Member State Marketing Authorisation Holder (Invented) Strength Pharmaceutical form Route of administration. Novartis Pharma NV
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1 ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
2 Member State Marketing Authorisation Holder (Invented) Strength Pharmaceutical form Route of administration name Austria Brunner Straße Wien Austria Austria Belgium Belgium Czech Republic Cyprus Brunner Straße Wien Austria Novartis Pharma NV Medialaan 40 bus 1 B-1800 Vilvoorde Belgium Novartis Pharma NV Medialaan 40 bus 1 B-1800 Vilvoorde Belgium Novartis s.r.o. Pharma Nagano III. U Nákladového nádraží Prague 3 Czech Republic Novartis Pharmaceuticals Ltd Surrey GU-167-SR
3 Denmark Estonia Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø Denmark Novartis OY Metsänneidonkuja 10 FIN Espoo Novartis OY Metsänneidonkuja 10 FIN Espoo Roonstr. 25 D Nuernberg Roonstr. 25 D Nuernberg
4 Greece Greece Hungary Iceland Roonstr. 25 D Nuernberg Roonstr. 25 D Nuernberg Novartis Hellas Aebe National Road a, 12 th Km Metamorphosi Attikis Greece Novartis Hellas Aebe National Road a, 12 th Km Metamorphosi Attikis Greece Novartis Hungária Kft Budapest Bartók Béla út Hungary Novartis Healthcare A/S, c/o Vistor hf., Hörgatúni 2, 210 Garðabær Iceland Hirzia 100 mg film-coated tablet oral use
5 Latvia Lithuania Luxembourg Malta Nederlands Norway Poland Novartis Oy, Metsänneidonkuja 10, FI-02130, Espoo Novartis Oy, Metsanneidonkuja-10, FIN Espoo Roonstrasse 25 D Nürnberg Novartis Pharmaceuticals Ltd., Frimley, Camberly, GU16 7SR Surrey Novartis Pharma B.V. Raapopseweg DP Arnhem Nederland Novartis Norge AS Brynsalléen Oslo Norway Roonstrasse 25 D Nurnberg Prexige 100 mg film coated tablet oral use
6 Poland Roonstrasse 25 D Nurnberg Laboratório Normal Produtos Farmacêuticos, S.A Rua do Centro Empresarial- Edificio 8 - Quinta da Beloura Sintra Sociedade de Produtos Farmacêuticos Wander, Lda. Rua do Centro Empresarial- Edificio 8 - Quinta da Beloura Sintra Novartis Farma, Produtos Farmacêuticos, S.A. Rua do Centro Empresarial- Edificio 8 - Quinta da Beloura Sintra Sanabo-Produtos Farmacêuticos, Lda. Rua do Centro Empresarial- Edificio 8 - Quinta da Beloura Sintra Hirzia 100 mg film-coated tablet oral use
7 Slovakia Slovenia Slovenia Spain Spain Sweden United Novartis s.r.o., Nagano III. U Nákladového nádraží Praha 3 Czech Republic, Roonstrasse 25, Nürnberg, Roonstrasse Nürnberg Novartis Farmaceutica S.A.Gran Via de les Corts Catalanes, Barcelona Novartis Farmaceutica S.A.Gran Via de les Corts Catalanes, Barcelona Novartis Sverige AB Box Täby Sweden Novartis Pharmaceuticals Limited Frexocel 100 mg film -coated tablet oral use Lumiracoxib 100 mg tablets 100 mg film-coated tablet oral use
8 United United United United Novartis Pharmaceuticals Limited, Novartis Pharmaceuticals Limited, Novartis Pharmaceuticals Limited, Novartis Pharmaceuticals Limited, Hirzia 100 mg film-coated tablet oral use
Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Form Route of administration Novartis Pharma GmbH
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 EU/EEA Austria Austria Austria
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