Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2007 to 30 November 2007 (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: 2007-12-28
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

C 316/48

EN

Official Journal of the European Union

28.12.2007

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 November 2007 to 30 November 2007

(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))

(2007/C 316/06)

— Issuing, maintenance or modification of a national marketing authorization

Date of the
decision

Name(s) of the
medicinal
product

19.11.2007

Tasigna

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

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

This Decision is addressed to
the Member States

20.11.2007

22.11.2007

Bicaluplex

See Annex I

See Annex I

23.11.2007

(Decisions taken pursuant to Article 107 of Directive 2001/83/EC)

— 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

30.11.2007

Clobutinol

See Annex II

See Annex II

Date of
notification

3.12.2007

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

ANNEX I

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

.

2
8
1
2
2
0
0
7

.

Member State

Marketing authorisation holder

Applicant

Name

Strength

Pharmaceutical form

Route of administration

Austria

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

Bicalutamid-TEVA 150 mg-Filmtable-
tten

150 mg

Film-coated tablet

Oral use

Czech Republic

Ingers Industrial Solutions s. r. o.
Jeneweinova 51a
CZ-617 00 Brno

Bicaluplex 150 mg

150 mg

Film-coated tablet

Oral use

Germany

Denmark

Estonia

Greece

France

Ingers Industrial Solutions s. r. o.
Jeneweinova 51a
CZ-617 00 Brno

Bicamid-GRY 150 mg Filmtabletten

150 mg

Film-coated tablet

Oral use

TEVA Sweden AB
PO Box 1070
S-25110 Helsingborg

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

TEVA Classics S.A.
1, cours du Triangle
Immeuble Palatin 1
F-92936 Paris La Défense
Cedex 12

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

Bicalutamid TEVA

150 mg

Film-coated tablet

Oral use

Bicalutamide-TEVA

150 mg

Film-coated tablet

Oral use

Bicalutamide
Teva
comprimés pelliculés

150

mg,

150 mg

Film-coated tablet

Oral use

Bicalutamide Teva 150 mg

150 mg

Film-coated tablet

Oral use

Επικαλυµµένα µε λεπτό υµένιο δισκία

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

3
1
6
/
4
9

Member State

Marketing authorisation holder

Applicant

Name

Strength

Pharmaceutical form

Route of administration

Hungary

Italy

Latvia

Lithuania

The Netherlands

Norway

Poland

Portugal

Slovakia

TEVA Magyarország Rt
Rákóczi út 70-72
H-1074 Budapest

TEVA Pharma Italia S.R.L.
Viale G. Richard 7
I-20143 Milano

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

Pharmachemie B.V.
Swensweg 5
Postbus 552
2003 RN Haarlem
Nederland

TEVA Sweden AB
PO Box 1070
S-25110 Helsingborg

Bicalutamid-Teva

150 mg

Film-coated tablet

Oral use

Bicalutamide
compresse rivestite con film

TEVA

150

mg

150 mg

Film-coated tablet

Oral use

Bicalutamide-TEVA

150 mg

Film-coated tablet

Oral use

Bicalutamide-Teva 150 mg plėvele
dengtos tabletės

150 mg

Film-coated tablet

Oral use

Bicalutamide 150 PCH, filmomhulde
tabletten 150 mg

150 mg

Film-coated tablet

Oral use

Bicalutamid TEVA 150 mg tabletter,
filmdrasjerte

150 mg

Film-coated tablet

Oral use

Ingers Industrial Solutions s. r. o.
Jeneweinova 51a
CZ-617 00 Brno

Bicalutamide Ingers 150 mg tabletki
powlekane

150 mg

Film-coated tablet

Oral use

TEVA Pharma — Produtos Farma-
cêuticos Lda
Lagoas Park
Edifício 1
Piso 3
P-2740-264 Porto Salvo

Ingers Industrial Solutions s. r. o.
Jeneweinova 51a
CZ-617 00 Brno

Bicalutamida Teva

150 mg

Film-coated tablet

Oral use

Bicalutamid-Teva 150 mg

150 mg

Film-coated tablet

Oral use

C

3
1
6
/
5
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
1
2
2
0
0
7

.

Member State

Marketing authorisation holder

Applicant

Name

Strength

Pharmaceutical form

Route of administration

Slovenia

Sweden

The United Kingdom

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

Ingers Industrial Solutions s. r. o.
Jeneweinova 51a
CZ-617 00 Brno

Ingers Industrial Solutions s. r. o.
Jeneweinova 51a
CZ-617 00 Brno

Bikalutamid TEVA 150 mg filmsko
obložene tablete

150 mg

Film-coated tablet

Oral use

Bicalutamide Teva 150 mg filmdra-
gerade tabletter

150 mg

Film-coated tablet

Oral use

Bicalutamide 150 mg Film-coated
Tablets

150 mg

Film-coated tablet

Oral use

.

2
8
1
2
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

3
1
6
/
5
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

Member State

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Clobutinol containing medicinal products with marketing authorisation in the European Union

Austria

Austria

Austria

Belgium

Belgium

Belgium

Czech Republic

Czech Republic

Czech Republic

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5-11
A-1121 Wien

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5-11
A-1121 Wien

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5-11
A-1121 Wien

SCS Boehringer Ingelheim Comm.V.
Avenue Ariane 16
B-1200 Bruxelles

SCS Boehringer Ingelheim Comm.V.
Avenue Ariane 16
B-1200 Bruxelles

SCS Boehringer Ingelheim Comm.V.
Avenue Ariane 16
B-1200 Bruxelles

Boehringer Ingelheim GmbH
Binger Str. 173
D-55216 Ingelheim am Rhein

Boehringer Ingelheim GmbH
Binger Str. 173
D-55216 Ingelheim am Rhein

Boehringer Ingelheim GmbH
Binger Str. 173
D-55216 Ingelheim am Rhein

Silomat — Dragees

40 mg

Coated tablet

Oral use

Silomat — Hustensaft

40 mg/10 ml

Oral solution

Oral use

Silomat — Tropfen

60 mg/ml

Oral drops, solution

Oral use

Silomat

Silomat

Silomat

Silomat

Silomat

Silomat

40 mg

Tablets

Oral use

60mg

Oral solution

Oral use

20 mg/5 ml

Syrup

Oral use

20 mg/2 ml

Solution for injection

Intramuscular or intravenous use

40 mg/10 ml

Syrup

Oral use

900 mg/5 ml

Oral drops, solution

Oral use

C

3
1
6
/
5
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
1
2
2
0
0
7

.

Member State

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Boehringer Ingelheim Pharma GmbH & Co.KG
Binger Str. 173
D-55216 Ingelheim

Boehringer Ingelheim Pharma GmbH & Co.KG
Binger Str. 173
D-55216 Ingelheim

Boehringer Ingelheim Pharma GmbH & Co.KG
Binger Str. 173
D-55216 Ingelheim

Boehringer Ingelheim Pharma GmbH & Co.KG
Binger Str. 173
D-55216 Ingelheim

Boehringer Ingelheim Pharma GmbH & Co.KG
Binger Str. 173
D-55216 Ingelheim

Boehringer Ingelheim Pharma GmbH & Co.KG
Binger Str. 173
D-55216 Ingelheim

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Clobutinol Kapseln 80 mg

80 mg

Capsule, hard

Oral use

Clobutinol -Tropfen TH

40 mg/0,67 ml

Oral drops, solution

Oral use

Silomat Ampullen gegen Reizhusten

20 mg/2 ml

Solution for injection

Intramuscular or intravenous use

Silomat Dragees gegen Reizhusten

40 mg

Coated tablet

Oral use

Silomat Saft gegen Reizhusten

40 mg/10 ml

Solution

Oral use

Silomat Tropfen gegen Reithusten

40 mg/0,67 ml

Oral drops, solution

Oral use

Clobutinol-Chephasaar Kapsel 40 mg

40 mg

Capsule, hard

Oral use

Clobutinol-Chephasaar Saft 4mg/ml

4 mg/1 ml

Oral solution

Oral use

Clobutinol-MIP Kapsel 40 mg

40 mg

Capsule, hard

Oral use

Clobutinol-MIP Tropfen 80 mg/ml

80 mg/1 ml

Oral solution

Oral use

.

2
8
1
2
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

3
1
6
/
5
3

Member State

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische Fabrik
GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

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

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

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

Rofatuss forte

80 mg

Capsule, hard

Oral use

Rofatuss N

40 mg

Capsule, hard

Oral use

Rofatuss Saft

400 mg/100 ml

Oral solution

Oral use

Rofatuss Tropfen

80 mg/1 ml

Oral drops, solution

Oral use

Silomat Dragees gegen Reizhusten

40 mg

Coated tablet

Oral use

Silomat Saft

40 mg/10 ml

Oral solution

Oral use

Clobutinol Tropfen

40 mg/0,67 ml

Oral drops, solution

Oral use

Tussed Hustenstiller Dragees

40 mg

Coated tablet

Oral use

Tussed Hustenstiller Saft

40 mg/10 ml

Oral solution

Oral use

Tussed Hustenstiller Tropfen

40 mg/0,67 ml

Solution

Oral use

C

3
1
6
/
5
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
1
2
2
0
0
7

.

Member State

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Greece

Greece

Greece

Finland

Hofmann & Sommer GmbH & Co.KG
Chemisch-pharmazeutische Fabrik
Lindenstr. 11
D-07426 Königsee

kohlpharma GmbH
Im Holzhau 8
D-66663 Merzig

Pharma Westen GmbH
Fixheider Str. 4
D-51381 Leverkusen

Pharma Westen GmbH
Fixheider Str. 4
D-51381 Leverkusen

ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

Boehringer Ingelheim Hellas S.A.
2 Ellinikou str.
GR-167 77 Athens

Boehringer Ingelheim Hellas S.A.
2 Ellinikou str.
GR-167 77 Athens

Boehringer Ingelheim Hellas S.A.
2 Ellinikou str.
GR-167 77 Athens

Boehringer Ingelheim Finland Ky
Tammasaarenkatu 5
FI-00180 Helsinki

Nullatuss Clobutinol Hustentropfen

6 g/100 g

Oral drops, solution

Oral use

Silomat Tropfen gegen Reithusten

40 mg/0,67 ml

Oral solution

Oral use

Silomat Dragees gegen Reizhusten

40 mg

Coated tablet

Oral use

Silomat Saft gegen Reizhusten

40 mg/10 ml

Oral solution

Oral use

Hustenstiller-ratiopharm Clobutinol

20 mg/5 ml

Oral solution

Oral use

Hustenstiller-ratiopharm Clobutinol
Kapseln

80 mg

Capsule, hard

Oral use

Hustenstiller-ratiopharm Clobutinol
Tropfen

80 mg/1 ml

Oral solution

Oral use

Silomat Compositum

20+5 mg/5ml

Syrup

Oral use

(Clobutinol HCl + Orciprenaline
Sulfate)

Silomat

Silomat

Silomat

60 mg/ml

Oral Solution, Drops

Oral use

20 mg/5ml

Syrup

Oral use

4 mg/ml

Oral solution

Oral use

.

2
8
1
2
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

3
1
6
/
5
5

Member State

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Finland

Finland

France

France

France

France

Boehringer Ingelheim Finland Ky
Tammasaarenkatu 5
FI-00180 Helsinki

Orion Corporation, ORION PHARMA
Tengströminkatu 8
P.O.Box 425
FI-20101 Turku

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

Silomat

Mixtus

Silomat

Silomat

Silomat

Silomat

40 mg

Coated tablet

Oral use

4 mg/ml

Oral solution

Oral use

0,40 %

Syrup

Oral use

20 mg/2 ml

Solution for injection

Intramuscular or intravenous use

40 mg

Coated tablet

Oral use

6 %

Oral drops, solution

Oral use

C

3
1
6
/
5
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
1
2
2
0
0
7

.