EN Official Journal of the European Union C 241/6

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2005 to 31 August 2005

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

(2005/C 241/02)

— 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 09.08.2005 Calcium art 30 See Annex I See Annex I 22.08.2005 09.08.2005 Crestor art 29 See Annex II See Annex II 22.08.2005 19.08.2005 SSRIs-SNRIs art 31 See Annex III See Annex III 25.08.2005

(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, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Novartis Consumer Health-Gebro GmbH, Bahnhofbichl 13 6391 Fieberbrunn/Tirol, Austria Attn: Dr. D. Werner Attn: Dr. Volker Eisenreich Mega-Calcium-Brausetabletten Ca 1 000 mg Effervescent tablets Oral use Austria Novartis Consumer Health-Gebro GmbH, Bahnhofbichl 13 6391 Fieberbrunn/Tirol, Austria Attn: Dr. D. Werner Attn: Dr. Volker Eisenreich Calcium ‘Sandoz’ forte - Brausetabletten Ca 500 mg Effervescent tablets Oral use Belgium Novartis Consumer Health SA/NV Medialaan, 30 Bus 5 - 1800 VILVOORDE Belgium Attn: Mr Pieter De Pourcq SANDOZ CALCIUM, comprimés effervescents Ca 500 mg Effervescent tablets Oral use Cyprus Varnavas Hadjipanayis Ltd. 7A Androcleous Str. 1060 Nicosia Cyprus Attn: G. Tseriotis Calcium-Sandoz® forte 500 mg Ca 500 mg Effervescent tablets Oral use Czech Republic Novartis s.r.o. Divison Consumer Health Nagano III. U Nákladového nádraží 10 130 00 Praha3 Czech Republic Attn: Ugo Di Francesco & Dr. H. Blehova CALCIUM-SANDOZ® FF 1 000 mg Ca 1 000 mg Effervescent tablets Oral use Czech Republic Novartis s.r.o. Divison Consumer Health Nagano III. U Nákladového nádraží 10 130 00 Praha3 Czech Republic Attn: Ugo Di Francesco & Dr. H. Blehova CALCIUM-SANDOZ® FORTE 500 mg Ca 500 mg EEffervescent tablets Oral use Denmark Novartis Healthcare A/S, Lyngbyvej 172, 2100 Kobenhavn, Denmark Attn: J. Grevsen Calcium-Sandoz, brusetabletter Ca 500 mg Effervescent tablets Oral use Finland Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finland Attn: Mr Torbjörn Sonck & Ms Eeva Liisa Kärkkäinen Mega-Calcium 1 g Ca2+ poretabletti Ca 1 000 mg Effervescent tablets Oral use Finland Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finland Attn: Mr Torbjörn Sonck & Ms Eeva Liisa Kärkkäinen Calcium-Sandoz 500 mg Ca2+ poretabletti Ca 500 mg Effervescent tablets Oral use France Novartis Santé Familiale S.A.S., 14 Bld Richelieu 92845 Rueil Malmaison Cedex, France Attn: M. Lours CALCIUM SANDOZ 500 mg, comprimés effervescents Ca 500 mg Effervescent tablets Oral use Germany Novartis Consumer Health GmbH, Zielstattstrasse 40, 81379 München, Germany Attn: Dr. M. Unkauf Calcium-Sandoz® fortissimum 1 000 mg Ca 1 000 mg Effervescent tablets Oral use Germany Novartis Consumer Health GmbH, Zielstattstrasse 40, 81379 München, Germany Attn: Dr. M. Unkauf Calcium-Sandoz® forte 500 mg Ca 500 mg Effervescent tablets Oral use Greece Novartis (Hellas) AEBE 12o Km National Road No1, 14451 Metamorfosis Attikis, Greece Attn: C. Hatzidakis Mega-Calcium® Sandoz Ca 1 000 mg Effervescent tablets Oral use Hungary Novartis Hungária Kft. Consumer Health 1027 Budapest Horvát u. 14-24. II. Emelet Postacím: 1525 Budapest, Pf. 118 Hungary Attn: P. Miko Calcium-Sandoz pezsgõtabletta Ca 500 mg Effervescent tablets Oral use Iceland Novartis Healthcare A/S, Lyngbyvej 172, 2100 Kobenhavn, Denmark Attn: J. Grevsen Calcium-Sandoz, freyðitöflur Ca 500 mg Effervescent tablets Oral use Ireland Novartis Consumer Health UK Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB United Kingdom Attn: Dr Jacinta Keogh-Bennett Sandocal 1000 Ca 1 000 mg Effervescent tablets Oral use Italy Novartis Consumer Health S.p. A, Largo U. Boccioni, 1 21040 Origgio (VA), Italy Attn: Ms Maria Carla Baggio & Mr Carlo Candiani CALCIUM-SANDOZ 1 000 mg compresse effervescenti Ca 1 000 mg Effervescent tablets Oral use Italy Novartis Consumer Health S.p. A, Largo U. Boccioni, 1 21040 Origgio (VA), Italy Attn: Ms Maria Carla Baggio & Mr Carlo Candiani CALCIUM-SANDOZ 500 mg compresse effervescenti Ca 500 mg Effervescent tablets Oral use Luxembourg Novartis Consumer Health SA/NV Medialaan, 30 Bus 5 - 1800 VILVOORDE Belgium Attn: Mr Pieter De Pourcq Calcium-Sandoz® fortissimum 1 000 mg Ca 1 000 mg Effervescent tablets Oral use The Netherlands Novartis Consumer Health B. V, Claudius Prinsenlaan 140 4818 CP Breda, Netherlands Attn: W. VanBerckel Sandoz Calcium fortissimum, bruistabletten Ca 1 000 mg Effervescent tablets Oral use The Netherlands Novartis Consumer Health B. V, Claudius Prinsenlaan 140 4818 CP Breda, Netherlands Attn: W. VanBerckel Sandoz Calcium forte, bruistabletten Ca 500 mg Effervescent tablets Oral use Norway Novartis Norge A/S Consumer Health, Brynsalléen 4 Postboks 237 Økern 0510 Oslo, Norway Attn: J. Lam Calcium-Sandoz® 500 mg effervescent Ca 500 mg Effervescent tablets Oral use Poland Novartis Consumer Health GmbH, Zielstattstrasse 40, 81379 München, Germany Attn: Mr Martin Bischof & Dr. Markus Unkauf CALCIUM-SANDOZ Forte Ca 500 mg Effervescent tablets Oral use Portugal NCH Produtos Farmaceuticos e Nutriçao Lda, Av. Poeta Mistral no 2-2o, 1069-172 Lisboa, Portugal Attn: Ms Maria do Céu Correia & Ms Margarida Moraes CALCIUM-SANDOZ® FORTE 500 mg Ca 500 mg Effervescent tablets Oral use Slovakia Novartis s.r.o. Divison Consumer Health Nagano III. U Nákladového nádraží 10 130 00 Praha3 Czech Republic Attn: Ugo Di Francesco & Dr. H. Blehova CALCIUM-SANDOZ® Forte Ca 500 mg Effervescent tablets Oral use Slovakia Novartis s.r.o. Divison Consumer Health Nagano III. U Nákladového nádraží 10 130 00 Praha3 Czech Republic Attn: Ugo Di Francesco & Dr. H. Blehova CALCIUM-SANDOZ® FF 1 000 mg Ca 1 000 mg Effervescent tablets Oral use Slovenia Medis, d.o.o. P.O. 2646, Brnčičeva 1 1000 Ljubljana, Slovenia Mr Tone Strnad Calcium-Sandoz Forte Ca 500 mg Effervescent tablets Oral use Spain Novartis Consumer Health SA, Gran Via Corts Catalanes 764, 08013 Barcelona Spain Attn: A. Catasus Calcium Sandoz Forte comprimidos efervescentes Ca 500 mg Effervescent tablets Oral use Sweden Novartis Sverige AB Consumer Health, Kemistvägen 1B, PO Box 1150 183 11 Täby, Sweden Attn: R. Sigerud Calcium-Sandoz 1 g brustablett Ca 1 000 mg Effervescent tablets Oral use Sweden Novartis Sverige AB Consumer Health, Kemistvägen 1B, PO Box 1150 183 11 Täby, Sweden Attn: R. Sigerud Calcium-Sandoz 500 mg brustablett Ca 500 mg Effervescent tablets Oral use United Kingdom Novartis Consumer Health UK Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB United Kingdom Attn: Dr Jacinta Keogh-Bennett SANDOCAL 1000 Ca 1 000 mg Effervescent tablets Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holders/Applicants Invented Name Strength Pharmaceutical Form Route of administration Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 Postfach 153, A-1037 Vienna Austria Crestor 5 mg Film coated tablet oral use Belgium AstraZeneca Belgium Egide Van Ophemstraat 110 B-1180 Brussels, Belgium Crestor 5 mg Film coated tablet oral use Denmark AstraZeneca A/SRoskildevej 22 DK-2620 Albertslund Denmark Crestor 5 mg Film coated tablet oral use Finland AstraZeneca Oy Luomanportti 3 FIN-02200 Espoo Finland Crestor 5 mg Film coated tablet oral use France AstraZeneca France Place Renault F-92844 Rueil-Malmaison Cedex France Crestor 5 mg Film coated tablet oral use Greece AstraZeneca S A 4, Theotokopoulou & Astronafton str GR-151 25 Maroussi Athens Greece Crestor 5 mg Film coated tablet oral use Iceland AstraZeneca A/S Roskildevej 22 DK-2620 Albertslund Denmark Crestor 5 mg Film coated tablet oral use Ireland AstraZeneca UK Limited Horizon Place, 600 Capability Green, Luton, Bedfordshire LU1 3LU England UK Crestor 5 mg Film coated tablet oral use Italy AstraZeneca Netherlands P O Box 599 NL-2700 An Zoetermeer Netherlands Crestor 5 mg Film coated tablet oral use Luxembourg AstraZeneca Belgium Egide Van Ophemstraat 110 B-1180 Brussels Belgium Crestor 5 mg Film coated tablet oral use The Netherlands AstraZeneca Netherlands P O Box 599 NL-2700 An Zoetermeer Netherlands Crestor 5 mg Film coated tablet oral use Portugal AstraZeneca – Produtos Farmacéuticos, Lda Rua Humberto Madeira 7 Valejas 2745-663 Barcarena Portugal Crestor 5 mg Film coated tablet oral use Sweden AstraZeneca AB 151 85 Södertälje Södertälje Sweden Crestor 5 mg Film coated tablet oral use UK AstraZeneca UK Limited Horizon Place, 600 Capability Green, Luton, Bedfordshire LU1 3LU England UK Crestor 5 mg Film coated tablet oral use