EN Official Journal of the European Union C 144/11

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2007/C 144/07)

— 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 22.5.2007 Doxyprex See Annex I See Annex I 24.5.2007 22.5.2007 Thelin This Decision is addressed to the Member States This Decision is addressed to the Member States 24.5.2007 29.5.2007 Xefo See Annex II See Annex II 30.5.2007 30.5.2007 Remicade This Decision is addressed to the Member States This Decision is addressed to the Member States 31.5.2007

— 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 2.5.2007 Alendros 70 See Annex III See Annex III 4.5.2007

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

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

ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, 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 Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia Industrial Veterinaria, S.A. Esmeralda, 19-4o E-08950 Esplugues de Llobregat (Barcelona) DOXYPREX Premix 100 mg/g Pigs (after weaning) In feed use 10 mg/kg .bw

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Content Austria Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Artok 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Lornox 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Artok 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo Rapid 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Lornoxicam ‘Nycomed’ 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Belgium Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo Acute 8 mg Film-coated tablet Oral 8 mg Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Bulgaria Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Czech Republic Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Denmark Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Lornoxicam ‘Nycomed’ 4 mg Film-coated tablet Oral 4 mg Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Lornoxicam ‘Nycomed’ 8 mg Film-coated tablet Oral 8 mg Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Xefo Rapid 8 mg Film-coated tablet Oral 8 mg Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Lornoxicam ‘Nycomed’ 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Estonia Nycomed SEFA Jaama 55B EE-63308 Pölva Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed SEFA Jaama 55B EE-63308 Pölva Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed SEFA Jaama 55B EE-63308 Pölva Xefo Rapid 8 mg Film-coated tablet Oral 8 mg Nycomed SEFA Jaama 55B EE-63308 Pölva Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Germany Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Lornoxicam ‘Nycomed’ 4 mg Film-coated tablet Oral 4 mg Nycomed Pharma GmbH Edisonstraße 16 D-85716 Unterschleissheim Telos 4 mg Film-coated tablet Oral 4 mg Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Lornoxicam ‘Nycomed’ 8 mg Film-coated tablet Oral 8 mg Nycomed Pharma GmbH Edisonstraße 16 D-85716 Unterschleissheim Telos 8 mg Film-coated tablet Oral 8 mg Greece Nycomed Hellas S.A. Λεωφ. Κηφισίας 196 GR-152 31 Αθήνα Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Hellas S.A. Λεωφ. Κηφισίας 196 GR-152 31 Αθήνα Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Hellas S.A. Λεωφ. Κηφισίας 196 GR-152 31 Αθήνα Xefo Rapid 8 mg Film-coated tablet Oral 8 mg Nycomed Hellas S.A. Λεωφ. Κηφισίας 196 GR-152 31 Αθήνα Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Hungary Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Italy Nycomed Italy S.r.l. Via Carducci 125 Edificio A I-20099 Sesto San Giovanni Taigalor 8 mg Film-coated tablet Oral 8 mg Nycomed Italy S.r.l. Via Carducci 125 Edificio A I-20099 Sesto San Giovanni Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Italy S.r.l. Via Carducci 125 Edificio A I-20099 Sesto San Giovanni Taigalor 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Nycomed Italy S.r.l. Via Carducci 125 Edificio A I-20099 Sesto San Giovanni Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Latvia Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed SEFA Jaama 55B EE-63308 Pölva Xefo Rapid 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Lithuania Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed SEFA Jaama 55B EE-63308 Pölva Xefo Rapid 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Luxembourg Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo Acute 8 mg Film-coated tablet Oral 8 mg Nycomed Christians Gentsesteenweg 615 B-1080 Brussel Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Portugal Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Acabel 4 mg Film-coated tablet Oral 4 mg Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Bosporon 4 mg Film-coated tablet Oral 4 mg Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Acabel 8 mg Film-coated tablet Oral 8 mg Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Bosporon 8 mg Film-coated tablet Oral 8 mg Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Acabel Rapid 8 mg Film-coated tablet Oral 8 mg Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Bosporon Rapid 8 mg Film-coated tablet Oral 8 mg Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Acabel 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Euro-Labor SA Rua Alfredo da Silva n.o 16 P-2610-016 Amadora Bosporon 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Romania Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed Austria GmbH St. Peter Straße 25 A-4020 Linz Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Spain Laboratorios Andromaco S.A. Doctor Zamenhof 36 E-29027 Madrid Acabel 4 mg Film-coated tablet Oral 4 mg Tedec Meiji Farma, S.A. Ctra. M-300 Km 30,500 E-28802 Alcalá de Henares, Madrid Bosporon 4 mg Film-coated tablet Oral 4 mg Laboratorios Andromaco S.A. Doctor Zamenhof 36 E-29027 Madrid Acabel 8 mg Film-coated tablet Oral 8 mg Tedec Meiji Farma, S.A. Ctra. M-300 Km 30,500 E-28802 Alcalá de Henares, Madrid Bosporon 8 mg Film-coated tablet Oral 8 mg Laboratorios Andromaco S.A. Doctor Zamenhof 36 E-29027 Madrid Acabel Rapid 8 mg Film-coated tablet Oral 8 mg Tedec Meiji Farma, S.A. Ctra. M-300 Km 30,500 E-28802 Alcalá de Henares, Madrid Bosporon Rapid 8 mg Film-coated tablet Oral 8 mg Laboratorios Andromaco S.A. Doctor Zamenhof 36 E-29027 Madrid Acabel 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg Sweden Nycomed AB Tegeluddsvägen 17-21 S-102 53 Stockholm Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed AB Tegeluddsvägen 17-21 S-102 53 Stockholm Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed AB Tegeluddsvägen 17-21 S-102 53 Stockholm Xefo Akut 8 mg Film-coated tablet Oral 8 mg Nycomed AB Tegeluddsvägen 17-21 S-102 53 Stockholm Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg United Kingdom Nycomed UK Ltd The Magdalen Centre Oxford Science Park OX4 4GA Oxford United Kingdom Xefo 4 mg Film-coated tablet Oral 4 mg Nycomed UK Ltd The Magdalen Centre Oxford Science Park OX4 4GA Oxford United Kingdom Xefo 8 mg Film-coated tablet Oral 8 mg Nycomed UK Ltd The Magdalen Centre Oxford Science Park OX4 4GA Oxford United Kingdom Xefo 4 mg/ml Powder and solvent for solution for injection Intravenous use/Intramuscular use 8 mg