Annex I List of the Names, Pharmaceutical Forms, Strengths of the Medicinal Products, Routes of Administration, Marketing Author
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ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Austria Nycomed Pharma GmbH Pantoloc 20 mg - 20 mg Gastro-resistant oral use Euro Plaza Gebäude F Filmtabletten tablet Technologiestrasse 5 1120 Vienna Austria Austria Nycomed Pharma GmbH Pantoloc 40 mg - 40 mg Gastro-resistant oral use Euro Plaza Gebäude F Filmtabletten tablet Technologiestrasse 5 1120 Vienna Austria Austria Nycomed Pharma GmbH Pantoloc 40 mg - 40 mg Powder for solution intravenous use 40 mg Euro Plaza Gebäude F Trockenstech- for injection Technologiestrasse 5 ampulle 1120 Vienna Austria Austria Nycomed Austria GmbH Zurcal 20 mg -Filmtabletten 20 mg Gastro-resistant oral use St. Peter Strasse 25 tablet 4020 Linz Austria Austria Nycomed Austria GmbH Zurcal 40 mg -Filmtabletten 40 mg Gastro-resistant oral use St. Peter Strasse 25 tablet 4020 Linz Austria Austria Nycomed Austria GmbH Zurcal 40 mg -Trockenstech- 40 mg Powder for solution intravenous use 40 mg St. Peter Strasse 25 ampulle for injection 4020 Linz Austria 2 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Belgium Nycomed Belgium SCA/CVA Pantozol 40 mg Gastro-resistantoral use Gentsesteenweg 615 tablet 1080 Brussels Belgium Belgium Nycomed Belgium Pantozol 20 mg Gastro-resistant oral use SCA/CVA tablet Gentsesteenweg 615 1080 Brussels Belgium Belgium Nycomed Belgium Pantozol IV 40 mg Powder for solution intravenous use 40 mg SCA/CVA for injection Gentsesteenweg 615 1080 Brussels Belgium Belgium Nycomed Belgium SCA/CVA Zurcale 40 mg Gastro-resistantoral use Gentsesteenweg 615 tablet 1080 Brussels Belgium Belgium Nycomed Belgium SCA/CVA Zurcale 20 mg 20 mg Gastro-resistant oral use Gentsesteenweg 615 tablet 1080 Brussels Belgium Belgium Nycomed Belgium SCA/CVA Zurcale IV 40 mg Powder for solution intravenous use 40 mg Gentsesteenweg 615 for injection 1080 Brussels Belgium 3 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Bulgaria Nycomed GmbH Controloc 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Bulgaria Nycomed GmbH Controloc 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Cyprus Mundipharma Pharmaceuticals Ltd. Controloc 20 mg Gastro-resistant oral use Othellos str. 13 tablet Dhali Industrial Zone 1685 Nicosia Cyprus Cyprus Mundipharma Pharmaceuticals Ltd. Controloc 40 mg Gastro-resistant oral use Othellos str. 13 tablet Dhali Industrial Zone 1685 Nicosia Cyprus Cyprus Mundipharma Pharmaceuticals Ltd. Controloc i.v. 40 mg Powder for solution intravenous use 40 mg Othellos str. 13 for injection Dhali Industrial Zone 1685 Nicosia Cyprus 4 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Czech Nycomed GmbH Controloc 20 mg 20 mg Gastro-resistant oral use Republic Byk-Gulden-Str.2 tablet 78467 Konstanz Germany Czech Nycomed GmbH Controloc 40 mg 40 mg Gastro-resistant oral use Republic Byk-Gulden-Str.2 tablet 78467 Konstanz Germany Czech Nycomed GmbH Controloc i.v. 40 mg Powder for intravenous use 40 mg Republic Byk-Gulden-Str.2 solution for 78467 Konstanz injection Germany Denmark Nycomed Denmark ApS Pantoloc 20 mg Gastro-resistant oral use Langebjerg 1 tablet 4000 Roskilde Denmark Denmark Nycomed Denmark ApS Pantoloc 40 mg Gastro-resistantoral use Langebjerg 1 tablet 4000 Roskilde Denmark Denmark Nycomed Denmark ApS Pantoloc 40 mg Powder for solution intravenous use 40 mg Langebjerg 1 for injection 4000 Roskilde Denmark 5 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Estonia Nycomed GmbH Controloc 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Konstanz Germany Estonia Nycomed GmbH Controloc 40 mg 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Konstanz Germany Finland Nycomed GmbH Somac 20 mg enterotabletti 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Finland Nycomed GmbH Somac 40 mg enterotabletti 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Finland Nycomed GmbH Somac 40 mg injektiokuiva- 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 aine, liuosta varten for injection 78467 Constance Germany France Nycomed France Eupantol 20 mg, 20 mg Gastro-resistant oral use 13, rue Watt comprimé gastro- tablet 75013 Paris résistant France France Nycomed France Eupantol 40 mg, 40 mg Gastro-resistant oral use 13, rue Watt comprimé gastro- tablet 75013 Paris résistant France 6 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA France Nycomed France Eupantol 40 mg poudre pour 40 mg Powder for solution intravenous use 40 mg 13, rue Watt solution injectable IV for injection 75013 Paris France France Nycomed France Inipomp 20 mg, 20 mg Gastro-resistant oral use 13, rue Watt comprimé gastro- tablet 75013 Paris résistant France France Nycomed France Inipomp 40 mg, 40 mg Gastro-resistant oral use 13, rue Watt comprimé gastro- tablet 75013 Paris résistant France France Nycomed France Inipomp 40 mg; poudre pour 40 mg Powder for solution intravenous use 40 mg 13, rue Watt IV for injection 75013 Paris France France Nycomed France Pantec 20 mg, comprimé 20 mg Gastro-resistant oral use 13, rue Watt gastro- tablet 75013 Paris résistant France France Nycomed France Pantec 40 mg, 40 mg Gastro-resistant oral use 13, rue Watt comprimé gastro- tablet 75013 Paris résistant France France Nycomed France Pantipp 20 mg, 20 mg Gastro-resistant oral use 13, rue Watt comprimé gastro- tablet 75013 Paris résistant France 7 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA France Nycomed France Pantipp 40 mg, 40 mg Gastro-resistant oral use 13, rue Watt comprimé gastro- tablet 75013 Paris résistant France Germany Nycomed GmbH Pantoprazol NYC 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Germany Nycomed GmbH Pantoprazol NYC 40 mg 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Germany Nycomed GmbH Pantoloc i.v. 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 for injection 78467 Constance Germany Germany Nycomed GmbH Pantoprazol 20 mg Byk 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Germany Nycomed GmbH Pantoprazol-Byk i.v. 40 mg Powder for solution intravenous use Byk-Gulden-Str.2 for injection 78467 Constance Germany Germany Nycomed GmbH Pantozol 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany 8 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Germany Nycomed GmbH Pantozol 40 mg 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Germany Nycomed GmbH Pantozol i.v. 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 for injection 78467 Constance Germany Germany Nycomed GmbH PantoLomberg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 20 mg tablet 78467 Constance Germany Germany Nycomed GmbH Pantoprazole Lomberg 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Germany Nycomed GmbH Rifun 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Germany Nycomed GmbH Rifun 40 mg 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Germany Byk Tosse Arzneimittel GmbH, Zurcal S 20 mg 20 mg Gastro-resistant oral use Moltkestr. 4 magensaftresistente Tabletten tablet 78467 Constance Germany 9 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Germany Byk Tosse Arzneimittel GmbH, Zurcal S 40 mg 40 mg Gastro-resistant oral use Moltkestr. 4 magensaftresistente Tabletten tablet 78467 Constance Germany Greece Sanofi-Aventis Greece Controloc 20 mg 20 mg Gastro-resistant oral use 348, Syngrou Avenue tablet Building A 176 74 Kallithea Greece Greece Sanofi-Aventis Greece Controloc 40 mg Gastro-resistant oral use 348, Syngrou Avenue tablet Building A 176 74 Kallithea Greece Greece Sanofi-Aventis Greece Controloc i.v. 40 mg Powder for solution intravenous use 40 mg 348, Syngrou Avenue for injection Building A 176 74 Kallithea Greece Greece Nycomed Hellas S.A. Zurcazol 20 mg 20 mg Gastro-resistant oral use 196, Kifissias Ave. tablet 152 31 Chalandri Athens Greece Greece Nycomed Hellas S.A. Zurcazol 40 mg Gastro-resistant oral use 196, Kifissias Ave. tablet 152 31 Chalandri Athens Greece 10 Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA Greece Nycomed Hellas S.A. Zurcazol i.v. 40 mg Powder for solution intravenous use 40 mg 196, Kifissias Ave. for injection 152 31 Chalandri Athens Greece Hungary Nycomed GmbH Controloc 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Konstanz