EN Official Journal of the European Union C 56/14

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008

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

(2008/C 56/08)

— 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 11.1.2008 Methotaxol-T See Annex I See Annex I 15.1.2008 17.1.2008 Ivermectin See Annex II See Annex II 18.1.2008 18.1.2008 Ciprofloxacin Nycomed See Annex III See Annex III 21.1.2008

— 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 25.1.2008 Lumiracoxib See Annex IV See Annex IV 29.1.2008

— Revocation 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 10.1.2008 Cetirizine dihydrochloride Dermapharm 10 mg See Annex V See Annex V 11.1.2008 10.1.2008 Cetirizine dihydrochloride Copypharm 10 mg See Annex VI See Annex VI 11.1.2008 10.1.2008 Cetirizine dihydrochloride Apex 10 mg See Annex VII See Annex VII 11.1.2008 10.1.2008 Cetirizine dihydrochloride Nordic Drugs 10 mg See Annex VIII See Annex VIII 11.1.2008 10.1.2008 Clobutinol See Annex IX See Annex IX 11.1.2008

(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 PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/APPLICANT Member State Applicant or marketing authorisation holder Product invented name Pharmaceutical form Strength Indication Recommended dose Frequency and route of administration The Netherlands Eurovet Animal Health Handelsweg 25 P.O. Box 179 5530 AD Bladel Nederland Methoxasol-T Solution for oral administration Trimethoprim 20 mg/ml Sulfamethoxazole 100 mg/ml N-Methyl-2-pyrrolidone Pigs: Bronchial infections caused by Pasteurella multocida Intestinal infections caused by Escherichia coli and Salmonella spp. Urogenital infections caused by Escherichia coli Non-egg-laying chickens: Bronchial infections caused by Escherichia coli, Salmonella spp. and Pasteurella spp. Oral, via the drinking water Pigs: 2,5-5 mg trimethoprim and 12,5-25 mg sulfamethoxasole per kg body weight per day for 3-5 days Chickens: 5-12 mg trimethoprim and 25-58 mg sulfamethoxasole per kg body weight per day for 3-5 days Germany Eurovet Animal Health Handelsweg 25 P.O. Box 179 5530 AD Bladel Nederland Methoxasol-T As for The Netherlands As for The Netherlands Therapeutic treatment of infections caused by trimethoprim and sulfamethoxasole susceptible bacteria Pigs: Pasteurella multocida, Actinobacillus pleuropneumoniae, Staphylococcus hyicus, E. coli, Haemophilus spp., Pasteurella haemolytica, Salmonella cholerasuis, Salmonella thyphimurium, Streptococcus spp., Staphylococcus aureus, Staphylococcus spp. Broilers: Staphylococcus aureus, Salmonella enteritidis, E. coli Oral, via the drinking water Methoxasol-T should be administered daily in drinking water over a period of 3-4 days Pigs: 20,8 mg sulfamethoxasole + 4,2 mg trimethoprim per kg body weight per day for 3-4 days Broilers: 27,5 mg sulfamethoxasole + 5,5 mg trimethoprim per kg body weight per day for 3-4 days Austria Eurovet Animal Health Handelsweg 25 P.O. Box 179 5530 AD Bladel Nederland Methoxasol — Lösung für Schweine und Hühner As for The Netherlands As for The Netherlands For the treatment of respiratory tract infections, urogenital, gastrointestinal and skin infections caused by pathogens sensitive to trimethoprim and sulfamethoxasole in pigs and poultry (broilers) As for Germany Poland Eurovet Animal Health Handelsweg 25 P.O. Box 179 5530 AD Bladel Nederland Methoxasol As for The Netherlands As for The Netherlands For treatment of infections caused by organisms sensitive to combination of trimethoprim and sulfamethoxasole Pigs: Infections of the respiratory tract caused by Pasteurella multocida, Actinobacillus pleuropneumoniae Infections of the digestive system caused by Escherichia coli, Salmonella spp. Infections of the urinary system caused by Escherichia coli Hens: Infections of the respiratory tract caused by Escherichia coli, Salmonella spp., Pasteurella multocida Infections of the digestive system caused by Salmonella spp. Polyarthritis caused by susceptible Escherichia coli Oral, via the drinking water Pigs: 24 mg/kg b.w., equivalent to 1 litre of the drug in 500 l drinking water, for 3-4 days Hens: 33 mg/kg b.w., equivalent to 1 litre of the drug in 750 l drinking water, for 3-4 days Hungary and Lithuania Eurovet Animal Health Handelsweg 25 P.O. Box 179 5530 AD Bladel Nederland Methoxasol As for The Netherlands As for The Netherlands For the treatment of pigs and non-egg-laying chickens suffering from infectious diseases of the respiratory system caused by bacteria sensitive to sulfamethoxasole and trimethoprim (e.g. porcine A. pleuropneumoniae and gallinaceous E. coli) and for prophylactic use Oral, via the drinking water Pigs: 24 mg of active ingredient compound per kilogram of body weight or 200 ml of the medicine per 1 000 kg of body weight per day Poultry: 33 mg of active ingredient compound per kilogram of body weight or 275 ml of the medicine per 1 000 kg of body weight per day

ANNEX II NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/APPLICANT(S) Member State Marketing authorisation holder/applicant Product invented name Pharmaceutical form Strength Animal species Frequency and route of administration Recommended dose Ireland ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom Ecomectin 18,7 mg/g Oral paste for horses Oral paste A white homogenous paste Ivermectin 18,7 mg/g Horses The paste is given by oral route One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight) Belgium As above Ivermax 18,7 mg/g Oral paste for horses As above As above As above As above As above Cyprus As above Tizoval 18,7 mg/g Oral paste for horses As above As above As above As above As above Czech Republic As above Vetimec 18,7 mg/g Oral paste for horses As above As above As above As above As above Denmark As above Ecomectin 18,7 mg/g Oral paste for horses As above As above As above As above As above Finland As above Ecomectin 18,7 mg/g Oral paste for horses As above As above As above As above As above France As above Divamectin 18,7 mg/g Oral paste for horses As above As above As above As above As above Germany As above Tizoval 18,7 mg/g Oral paste for horses As above As above As above As above As above Greece As above Tizoval 18,7 mg/g Oral paste for horses As above As above As above As above As above Hungary As above Ecomectin 18,7 mg/g Oral paste for horses As above As above As above As above As above Italy As above Tizoval 18,7 mg/g Oral paste for horses As above As above As above As above As above The Netherlands As above Ivermax 18,7 mg/g Oral paste for horses As above As above As above As above As above Norway As above Tizoval 18,7 mg/g Oral paste for horses As above As above As above As above As above Portugal As above Ecomectin 18,7 mg/g Oral paste for horses As above As above As above As above As above Spain As above Ecomectin 18,7 mg/g Oral paste for horses As above As above As above As above As above Sweden As above Ecomectin 18,7 mg/g Oral paste for horses As above As above As above As above As above United Kingdom As above Animec 18,7 mg/g Oral paste for horses As above As above As above As above As above

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Marketing authorisation holder Applicant Invented name Name Strength Pharmaceutical form Route of administration Content (Concentration) United Kingdom Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Ciprofloxacin 2 mg/ml Solution for infusion Intravenous use 50 ml, 100 ml, 200 ml Denmark Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Ciprofloxacin Nycomed 2 mg/ml Solution for infusion Intravenous use 50 ml, 100 ml, 200 ml Finland Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Ciprofloxacin Nycomed 2 mg/ml Solution for infusion Intravenous use 50 ml, 100 ml, 200 ml Norway Nycomed Pharma AS Drammernsveien 852 N-1372 Asker Ciprofloxacin Nycomed 2 mg/ml Solution for infusion Intravenous use 50 ml, 100 ml, 200 ml Sweden Nycomed AB Tegeluddvägen 17-21 S-102 53 Stockholm Ciprofloxacin Nycomed 2 mg/ml Solution for infusion Intravenous use 50 ml, 100 ml, 200 ml

ANNEX IV LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS 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 Novartis Pharma GmbH Brunner Straße 59 A-1235 Wien Prexige 100 mg Film-coated tablet Oral use Austria Novartis Pharma GmbH Brunner Straße 59 A-1235 Wien Frexocel 100 mg Film-coated tablet Oral use Belgium Novartis Pharma NV Medialaan 40 bus 1 B-1800 Vilvoorde Prexigem 100 mg Film-coated tablet Oral use Belgium Novartis Pharma NV Medialaan 40 bus 1 B-1800 Vilvoorde Stellige 100 mg Film-coated tablet Oral use Czech Republic Novartis s.r.o. Pharma Nagano III. U Nákladového nádraží 10 CZ-130 00 Prague 3 Prexige 100 mg Film-coated tablet Oral use Cyprus Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU-167-SR United Kingdom Prexige 100 mg Film-coated tablet Oral use Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Prexige 100 mg Film-coated tablet Oral use Estonia Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Prexige 100 mg Film-coated tablet Oral use Finland Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Prexige 100 mg Film-coated tablet Oral use Germany Novartis Pharma GmbH Roonstraße 25 D-90429 Nuernberg Prexige 100 mg Film-coated tablet Oral use Germany Novartis Pharma GmbH Roonstraße 25 D-90429 Nuernberg Frexocel 100 mg Film-coated tablet Oral use Germany Novartis Pharma GmbH Roonstraße 25 D-90429 Nuernberg Hirzia 100 mg Film-coated tablet Oral use Germany Novartis Pharma GmbH Roonstraße 25 D-90429 Nuernberg Stellige 100 mg Film-coated tablet Oral use Greece Novartis Hellas Aebe National Road a, 12 th Km Metamorphosi Attikis GR-14451 Prexige 100 mg Film-coated tablet Oral use Greece Novartis Hellas Aebe National Road a, 12 th Km Metamorphosi Attikis GR-14451 Frexocel 100 mg Film-coated tablet Oral use Hungary Novartis Hungária Kft. Bartók Béla út 43-47 H-1114 Budapest Prexige 100 mg Film-coated tablet Oral use Iceland Novartis Healthcare A/S, c/o Vistor hf. Hörgatúni 2 IS-210 Garðabær Prexige 100 mg Film-coated tablet Oral use Latvia Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Prexige 100 mg Film-coated tablet Oral use Lithuania Novartis Finland Oy Metsanneidonkuja 10 FI-02130 Espoo Prexige 100 mg Film-coated tablet Oral use Luxembourg Novartis Pharma GmbH Roonstraße 25 D-90429 Nürnberg Prexige 100 mg Film-coated tablet Oral use Malta Novartis Pharmaceuticals UK Ltd. Frimley Business Park Frimley Camberly GU16 7SR Surrey United Kingdom Prexige 100 mg Film-coated tablet Oral use Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem Nederland Prexige 100 mg Film-coated tablet Oral use Norway Novartis Norge AS Brynsalléen 4 N-0667 Oslo Prexige 100 mg Film-coated tablet Oral use Poland Novartis Pharma GmbH Roonstraße 25 D-90429 Nurnberg Stellige 100 mg Film-coated tablet Oral use Poland Novartis Pharma GmbH Roonstraße 25 D-90429 Nurnberg Prexige 100 mg Film-coated tablet Oral use Portugal Laboratório Normal Produtos Farmacêuticos S.A Rua do Centro Empresarial Edificio 8 — Quinta da Beloura P-2710-444 Sintra Frexocel 100 mg Film-coated tablet Oral use Portugal Sociedade de Produtos Farmacêuticos Wander Lda. Rua do Centro Empresarial Edificio 8 — Quinta da Beloura P-2710-444 Sintra Hirzia 100 mg Film-coated tablet Oral use Portugal Novartis Farma, Produtos Farmacêuticos S.A. Rua do Centro Empresarial Edificio 8 — Quinta da Beloura P-2710-444 Sintra Prexige 100 mg Film-coated tablet Oral use Portugal Sanabo-Produtos Farmacêuticos Lda. Rua do Centro Empresarial Edificio 8 — Quinta da Beloura P-2710-444 Sintra Stellige 100 mg Film-coated tablet Oral use Slovakia Novartis s.r.o., Nagano III. U Nákladového nádraží 10 CZ-130 00 Praha 3 Prexige 100 mg Film-coated tablet Oral use Slovenia Novartis Pharma GmbH Roonstraße 25 D-90429 Nürnberg Frexocel 100 mg Film-coated tablet Oral use Slovenia Novartis Pharma GmbH Roonstraße 25 D-90429 Nürnberg Prexige 100 mg Film-coated tablet Oral use Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes E-764 08013 Barcelona Prexige 100 mg Film-coated tablet Oral use Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes E-764 08013 Barcelona Stellige 100 mg Film-coated tablet Oral use Sweden Novartis Sverige AB Box 1150 S-183 11 Täby Prexige 100 mg Film-coated tablet Oral use United Kingdom Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Lumiracoxib 100 mg tablets 100 mg Film-coated tablet Oral use United Kingdom Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Prexige 100 mg Film-coated tablet Oral use United Kingdom Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Frexocel 100 mg Film-coated tablet Oral use United Kingdom Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Stellige 100 mg Film-coated tablet Oral use United Kingdom Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Hirzia 100 mg Film-coated tablet Oral use

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Cetirizine dihydrochloride Dermapharm 10 mg and associated names Member State Marketing authorisation holder Product name Strength Pharmaceutical form Route of administration Austria Dermapharm GmbH Türkenstr. 25/12 A-1090 Wien Cetiderm 10 mg Filmtabletten 10 mg Film-coated tablet Oral Belgium Dermapharm AG Luise-Ullrich-Str. 6 D-82031 Grünwald Cetirizine dihydrochloride Dermapharm 10 mg filmomhulde tabletten 10 mg Film-coated tablet Oral Germany Dermapharm AG Luise-Ullrich-Str. 6 D-82031 Grünwald Cetiderm 10 mg Filmtabletten 10 mg Film-coated tablet Oral Netherlands Dermapharm AG Luise-Ullrich-Str. 6 D-82031 Grünwald Cetirizine dihydrochloride Dermapharm 10 mg tabletten 10 mg Film-coated tablet Oral

ANNEX VI LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Cetirizine dihydrochloride Copyfarm 10 mg and associated names Member State Marketing authorisation holder Product name Strength Pharmaceutical form Route of administration Denmark Copyfarm A/S, Energivej 15, POB 69 DK-5260 Odense S Cetirizin ‘Copyfarm’ 10 mg Film-coated tablet Oral Netherlands Copyfarm A/S Energivej 15 POB 69 DK-5260 Odense S Cetirizine dihydrochloride Copyfarm 10 mg 10 mg Film-coated tablet Oral Norway Copyfarm A/S Energivej 15, POB 69, DK-5260 Odense S Cetirizin Copyfarm 10 mg Film-coated tablet Oral Sweden Copyfarm A/S Energivej 15, POB 69, DK-5260 Odense S Cetirizin Copyfarm 10 mg Film-coated tablet Oral

ANNEX VII LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Cetirizine dihydrochloride APEX 10 mg and associated names Member State Marketing authorisation holder Product name Strength Pharmaceutical form Route of administration Belgium Docpharma N.V. Ambachtenlaan 13 H B-3001 Heverlee Doccetiri 10 mg Film-coated tablet Oral Luxembourg Docpharma N.V. Ambachtenlaan 13 H B-3001 Heverlee Doccetiri —10 10 mg Film-coated tablet Oral Netherlands Apex Pharmaceuticals Ltd 2nd Floor, Devlin House 36 Saint George Street Mayfair W1S 2FW London United Kingdom Cetirizine dihydrochloride — APEX 10 mg 10 mg Film-coated tablet Oral

ANNEX VIII LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Cetirizine dihydrochloride Nordic Drugs 10 mg and associated names Member State Marketing authorisation holder Product name Strength Pharmaceutical form Route of administration Denmark Nordic Drugs AB Box 300 35 S-200 61 Limhamn Gardex 10 mg Film-coated tablet Oral Finland Nordic Drugs AB Box 300 35 S-200 61 Limhamn Gardex 10 mg Film-coated tablet Oral Netherlands Nordic Drugs AB Box 300 35 S-200 61 Limhamn Cetirizine dihydrochloride Nordic Drugs 10 mg 10 mg Film-coated tablet Oral Norway Nordic Drugs AB Box 30035 S-200 61 Limhamn Acura 10 mg Film-coated tablet Oral Sweden Nordic Drugs AB Box 300 35 S-200 61 Limhamn Acura 10 mg Film-coated tablet Oral