Annex I List of the Names, Pharmaceutical Forms, Strengths of the Medicinal Products, Routes of Administration, Marketing Author

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

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

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

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

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

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

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

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

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

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 Germany

Hungary Nycomed GmbH 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 Controloc 40 mg tablet 78467 Constance Germany Hungary Nycomed GmbH Controloc i.v. 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 for injection 78467 Constance Germany Ireland Nycomed GmbH Protium 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Ireland Nycomed GmbH Protium 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Ireland Nycomed GmbH Protium i.v. 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 for injection 78467 Constance Germany

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Italy Nycomed Italia S.r.l Pantecta 40 mg Gastro-resistant oral use via Libero Temolo 4 tablet 20126 Milan Italy Italy Nycomed Italia S.r.l Pantecta 20 mg Gastro-resistant oral use via Libero Temolo 4 tablet 20126 Milan Italy Italy Almirall S.p.A Pantopan 40 mg Gastro-resistant oral use via Messina, 38 Torre C tablet 20154 Milan Italy Italy Almirall S.p.A Pantopan 20 mg Gastro-resistant oral use via Messina, 38 Torre C tablet 20154 Milan Italy

Italy Nycomed S.p.A. Pantorc 40 mg Gastro-resistantoral use Via Temolo 4 tablet 20126 Milan Italy Italy Nycomed S.p.A. Pantorc 20 mg Gastro-resistant oral use Via Temolo 4 tablet 20126 Milan Italy Italy Nycomed S.p.A. Pantorc. 40 mg Powder for solution intravenous use 40 mg Via Temolo 4 for injection 20126 Milan Italy

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Italy Recordati Industria Chimica e Peptazol 40 mg Gastro-resistant oral use Farmaceutica S.p.A tablet Via M. Civitali 1 20148 Milan Italy

Italy Recordati Industria Chimica e Peptazol 20 mg Gastro-resistant oral use Farmaceutica S.p.A tablet Via M. Civitali 1 20148 Milan Italy

Latvia Nycomed GmbH Controloc 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany

Latvia Nycomed GmbH Controloc 40 mg 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Lithuania Nycomed GmbH Controloc 20 mg Gastro-resistantoral use Byk-Gulden-Str.2 tablet 78467 Konstanz Germany Lithuania Nycomed GmbH Controloc 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Konstanz Germany

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Luxembourg Nycomed Belgium SCA/CVA Panto-Byk-20 20 mg Gastro-resistant oral use Gentsesteenweg 615 tablet 1080 Brussels Belgium

Luxembourg Nycomed Belgium SCA/CVA Panto-Byk-40 40 mg Gastro-resistant oral use Gentsesteenweg 615 tablet 1080 Brussels Belgium

Luxembourg Nycomed Belgium Panto-Byk-IV 40 mg Powder for solution intravenous use 40 mg SCA/CVA for injection Gentsesteenweg 615 1080 Brussels Belgium Luxembourg Nycomed Belgium SCA/CVA Pantozol-20 20 mg Gastro-resistant oral use Gentsesteenweg 615 tablet 1080 Brussels Belgium Luxembourg Nycomed Belgium SCA/CVA Pantozol 40 40 mg Gastro-resistant oral use Gentsesteenweg 615 tablet 1080 Brussels Belgium Luxembourg Nycomed Belgium SCA/CVA Pantozol-IV 40 mg Powder for solution intravenous use 40 mg Gentsesteenweg 615 for injection 1080 Brussels Belgium

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Netherlands Nycomed bv Pantozol 20 20 mg Gastro-resistant oral use Jupiterstraat 250 tablet 2132 HK Hoofddorp Netherlands Netherlands Nycomed bv Pantozol 40 40 mg Gastro-resistant oral use Jupiterstraat 250 tablet 2132 HK Hoofddorp Netherlands Netherlands Nycomed bv Pantozol i.v. 40 mg Powder for solution intravenous use 40 mg Jupiterstraat 250 for injection 2132 HK Hoofddorp Netherlands Netherlands Nycomed bv Pantoprazol Nycomed 40 mg 40 mg Gastro-resistant oral use Jupiterstraat 250 tablet 2132 HK Hoofddorp Netherlands Norway Nycomed GmbH Somac 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Norway Nycomed GmbH Somac 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Norway Nycomed GmbH Somac 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 for injection 78467 Constance Germany

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Poland Nycomed Pharma Sp.z o.o. Controloc 20 20 mg Gastro-resistant oral use Al. Jerozolimskie 146A tablet 02-305 Warsaw Poland Poland Nycomed Pharma Sp.z o.o. Controloc 40 40 mg Gastro-resistant oral use Al. Jerozolimskie 146A tablet 02-305 Warsaw Poland Poland Nycomed Pharma Sp.z o.o. Controloc 40 mg Powder for solution intravenous use 40 mg Al. Jerozolimskie 146A for injection 02-305 Warsaw Poland

Portugal Laboratórios Delta, Lda. Apton 40 mg 40 mg Gastro-resistant oral use Rua Direita, 148 tablet Massamá 2745-751 QUELUZ Portugal Portugal Laboratórios Delta, Lda. Apton 20 mg Gastro-resistant oral use Rua Direita, 148 tablet Massamá 2745-751 QUELUZ Portugal

Portugal Nycomed Portugal Pantoc 40 mg 40 mg Gastro-resistant oral use Produtos Farmaceuticos, Lda. tablet Quinta da Fonte Edificio Gil Eanes Paço D´Arcos 2770-192 Paço D` Arcos Portugal

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Portugal Nycomed Portugal - Produtos Pantoc 20 mg Gastro-resistant oral use Farmacêuticos, Lda. tablet Quinta da Fonte Edificio Gil Eanes Paço DÁrcos 2770-192 Paço D` Arcos Portugal Portugal Nycomed Portugal - Produtos Pantoc IV 40 mg Powder for solution intravenous use 40 mg Farmacêuticos, Lda. for injection Quinta da Fonte Edificio Gil Eanes Paço DÁrcos 2770-192 Paço D` Arcos Portugal Portugal Nycomed Portugal - Produtos Zurcal 20 mg Gastro-resistant oral use Farmacêuticos, Lda. tablet Quinta da Fonte Edificio Gil Eanes Paço DÁrcos 2770-192 Paço D` Arcos Portugal Portugal Nycomed Portugal Zurcal 40 mg 40 mg Gastro-resistant oral use Produtos Farmaceuticos, Lda. tablet Quinta da Fonte Edificio Gil Eanes Paço DÁrcos 2770-192 Paço D` Arcos Portugal Portugal Nycomed Portugal - Produtos Pantoprazole ALTANA 20 20 mg Gastro-resistant oral use Farmacêuticos, Lda. mg tablet Quinta da Fonte Edificio Gil Eanes Paço DÁrcos 2770-192 Paço D` Arcos Portugal

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Portugal Nycomed Portugal - Produtos Pantoprazole ALTANA 40 40 mg Gastro-resistant oral use Farmacêuticos, Lda. mg tablet Quinta da Fonte Edificio Gil Eanes Paço D´Arcos 2770-192 Paço D` Arcos Portugal Romania Nycomed GmbH Controloc 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Konstanz Germany Romania Nycomed GmbH Controloc 40 mg 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Konstance Germany Romania Nycomed GmbH Controloc i.v. 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 for injection 78467 Konstance Germany Slovak Nycomed GmbH Controloc 20 mg 20 mg Gastro-resistant oral use Republic Byk-Gulden-Str.2 gastrorezistentné tablety tablet 78467 Constance Germany Slovak Nycomed GmbH Controloc 40 mg 40 mg Gastro-resistant oral use Republic Byk-Gulden-Str.2 tablet 78467 Constance Germany Slovak Nycomed GmbH Controloc i.v. 40 mg Powder for solution intravenous use 40 mg Republic Byk-Gulden-Str.2 for injection 78467 Constance Germany

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Slovenia Nycomed GmbH Controloc 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 gastrorezistentne tablete tablet 78467 Constance Germany Slovenia Nycomed GmbH Controloc 40 mg 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 gastrorezistentne tablete tablet 78467 Constance Germany Slovenia Nycomed GmbH Controloc 40 mg prašek za 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 raztopino za injiciranje for injection 78467 Constance Germany

Spain Nycomed GmbH Anagastra 20 mg Blister 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Spain Nycomed GmbH Anagastra 40 mg blister 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Spain Nycomed GmbH Anagastra 40 mg polvo para 40 mg Powder for solution intravenous use 40 mg Byk-Gulden-Str.2 solución inyectable I.V. for injection 78467 Constance Germany Spain Nycomed GmbH Pantecta 20 mg comprimidos 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 gastrorresistentes Blister tablet 78467 Constance Germany

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

Spain Nycomed GmbH Pantecta 40 mg Blister 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Constance Germany Spain Nycomed GmbH Ulcotenal 20 mg 20 mg Gastro-resistant oral use Byk-Gulden-Str.2 comprimidos tablet 78467 Constance gastrorresistentes Blister Germany Spain Nycomed GmbH Ulcotenal 40 mg Blister 40 mg Gastro-resistant oral use Byk-Gulden-Str.2 tablet 78467 Konstanz Germany

Sweden Nycomed AB Pantoloc 20 mg Gastro-resistant oral use Box 27264 tablet 102 53 Stockholm Sweden Sweden Nycomed AB Pantoloc 40 mg Gastro-resistant oral use Box 27264 tablet 102 53 Stockholm Sweden Sweden Nycomed AB Pantoloc 40 mg Powder for solution intravenous use 40 mg Box 27264 for injection 102 53 Stockholm Sweden

United Nycomed GmbH Protium 20 mg 20 mg Gastro-resistant oral use Kingdom Byk-Gulden-Str.2 tablet 78467 Konstance Germany

Member Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Route of Content State Form administration (concentration) EU/EEA

United Nycomed GmbH Protium 40 mg 40 mg Gastro-resistant oral use Kingdom Byk-Gulden-Str.2 tablet 78467 Konstance Germany United Nycomed GmbH Protium i.v. 40 mg Powder for solution intravenous use 40 mg Kingdom Byk-Gulden-Str.2 for injection 78467 Konstance Germany