# C_2008132EN.01001101.xml

| 30.5.2008 | EN | Official Journal of the European Union | C 132/11 |
| --- | --- | --- | --- |

30.5.2008

EN

Official Journal of the European Union

C 132/11

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2008 to 30 April 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)
  )

(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 132/04)

—   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 |
| --- | --- | --- | --- | --- |
| 1.4.2008 | Menitorix | See Annex I | See Annex I | 2.4.2008 |
| 2.4.2008 | Compagel gel for horses | See Annex II | See Annex II | 3.4.2008 |
| 16.4.2008 | Thalidomide Pharmion | Pharmion Ltd, Riverside House |
| Riverside Walk |
| Windsor SL4 1NA |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

1.4.2008

Menitorix

See Annex I

See Annex I

2.4.2008

2.4.2008

Compagel gel for horses

See Annex II

See Annex II

3.4.2008

16.4.2008

Thalidomide Pharmion

Pharmion Ltd, Riverside House

Riverside Walk

Windsor SL4 1NA

United Kingdom

This Decision is addressed to the Member States

17.4.2008

17.4.2008

Solacyl 100 % powder for oral solution

See Annex III

See Annex III

18.4.2008

21.4.2008

Volibris

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

This Decision is addressed to the Member States

22.4.2008

25.4.2008

Mycamine

| Astellas Pharma GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

This Decision is addressed to the Member States

28.4.2008

25.4.2008

NovoSeven

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

This Decision is addressed to the Member States

28.4.2008

—   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 |
| --- | --- | --- | --- | --- |
| 17.4.2008 | Eformax | See Annex IV | See Annex IV | 18.4.2008 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

17.4.2008

Eformax

See Annex IV

See Annex IV

18.4.2008

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

1

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

2

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ANNEX I

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

| Member State | Marketing Authorisation Holder | Applicant | Invented Name | Strength (1) | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| United Kingdom | SmithKline Beecham PLC |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| United Kingdom |

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength (1)

Pharmaceutical form

Route of administration

Content

(concentration)

United Kingdom

SmithKline Beecham PLC

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Menitorix

5 μg Hib PRP + 12,5 μg TT + 5 μg MenC PSC + 5 μg TT

Powder and solvent for solution for injection

Intramuscular injection

0,5 ml

Belgium

| GlaxoSmithkline Biologicals S.A. |
| --- |
| 89, rue de l'Institut |
| B-1330 Rixensart |

GlaxoSmithkline Biologicals S.A.

89, rue de l'Institut

B-1330 Rixensart

Menitorix

5 μg Hib PRP + 12,5 μg TT + 5 μg MenC PSC + 5 μg TT

Powder and solvent for solution for injection

Intramuscular injection

0,5 ml

Greece

| GlaxoSmithkline Α.Ε.Β.Ε. |
| --- |
| 266 Leof. Kifisias |
| GR-152 32 Halandri |

GlaxoSmithkline Α.Ε.Β.Ε.

266 Leof. Kifisias

GR-152 32 Halandri

Menitorix

5 μg Hib PRP + 12,5 μg TT + 5 μg MenC PSC + 5 μg TT

Powder and solvent for solution for injection

Intramuscular injection

0,5 ml

Ireland

| GlaxoSmithKline (Ireland) Ltd |
| --- |
| Stonemasons Way |
| Rathfarnham |
| Dublin 16 |
| Ireland |

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Menitorix

5 μg Hib PRP + 12,5 μg TT + 5 μg MenC PSC + 5 μg TT

Powder and solvent for solution for injection

Intramuscular injection

0,5 ml

Poland

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| United Kingdom |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Menitorix

5 μg Hib PRP + 12,5 μg TT + 5 μg MenC PSC + 5 μg TT

Powder and solvent for solution for injection

Intramuscular injection

0,5 ml

Spain

| GlaxoSmithKline S.A. |
| --- |
| Severo Ochoa no 2 |
| Tres Cantos |
| E-28760 Madrid |

GlaxoSmithKline S.A.

Severo Ochoa no 2

Tres Cantos

E-28760 Madrid

Menitorix

5 μg Hib PRP + 12,5 μg TT + 5 μg MenC PSC + 5 μg TT

Powder and solvent for solution for injection

Intramuscular injection

0,5 ml

---

(1)

Hib PRP— Haemophilus influenzae type B polyribosylribitol phosphate

TT— Tetanus toxoid

MenC PSC— Neisseria meningitidis serogroup C polysaccharide.

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ANNEX II

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

| Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- |
| Boehringer Ingelheim Vetmedica GmbH |
| Binger Str. 173 |
| D-55216 Ingelheim |

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

D-55216 Ingelheim

Compagel gel for horses

Gel

100 g gel contains:

| | heparin sodium 50 000 IU |
| --- | --- |

heparin sodium 50 000 IU

| | levomenthol 0,5 g |
| --- | --- |

levomenthol 0,5 g

| | hydroxyethyl salicylate 5,0 g |
| --- | --- |

hydroxyethyl salicylate 5,0 g

Horse

Topical

Up to a total daily quantity of 50 g gel per day is applied using finger tip pressure onto the affected area according to the veterinary surgeon's instructions until signs and symptoms resolve.

After nerve block anaesthesia the gel should be applied to the skin in a layer the thickness of the back of a knife and covered with a bandage

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ANNEX III

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

| Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- |
| Eurovet animal Health B.V. | Solacyl 100 % powder for oral solution | Powder | 100 % | Calves and pigs | Oral | Calves: 20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.
  Administration: orally in drinking water or milk (replacer).
  Pigs: 35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.
  Administration: orally in drinking water.
  Alternatively, Solacyl can also be administered with the drinking water as pulse medication. Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed. This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily |

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Eurovet animal Health B.V.

Solacyl 100 % powder for oral solution

Powder

100 %

Calves and pigs

Oral

Calves: 20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.

Administration: orally in drinking water or milk (replacer).

Pigs: 35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.

Administration: orally in drinking water.

Alternatively, Solacyl can also be administered with the drinking water as pulse medication. Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed. This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily

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ANNEX IV

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

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Denmark | Norton Healthcare Ltd |
| (trading as IVAX Pharmaceuticals UK) |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Denmark

Norton Healthcare Ltd

(trading as IVAX Pharmaceuticals UK)

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Eformax 6 μg

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 μg

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Cyprus

| Norton Healthcare Ltd |
| --- |
| (trading as IVAX Pharmaceuticals UK) |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

Norton Healthcare Ltd

(trading as IVAX Pharmaceuticals UK)

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Eformax 6 mcg

Σκόνη για εισπνοή

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 mcg

Σκόνη για εισπνοή

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Czech Republic

| Teva Pharmaceuticals ČR, s.r.o |
| --- |
| Radlická 3185/1c |
| CZ-150 00 Praha 5 |

Teva Pharmaceuticals ČR, s.r.o

Radlická 3185/1c

CZ-150 00 Praha 5

Eformax 6 μg

Prášek k inhalaci

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 μg

Prášek k inhalaci

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Estonia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR, Utrecht |
| Nederland |

Teva Pharma B.V.

Computerweg 10

3542 DR, Utrecht

Nederland

Eformax

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Germany

| Norton Healthcare Ltd |
| --- |
| (trading as IVAX Pharmaceuticals UK) |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

Norton Healthcare Ltd

(trading as IVAX Pharmaceuticals UK)

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Eformax 6 Mikrogramm

Pulver zur Inhalation

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 Mikrogramm

Pulver zur Inhalation

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Latvia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR, Utrecht |
| Nederland |

Teva Pharma B.V.

Computerweg 10

3542 DR, Utrecht

Nederland

Eformax

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Lithuania

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR, Utrecht |
| Nederland |

Teva Pharma B.V.

Computerweg 10

3542 DR, Utrecht

Nederland

Eformax 6 mikrogramų/dozėje inhaliaciniai milteliai

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 mikrogramų

dozėje inhaliaciniai milteliai

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Malta

| Norton Healthcare Ltd |
| --- |
| (trading as IVAX Pharmaceuticals UK) |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

Norton Healthcare Ltd

(trading as IVAX Pharmaceuticals UK)

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Eformax 6 μg

Trab li jittieħed bin-nifs

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 μg

Trab li jittieħed bin-nifs

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Poland

| Norton Healthcare Ltd |
| --- |
| (trading as IVAX Pharmaceuticals UK) |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

Norton Healthcare Ltd

(trading as IVAX Pharmaceuticals UK)

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Eformax 6 mcg

proszek do inhalacji

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 mcg

proszek do inhalacji

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Portugal

| Teva Pharma — Produtos Farmacêuticos, Lda. |
| --- |
| Lagoas Park |
| Edifício 1 |
| Piso 3 |
| P-2740-264 Porto Salvo |

Teva Pharma — Produtos Farmacêuticos, Lda.

Lagoas Park

Edifício 1

Piso 3

P-2740-264 Porto Salvo

Eformax

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Slovakia

| Norton Healthcare Ltd |
| --- |
| (trading as IVAX Pharmaceuticals UK) |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

Norton Healthcare Ltd

(trading as IVAX Pharmaceuticals UK)

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Eformax 6

Inhalačný prášok

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 μg

Inhalačný prášok

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Sweden

| Teva Sweden AB |
| --- |
| P.O. Box 1070 |
| S-25 110 Helsingborg |

Teva Sweden AB

P.O. Box 1070

S-25 110 Helsingborg

Eformax 6 μg

inhalationspulver

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 μg

inhalationspulver

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

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