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) )

(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 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 This Decision is addressed to the Member States 22.4.2008 25.4.2008 Mycamine 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 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

(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 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 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 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 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 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 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 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.

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 Compagel gel for horses Gel 100 g gel contains: heparin sodium 50 000 IU levomenthol 0,5 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

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