Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2007 to 30 June 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: 2007-07-27
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, veterinary drug, withdrawal from the market

C 174/10

EN

Official Journal of the European Union

27.7.2007

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 June 2007 to 30 June 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 174/05)

— 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

7.6.2007

Tracleer

14.6.2007

Revlimid

Actelion Registration Ltd
BSI Building 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom

Celgene Europe Limited
8 The Square
Stockley Park
Uxbridge
Middlesex UB11 1FW
United Kingdom

This Decision is addressed to
the Member States

Date of
notification

8.6.2007

This Decision is addressed to
the Member States

18.6.2007

14.6.2007 Mifegyne

See Annex I

See Annex I

20.6.2007

Soliris

Alexion Europe SAS
54-56, Avenue Hoche
F-75008 Paris

This Decision is addressed to
the Member States

29.6.2007

Bovilis BVD

See Annex II

See Annex II

29.6.2007

Siklos

Addmedica
84, rue d'Amsterdam
F-75009 Paris

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

13.6.2007

Suramox 15 % LA et
Stabox 15 % LA

See Annex III

See Annex III

18.6.2007

21.6.2007

2.7.2007

3.7.2007

Date of
notification

14.6.2007

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

27.7.2007

EN

Official Journal of the European Union

C 174/11

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

ANNEX I

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of
administration

Austria

Belgium

Denmark

Estonia

Finland

France

Germany

Greece

Latvia

Luxembourg

Norway

Spain

Sweden

The Netherlands

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Contragest GmbH
Pharmavertrieb
Kelsterbacher Str. 28
D-64546 Walldorf-Mörfelden

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Bipharma B.V.
Postbus 151
1380 AD Weesp
Nederland

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

Mifegyne

200 mg

Tablet

Oral use

UK

Exelgyn
216, Boulevard St Germain
F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

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

ANNEX II

Member State

Applicant or Marketing Authorisation
Holder

Product invented
name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Intervet Deutschland GmbH
Feldstrasse 1a
D-85716 Unterschleissheim
Tel. (49-89) 310 062 59
Fax (49-89) 310 03 27

Intervet Belgium
Bedrijvenlaan 7
B-2800 Mechelen
Tel. (32-15) 43 67 28
Fax (32-15) 43 67 33

Intervet Bulgaria EOOD
7, Iskarsko shose blvd
BG-1528 Sofia
Tel. (359-2) 970 10 70
Fax (359-2) 971 09 00

Medivet Suppliers Ltd
87c Aglandjias Avenue
PO Box 20932
CY-1665 Nicosia
Tel. (357) 22 33 66 05
Fax (357) 22 33 66 07

Intervet s.r.o.
Zlicin Business Centre
Na Radosti 413
CZ-155 21 Prague 5
Tel. (420-2) 33 34 40 25
Fax (420-2) 33 34 40 22

Intervet Danmark AS
PO Box 66
Literbuen 9
DK-2740 Skovlunde
Tel. (45-44) 54 69 00
Fax (45-44) 53 19 55

Bovilis BVD-MD

Suspension for injection

Per 2 ml dose:

Cattle

Intramuscular injection

One dose = 2 ml

50 ELISA units,
≥ 4,6 log2 VN units

inducing

(Immunisation schedules are
given in the product informa-
tion.)

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

C

1
7
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
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r
o
p
e
a
n
U
n
o
n

i

.

.

2
7
7
2
0
0
7

Member State

Applicant or Marketing Authorisation
Holder

Product invented
name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Estonia

France

Germany

Greece

Hungary

Ireland

Intervet Baltic States
Vasario 16-osios 9-6A
LT-Kaunas 3000
Tel. (370) 37 32 16 60
Fax (370) 37 20 12 93

Intervet S.A.
Rue Olivier de Serres
Angers Technopole
BP 17144
F-49071 Beaucouzé Cedex
Tel. (33-2) 41 22 83 83
Fax (33-2) 41 22 83 00

Intervet Deutschland GmbH
Feldstrasse 1a
D-85716 Unterschleissheim
Tel. (49-89) 310 062 59
Fax (49-89) 310 03 27

Intervet Hellas S.A.
3, Paparigopoulou Street
GR-152 32 Halandri Athens
Tel. (30-210) 689 04 11
Fax (30-210) 683 25 23

Intervet Hungaria Kft.
Boráros tér. 7/2. 7.e.13
H-1095 Budapest
Tel. (36-1) 456 30 90
Fax (36-1) 456 30 99

Intervet Ireland Ltd
Magna Drive
Magna Business Park
Citywest Road
Dublin 24
Ireland
Tel. (353-1) 463 73 30
Fax (353-1) 451 19 06

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD-MD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

.

.

2
7
7
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
7
4
/
1
3

Member State

Applicant or Marketing Authorisation
Holder

Product invented
name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Italy

Latvia

Lithuania

Luxembourg

Intervet Italia S.r.l.
Via W. Tobagi 7
I-20068 Peschiera Borromeo —
Milano
Tel. (39) 02 51 68 61
Fax (39) 02 51 68 66 87

Intervet Baltic States
Vasario 16-osios 9-6A
LT-Kaunas 3000
Tel. (370) 37 32 16 60
Fax (370) 37 20 12 93

Intervet Baltic States
Vasario 16-osios 9-6A
LT-Kaunas 3000
Tel. (370) 37 32 16 60
Fax (370) 37 20 12 93

Intervet Belgium
Bedrijvenlaan 7
B-2800 Mechelen
Tel. (32-15) 43 67 28
Fax (32-15) 43 67 33

The Netherlands

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland
Tel. (31-485) 58 76 52
Fax (31-485) 58 76 53

Poland

Intervet International BV Sp. z o.o.
Przedstawicielstwo w Polsce
ul. Wybrzeże Gdyńskie 6c
PL-01-531 Warszawa
Tel. (48-22) 620 11 47
Fax (48-22) 620 29 35

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

C

1
7
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
7
7
2
0
0
7

Member State

Applicant or Marketing Authorisation
Holder

Product invented
name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Portugal

Slovakia

Slovenia

Spain

UK

Intervet Portuguesa Ltd
Estrada Nacional 249, Km 14,2
P-2725-397 Mem Martins Codes
Tel. (351-21) 922 83 00
Fax (351-21) 920 22 31

Representative of Intervet in the
Slovak Rep.
Palárikova 16
SK-040 01 Košice
Tel. (421-55) 676 94 05
Fax (421-55) 676 98 73

Intervet International Podružnica
Križna 10
SLO-1000 Ljubljana
Tel. (386-1) 541 75 67
Fax (386-1) 523 35 67

Laboratorios Intervet, S.A.
Polígono Industrial «El Montalva»
Apartado 3006
E-37080 Salamanca
Tel. (34-923) 19 03 45
Fax: (34-923) 19 03 47

Intervet UK Ltd
Walton Manor
Walton
Milton Keynes
Buckinghamshire MK7 7AJ
United Kingdom
Tel. (44-1908) 66 50 50
Fax (44-1908) 66 47 78

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

Bovilis BVD

As above

As above

As above

As above

As above

.

.

2
7
7
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
7
4
/
1
5

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND
ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING
AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL

C

1
7
4
/
1
6

Member State

Marketing
Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Withdrawal period
(meat and milk)

E
N

Czech Republic

Spain (1)

Italy

France (2)

Virbac S.A.
1e Avenue
2056 M Lid
F-06516 Carros
Cedex

Virbac S.A.
1e Avenue
2056 M Lid
F-06516 Carros
Cedex

Virbac S.A.
1e Avenue
2056 M Lid
F-06516 Carros
Cedex

Virbac S.A.
1e Avenue
2056 M Lid
F-06516 Carros
Cedex

Suramox 15 % LA

Suspension for injec-
tion

150 mg/ml

Cattle, pigs

Two intramuscular injections
at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Stabox 15 % LA

Suspension for injec-
tion

150 mg/ml

Cattle, pigs

Two intramuscular injections
at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Stabox 15 % LA

Suspension for injec-
tion

150 mg/ml

Cattle, pigs

Two intramuscular injections
at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Suramox 15 % LA

Suspension for injec-
tion

150 mg/ml

Cattle, pigs

Two intramuscular injections
at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

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

(1) Marketing Authorisation pending.
(2) Reference Member State for the Mutual recognition Procedure.

.

.

2
7
7
2
0
0
7