EN Official Journal of the European Union C 18/4

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2006 to 31 December 2006

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

(2007/C 18/03)

— 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 13.12.2006 Glucomed See Annex I See Annex I 14.12.2006 13.12.2006 Agopton See Annex II See Annex II 14.12.2006

— 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 19.12.2006 Cetirizine Nordic Drugs See Annex III See Annex III 21.12.2006 19.12.2006 Cetirizine Dermapharm See Annex IV See Annex IV 21.12.2006 19.12.2006 Cetirizine Apex See Annex V See Annex V 21.12.2006

(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 PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant Invented name Strength Pharmaceutical Form Route of administration Austria — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Flexove 625 mg Tablet Oral use Belgium — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Flexove 625 mg Tablet Oral use Cyprus — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Czech Republic — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Flexove 625 mg Tablet Oral use Denmark — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Estonia — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Finland — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use France — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Germany — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Greece — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Hungary — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Flexove 625 mg Tablet Oral use Ireland — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Flexove 625 mg Tablet Oral use Italy — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Latvia — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Lithuania — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Luxemburg — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use The Netherlands — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Poland — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Portugal — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Slovakia — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Spain — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Sweden — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use United Kingdom — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Iceland — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Glucomed 625 mg Tablet Oral use Norway — Navamedic ASA Vollsveien 13 C N-1327 Lysaker Flexove 625 mg Tablet Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Product name Strength Pharmaceutical form Route of administration Austria Takeda Pharma Ges.m.b.H. Seidengasse 33-35 A-1070 Vienna AGOPTON 15 mg Capsule Oral use AGOPTON 30 mg Capsule Oral use AGOPTON Rapid 15 mg Oro-dispersible tablet Oral use AGOPTON Rapid 30 mg Oro-dispersible tablet Oral use Belgium Sanofi-Synthelabo SA NV Dobbelenberg 5, Avenue de la Metrologie B-1130 Brussels DAKAR 15mg Capsule Oral use DAKAR 30 mg Capsule Oral use NIBITOR 30 mg Capsule Oral use Denmark Wyeth ab Box 1822 S-171 24 Solna LANZO 15 mg Capsule Oral use LANZO 30 mg Capsule Oral use Finland Wyeth AB Box 1822 S-171 24 Solna LANZO 30 mg Capsule Oral use LANZO 15 mg Oro-dispersible tablet Oral use LANZO 30 mg Oro-dispersible tablet Oral use France Laboratoires Takeda SA 15, quai de Dion Bouton F-92816 Puteaux Cedex OGAST 15 mg Capsule Oral use OGAST 30 mg Capsule Oral use Sanofi-Aventis 46 quai de la Râpée F-75601 Paris Cedex 12 LANZOR 15 mg Capsule Oral use LANZOR 30 mg Capsule Oral use Germany Takeda Pharma GmbH Viktoriaallee 3-5 D-52066 Aachen AGOPTON 15 mg Capsule Oral use AGOPTON 30 mg Capsule Oral use LANZOR 15 mg Capsule Oral use LANZOR 30 mg Capsule Oral use Greece Vianex S.A. Tatoiou Street EL-146 71 Nea Erythrea, Athens LAPRAZOL 15 mg Capsule Oral use LAPRAZOL 30 mg Capsule Oral use LAPRAZOL FasTab 15 mg Oro-dispersible tablet Oral use LAPRAZOL FasTab 30 mg Oro-dispersible tablet Oral use Hungary Gedeon Richter Gyomrói út 19-21 H-1103 Budapest LANSONE 30 mg Capsule Oral use Ireland John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH United Kingdom ZOTON 15 mg Capsule Oral use ZOTON 30 mg Capsule Oral use ZOTON FasTab 15 mg Oro-dispersible tablet Oral use ZOTON FasTab 30 mg Oro-dispersible tablet Oral use Cyanamid of Great Briain Ltd. Fareham Road GOSPORT Hampshire PO13 0AS United Kingdom ZOTON 30mg Gastro-resistant granules for oral suspension Oral use Italy Takeda Italia Farmaceutici S.p.A. Via Elio Vittorini 129 I-00144 Roma LANSOX 15 mg Capsule Oral use LANSOX 30 mg Capsule Oral use LANGAST 15 mg Capsule Oral use LANGAST 30 mg Capsule Oral use LANSOX 15 mg Oro-dispersible tablet Oral use LANSOX 30 mg Oro-dispersible tablet Oral use Sigma-Tau S.p.A. Via Pontina km. 30,400 I-00040 Pomezia, Roma LIMPIDEX 15 mg Capsule Oral use LIMPIDEX 30 mg Capsule Oral use LIMPIDEX 15 mg Oro-dispersible tablet Oral use LIMPIDEX 30 mg Oro-dispersible tablet Oral use Wyeth Lederle S.p.A. Via Nettunense, 90 I-04011 Aprilia (LT) ZOTON 15 mg Capsule Oral use ZOTON 30 mg Capsule Oral use ZOTON 15 mg Oro-dispersible tablet Oral use ZOTON 30 mg Oro-dispersible tablet Oral use Luxembourg Sanofi-Synthelabo SA NV Dobbelenberg, 5, Avenue de la Metrologie B-1130 Brussels DAKAR 15 mg Capsule Oral use DAKAR 30 mg Capsule Oral use Netherlands Sanofi-Synthelabo B.V./Aventis Pharma B.V. Kampenringweg 45 D-E (toren D en E) 2803 PE Gouda Nederland PREZAL 15 mg Capsule Oral use PREZAL 30 mg Capsule Oral use Portugal Seber Portuguesa Farmacêutica, SA Rua Norberto de Oliveira, 1 a 5 P-2620-111 Póvoa de Santo Adrião OGASTO 15 mg Capsule Oral use OGASTO 30 mg Capsule Oral use OGASTO 15 mg Oro-dispersible tablet Oral use OGASTO 30 mg Oro-dispersible tablet Oral use Spain Almirall Prodesfarma, S.A. General Mitre, 151 E-08022 Barcelona OPIREN 15 mg Capsule Oral use OPIREN 30 mg Capsule Oral use BAMALITE 15 mg Capsule Oral use BAMALITE 30 mg Capsule Oral use OPIREN Flas 15 mg Oro-dispersible tablet Oral use OPIREN Flas 30 mg Oro-dispersible tablet Oral use BAMALITE Flas 15 mg Oro-dispersible tablet Oral use BAMALITE Flas 30 mg Oro-dispersible tablet Oral use Sweden Wyeth AB Box 1822 S-171 24 Solna LANZO 15 mg Capsule Oral use LANZO 30 mg Capsule Oral use LANZO 15 mg Oro-dispersible tablet Oral use LANZO 30 mg Oro-dispersible tablet Oral use United Kingdom John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH United Kingdom ZOTON 15 mg Capsule Oral use ZOTON 30 mg Capsule Oral use ZOTON 30 mg Gastro-resistant granules for oral suspension Oral use ZOTON FasTab 15 mg Oro-dispersible Tablet Oral use ZOTON FasTab 30 mg Oro-dispersible Tablet Oral use Iceland Wyeth AB Box 1822 S-171 24 Solna LANZO 15 mg Capsule Oral use LANZO 30 mg Capsule Oral use ZOTON 15 mg Capsule Oral use ZOTON 30 mg Capsule Oral use LANZO 15 mg Oro-dispersible tablet Oral use LANZO 30 mg Oro-dispersible tablet Oral use Norway Wyeth AB Box 1822 S-171 24 Solna LANZO 15 mg Capsule Oral use LANZO 30 mg Capsule Oral use LANZO 15 mg Oro-dispersible tablet Oral use LANZO 30 mg Oro-dispersible tablet Oral use

ANNEX III LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, 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 Geijersgatan 4 C S-200 61 Limhamn Gardex 10 mg Film coated tablet Oral Finland Nordic Drugs AB Geijersgatan 2A Box 30035 S-200 61 Limhamn Gardex 10 mg tabletti, kalvopäällysteinen 10 mg Film coated tablet Oral Netherlands Nordic Drugs AB Box 30035 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

ANNEX IV LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, 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