# C_2007174EN.01001001.xml

| 27.7.2007 | EN | Official Journal of the European Union | C 174/10 |
| --- | --- | --- | --- |

27.7.2007

EN

Official Journal of the European Union

C 174/10

---

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)
  )

(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 | Date of notification |
| --- | --- | --- | --- | --- |
| 7.6.2007 | Tracleer | Actelion Registration Ltd |
| BSI Building 13th Floor |
| 389 Chiswick High Road |
| London W4 4AL |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

7.6.2007

Tracleer

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

This Decision is addressed to the Member States

8.6.2007

14.6.2007

Revlimid

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

Celgene Europe Limited

8 The Square

Stockley Park

Uxbridge

Middlesex UB11 1FW

United Kingdom

This Decision is addressed to the Member States

18.6.2007

14.6.2007

Mifegyne

See Annex I

See Annex I

18.6.2007

20.6.2007

Soliris

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

Alexion Europe SAS

54-56, Avenue Hoche

F-75008 Paris

This Decision is addressed to the Member States

21.6.2007

29.6.2007

Bovilis BVD

See Annex II

See Annex II

2.7.2007

29.6.2007

Siklos

| Addmedica |
| --- |
| 84, rue d'Amsterdam |
| F-75009 Paris |

Addmedica

84, rue d'Amsterdam

F-75009 Paris

This Decision is addressed to the Member States

3.7.2007

—   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 | Date of notification |
| --- | --- | --- | --- | --- |
| 13.6.2007 | Suramox 15 % LA et Stabox 15 % LA | See Annex III | See Annex III | 14.6.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

13.6.2007

Suramox 15 % LA et Stabox 15 % LA

See Annex III

See Annex III

14.6.2007

---

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

1

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

2

---

ANNEX I

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH 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 |
| --- | --- | --- | --- | --- | --- |
| Austria | Exelgyn |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Belgium

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Denmark

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Estonia

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Finland

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

France

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Germany

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

Contragest GmbH

Pharmavertrieb

Kelsterbacher Str. 28

D-64546 Walldorf-Mörfelden

Mifegyne

200 mg

Tablet

Oral use

Greece

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Latvia

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Luxembourg

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Norway

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Spain

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

Sweden

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

The Netherlands

| Bipharma B.V. |
| --- |
| Postbus 151 |
| 1380 AD Weesp |
| Nederland |

Bipharma B.V.

Postbus 151

1380 AD Weesp

Nederland

Mifegyne

200 mg

Tablet

Oral use

UK

| Exelgyn |
| --- |
| 216, Boulevard St Germain |
| F-75 007 Paris |

Exelgyn

216, Boulevard St Germain

F-75 007 Paris

Mifegyne

200 mg

Tablet

Oral use

---

ANNEX II

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

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet Deutschland GmbH |
| Feldstrasse 1a |
| D-85716 Unterschleissheim |
| Tel. (49-89) 310 062 59 |
| Fax (49-89) 310 03 27 |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Austria

Intervet Deutschland GmbH

Feldstrasse 1a

D-85716 Unterschleissheim

Tel. (49-89) 310 062 59

Fax (49-89) 310 03 27

Bovilis BVD-MD

Suspension for injection

Per 2 ml dose:

50 ELISA units, inducing ≥ 4,6 log2 VN units

Cattle

Intramuscular injection

(Immunisation schedules are given in the product information.)

One dose = 2 ml

Belgium

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

Intervet Belgium

Bedrijvenlaan 7

B-2800 Mechelen

Tel. (32-15) 43 67 28

Fax (32-15) 43 67 33

Bovilis BVD

As above

As above

As above

As above

As above

Bulgaria

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

Intervet Bulgaria EOOD

7, Iskarsko shose blvd

BG-1528 Sofia

Tel. (359-2) 970 10 70

Fax (359-2) 971 09 00

Bovilis BVD

As above

As above

As above

As above

As above

Cyprus

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

Medivet Suppliers Ltd

87c Aglandjias Avenue

PO Box 20932

CY-1665 Nicosia

Tel. (357) 22 33 66 05

Fax (357) 22 33 66 07

Bovilis BVD

As above

As above

As above

As above

As above

Czech Republic

| 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 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

Bovilis BVD

As above

As above

As above

As above

As above

Denmark

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

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

As above

As above

As above

As above

As above

Estonia

| 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

Bovilis BVD

As above

As above

As above

As above

As above

France

| 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 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

Bovilis BVD

As above

As above

As above

As above

As above

Germany

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

Intervet Deutschland GmbH

Feldstrasse 1a

D-85716 Unterschleissheim

Tel. (49-89) 310 062 59

Fax (49-89) 310 03 27

Bovilis BVD-MD

As above

As above

As above

As above

As above

Greece

| 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 Hellas S.A.

3, Paparigopoulou Street

GR-152 32 Halandri Athens

Tel. (30-210) 689 04 11

Fax (30-210) 683 25 23

Bovilis BVD

As above

As above

As above

As above

As above

Hungary

| 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 Hungaria Kft.

Boráros tér. 7/2. 7.e.13

H-1095 Budapest

Tel. (36-1) 456 30 90

Fax (36-1) 456 30 99

Bovilis BVD

As above

As above

As above

As above

As above

Ireland

| 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 |

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

Italy

| 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 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

Bovilis BVD

As above

As above

As above

As above

As above

Latvia

| 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

Bovilis BVD

As above

As above

As above

As above

As above

Lithuania

| 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

Bovilis BVD

As above

As above

As above

As above

As above

Luxembourg

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

Intervet Belgium

Bedrijvenlaan 7

B-2800 Mechelen

Tel. (32-15) 43 67 28

Fax (32-15) 43 67 33

Bovilis BVD

As above

As above

As above

As above

As above

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 |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Tel. (31-485) 58 76 52

Fax (31-485) 58 76 53

Bovilis BVD

As above

As above

As above

As above

As above

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 |

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

Portugal

| 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 |

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

Bovilis BVD

As above

As above

As above

As above

As above

Slovakia

| 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 |

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

Bovilis BVD

As above

As above

As above

As above

As above

Slovenia

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

Intervet International Podružnica

Križna 10

SLO-1000 Ljubljana

Tel. (386-1) 541 75 67

Fax (386-1) 523 35 67

Bovilis BVD

As above

As above

As above

As above

As above

Spain

| 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 |

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

Bovilis BVD

As above

As above

As above

As above

As above

UK

| 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 |

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

---

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

| Member State | Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose | Withdrawal period
  (meat and milk) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | Virbac S.A. |
| 1e Avenue |
| 2056 M Lid |
| F-06516 Carros Cedex |

Member State

Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period

(meat and milk)

Czech Republic

Virbac S.A.

1e Avenue

2056 M Lid

F-06516 Carros Cedex

Suramox 15 % LA

Suspension for injection

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 |
| --- | --- |

Cattle: 58 days

| | Pigs: 35 days |
| --- | --- |

Pigs: 35 days

| | Milk: 2,5 days |
| --- | --- |

Milk: 2,5 days

Spain (1)

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

Virbac S.A.

1e Avenue

2056 M Lid

F-06516 Carros Cedex

Stabox 15 % LA

Suspension for injection

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 |
| --- | --- |

Cattle: 58 days

| | Pigs: 35 days |
| --- | --- |

Pigs: 35 days

| | Milk: 2,5 days |
| --- | --- |

Milk: 2,5 days

Italy

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

Virbac S.A.

1e Avenue

2056 M Lid

F-06516 Carros Cedex

Stabox 15 % LA

Suspension for injection

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 |
| --- | --- |

Cattle: 58 days

| | Pigs: 35 days |
| --- | --- |

Pigs: 35 days

| | Milk: 2,5 days |
| --- | --- |

Milk: 2,5 days

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

Suramox 15 % LA

Suspension for injection

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 |
| --- | --- |

Cattle: 58 days

| | Pigs: 35 days |
| --- | --- |

Pigs: 35 days

| | Milk: 2,5 days |
| --- | --- |

Milk: 2,5 days

---

(1)  Marketing Authorisation pending.

(2)  Reference Member State for the Mutual recognition Procedure.

---