EN Official Journal of the European Union C 111/16

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010

(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) )

2010/C 111/03

— Issuing, maintenance or modification 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 20.1.2010 Extraneal See Annex I See Annex I 22.1.2010 26.1.2010 Antiadiposo — iodocasein/thiamine nitrate See Annex II See Annex II 27.1.2010 25.1.2010 Poulvac Bursa Plus and associated names See Annex III See Annex III 26.1.2010 8.1.2010 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM This Decision is addressed to the Member States 11.1.2010 29.1.2010 Urorec Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork IRELAND This Decision is addressed to the Member States 1.2.2010 29.1.2010 Silodyx Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork IRELAND This Decision is addressed to the Member States 1.2.2010





— Refusal 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 29.1.2010 Teicoplanin Hospira and associated names See Annex IV See Annex IV 2.2.2010





— 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 27.1.2010 APPM Respipharm See Annex V See Annex V 28.1.2010

(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 PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing autorisation Holder Invented Name Strength Pharmaceutical form Route of administration Austria Baxter Vertriebs GmbH Landstraßer Hauptstraße 99/Top2A 1031 Wien ÖSTERREICH Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Belgium Baxter S.A. Boulevard R. Branquart 80 7680 Lessines BELGIQUE/BELGIË Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Denmark Baxter A/S Gydevang 43 3450 Allerød DANMARK Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Finland Baxter Oy P.O. Box 270 Valimotie 15A FI-00381 Helsinski SUOMI/FINLAND Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use France Baxter S.A.S 6 av. Louis Pasteur 78310 Maurepas FRANCE Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Germany Baxter Deutschland GmbH Edissontrasse 3—4 85716 Unterschleissheim DEUTSCHLAND Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Greece Diophar A.E. Kiphissias 368 152 33 Halandri Athens GREECE Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Ireland Baxter Healthcare Ltd Caxton Way Thetford IP24 3SE UNITED KINGDOM Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Italy Baxter S.p.A. Piazzale dell’Industria 20 00144 Roma RM ITALIA Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Luxembourg Baxter S.A. Boulevard R. Branquart 80 7680 Lessines BELGIQUE/BELGIË Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Netherlands Baxter B.V Kobaltweg 49 3542 CE Utrecht NEDERLAND Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Portugal Baxter Médico Farmacêutica Lda Sintra Business Park Zona Industrial da Abrunheira Edificio 10 2710-089 Sintra PORTUGAL Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use Spain Baxter S.L Poligono Industrial Sector 14 C/ Pouet de Camilo, 2 46394 Ribarroja del Turia (Valencia) ESPAÑA Extraneal Icodextrina 7,5 % Solution for peritoneal dialysis Intraperitoneal use Sweden Baxter AB Box 63 SE-164 94 Kista SVERIGE Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use United Kingdom Baxter Healthcare Ltd Caxton Way Thetford IP24 3SE UNITED KINGDOM Extraneal Icodextrin 7,5 % Solution for peritoneal dialysis Intraperitoneal use

ANNEX II LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES (EEA) Iodocasein/thiamine containing medicinal products with marketing authorisation in the European Union Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical Form Route of administration Italy TEOFARMA SRL Via Fratelli Cervi 8 Valle Salimbene 27010 Pavia PV ITALIA ANTIADIPOSO 125 mg + 12,33 mg Coated tablet Oral use

ANNEX III THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE, WITHDRAWAL PERIOD, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Applicant/Marketing Authorisation Holder Invented name Pharmaceutical form Strength Animal species Route of administration Recommended dose Withdrawal period (meat) Belgium Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Bulgaria Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Czech Republic Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Denmark Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Estonia Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Spain Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Germany Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Greece Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Hungary Fort Dodge Animal Health Poulvac Bursa Plus vakcina A.U.V. lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Ireland Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Italy Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Latvia Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Lithuania Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days The Netherlands Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Poland Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Portugal Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Romania Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Slovakia Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days Slovenia Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days United Kingdom Fort Dodge Animal Health Poulvac Bursa Plus lyophilisate for suspension in drinking water Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose Chickens from 10 days of age For oral administration in drinking water One dose from 10 days of age Zero days

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin Hospira 200 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung 200 mg Powder and solvent for solution for injection or infusion Intravenous use (injection or infusion) Intramuscular use 200 mg/vial (66,7 mg/ml) Austria Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin Hospira 400 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung 400 mg Powder and solvent for solution for injection or infusion Intravenous use (injection or infusion) Intramuscular use 400 mg/vial (133,4 mg/ml) Germany Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin Mayne Hospira 200 mg Trockensubstanz 200 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 200 mg/vial Germany Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin Mayne Hospira 400 mg Trockensubstanz 400 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 400 mg/vial Ireland Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin 200 mg Powder and Solvent for Solution for Injection or Infusion 200 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 200 mg/vial Ireland Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin 400 mg Powder and Solvent for Solution for Injection or Infusion 400 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 400 mg/vial Italy Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanina Hospira 200 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 200 mg/vial Italy Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanina Hospira 400 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 400 mg/vial Portugal Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanina Hospira 200 mg Pó e solvente para solução injectável ou solução para perfusão 200 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 200 mg/vial Portugal Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanina Hospira 400 mg Pó e solvente para solução injectável ou solução para perfusão 400 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 400 mg/vial Spain Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanina Hospira 200 mg Polvo y disolvente para solución inyectable o para perfusión 200 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 200 mg/vial Spain Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanina Hospira 400 mg Polvo y disolvente para solución inyectable o para perfusión 400 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use (injection or infusion) Intramuscular use 400 mg/vial United Kingdom Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin 200 mg Powder and Solvent for Solution for Injection or Infusion 200 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use 200 mg/vial United Kingdom Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UNITED KINGDOM Teicoplanin 400 mg Powder and Solvent for Solution for Injection or Infusion 400 mg Powder and Solvent for Solution for Injection or Infusion Intravenous use 400 mg/vial