká 11a
CZ-130 00 Praha 3

Gedeon Richter Ltd.
Győmrői ut 19-21
H-1103 Budapest

Bayer d.o.o.
Bravničarjeva 13
SLO-1000 Ljubljana

Trasylol

277,8 Ph.Eur.U.

Solution for infusion

Intravenous use

Trasylol

555,6 Ph.Eur.U.

Solution for infusion

Intravenous use

Trasylol

1 111,1 Ph.Eur.U.

Solution for infusion

Intravenous use

Trasylol

500 000 KIU/50 ml

Solution for infusion

Intravenous use

Trasylol

1 000 000 KIU/100 ml

Solution for infusion

Intravenous use

Trasylol

2 000 000 KIU/200 ml

Solution for infusion

Intravenous use

Trasylol

500 000 KIU

Solution for infusion

Intravenous use

Gordox

100 000 KIU

Solution for injection

Intramuscular use

Antilysin Spofa

100 000 KIU/10 ml

Solution for injection

Intravenous use

Gordox

100 000 KIU/10 ml

Solution for injection

Intravenous use

Trasylol

10 000 KIU/ml

Solution for injection and solution for infu-
sion

Intravenous use

C

7
7
/
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
8
3
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Sweden

United Kingdom

United Kingdom

Bayer HealthCare AG
D-51368 Leverkusen

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Nordic Pharma Limited
Abbey House
1650 Arlington Business Park
Theale, Reading
Berkshire RG7 4SA
United Kinddom

Trasylol

Trasylol

10 000 KIU/ml

Solution for injection and solution for infu-
sion

Intravenous use

10 000 KIU/ml

Solution for injection

Intravenous use

Aprotinine

10 000 KIU/ml

Solution for injection

Intravenous use

ANNEX III

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER
STATES

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

KRKA Sverige AB
Göta Ark 175, Medborgarplatsen 25
S-118 72 Stockholm

Denmark

Finland

Norway

Sweden

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

Simvastatin Krka

80 mg

Film-coated tablets

Oral use

KRKA Sverige AB
Göta Ark 175, Medborgarplatsen 25
S-118 72 Stockholm

KRKA Sverige AB
Göta Ark 175, Medborgarplatsen 25
S-118 72 Stockholm

KRKA Sverige AB
Göta Ark 175, Medborgarplatsen 25
S-118 72 Stockholm

.

.

2
8
3
2
0
0
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

C

7
7
/
1
7