Form. Gastro-resistant. tablet. 40 mg Gastro-resistant tablet. tablet. tablet
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1 ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
2 Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse Vienna Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse Vienna Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse Vienna Nycomed GmbH St. Peter Strasse Linz Nycomed GmbH St. Peter Strasse Linz Nycomed GmbH St. Peter Strasse Linz Pantoloc 20 mg - Filmten Pantoloc - Filmten Pantoloc - Trockenstechampulle Zurcal 20 mg -Filmten 20 mg Zurcal -Filmten Zurcal -Trockenstechampulle Gastro-resistant Powder for solution Gastro-resistant Gastro-resistant Powder for solution 2
3 Nycomed SCA/CVA Pantozol Gastro-resistant Nycomed SCA/CVA Nycomed SCA/CVA Nycomed SCA/CVA Nycomed SCA/CVA Nycomed SCA/CVA Pantozol Pantozol IV Powder for solution Zurcale Gastro-resistant Zurcale 20 mg Zurcale IV Powder for solution 3
4 Bulgaria Controloc Bulgaria Cyprus Cyprus Cyprus Mundipharma Pharmaceuticals Ltd. Othellos str. 13 Dhali Industrial Zone 1685 Nicosia Cyprus Mundipharma Pharmaceuticals Ltd. Othellos str. 13 Dhali Industrial Zone 1685 Nicosia Cyprus Mundipharma Pharmaceuticals Ltd. Othellos str. 13 Dhali Industrial Zone 1685 Nicosia Cyprus Controloc Gastro-resistant Controloc Controloc Gastro-resistant Controloc i.v. Powder for solution 4
5 Czech Republic Czech Republic Konstanz Konstanz Controloc 20 mg Controloc Gastro-resistant Czech Republic Denmark Denmark Denmark Konstanz Nycomed Denmark ApS Langebjerg Roskilde Denmark Nycomed Denmark ApS Langebjerg Roskilde Denmark Nycomed Denmark ApS Langebjerg Roskilde Denmark Controloc i.v. Powder for solution for injection Pantoloc Pantoloc Gastro-resistant Pantoloc Powder for solution 5
6 Estonia Konstanz Controloc 20 mg Estonia Finland Finland Finland Konstanz Nycomed 13, rue Watt Paris Controloc Gastro-resistant Somac 20 mg enteroti Somac enteroti Gastro-resistant Somac injektiokuivaaine, liuosta varten Eupantol 20 mg, comprimé gastrorésistant Powder for solution Nycomed 13, rue Watt Paris Eupantol, comprimé gastrorésistant Gastro-resistant 6
7 Nycomed 13, rue Watt Paris Nycomed 13, rue Watt Paris Nycomed 13, rue Watt Paris Nycomed 13, rue Watt Paris Nycomed 13, rue Watt Paris Nycomed 13, rue Watt Paris Eupantol poudre pour solution injectable IV Inipomp 20 mg, comprimé gastrorésistant Inipomp, comprimé gastrorésistant Inipomp ; poudre pour IV Pantec 20 mg, comprimé gastrorésistant Pantec, comprimé gastrorésistant Powder for solution Gastro-resistant Powder for solution Gastro-resistant Nycomed 13, rue Watt Paris Pantipp 20 mg, comprimé gastrorésistant 7
8 Nycomed 13, rue Watt Paris Pantipp, comprimé gastrorésistant Gastro-resistant Pantoprazol NYC 20 mg Pantoprazol NYC Gastro-resistant Pantoloc i.v. Powder for solution Pantoprazol 20 mg Byk Pantoprazol-Byk i.v. Powder for solution Pantozol 20 mg 8
9 Pantozol Gastro-resistant Pantozol i.v. Powder for solution PantoLomberg 20 mg Pantoprazole Lomberg 20 mg 20 mg Gastro-resistant Rifun 20 mg Byk Tosse Arzneimittel GmbH, Moltkestr. 4 Rifun Gastro-resistant Zurcal S 20 mg magensaftresistente Tabletten 9
10 Byk Tosse Arzneimittel GmbH, Moltkestr. 4 Sanofi-Aventis 348, Syngrou Avenue Building A Kallithea Sanofi-Aventis 348, Syngrou Avenue Building A Kallithea Sanofi-Aventis 348, Syngrou Avenue Building A Kallithea Nycomed Hellas S.A. 196, Kifissias Ave Chalandri Athens Nycomed Hellas S.A. 196, Kifissias Ave Chalandri Athens Zurcal S Gastro-resistant magensaftresistente Tabletten Controloc 20 mg Controloc Gastro-resistant Controloc i.v. Powder for solution Zurcazol 20 mg Zurcazol Gastro-resistant 10
11 Hungary Nycomed Hellas S.A. 196, Kifissias Ave Chalandri Athens Konstanz Zurcazol i.v. Powder for solution Controloc 20 mg Hungary Hungary Ireland Ireland Ireland Controloc Gastro-resistant Controloc i.v. Powder for solution Protium Gastro-resistant Protium 20 mg Protium i.v. Powder for solution 11
12 Nycomed Italia S.r.l via Libero Temolo Milan Pantecta Gastro-resistant Nycomed Italia S.r.l via Libero Temolo Milan Almirall S.p.A via Messina, 38 Torre C Milan Almirall S.p.A via Messina, 38 Torre C Milan Pantecta Pantopan Gastro-resistant Pantopan Nycomed S.p.A. Via Temolo Milan Nycomed S.p.A. Via Temolo Milan Nycomed S.p.A. Via Temolo Milan Pantorc Gastro-resistant Pantorc Pantorc. Powder for solution 12
13 Recordati Industria Chimica e Farmaceutica S.p.A Via M. Civitali Milan Peptazol Gastro-resistant Recordati Industria Chimica e Farmaceutica S.p.A Via M. Civitali Milan Peptazol Latvia Controloc 20 mg Latvia Controloc Gastro-resistant Lithuania Lithuania Konstanz Konstanz Controloc Controloc Gastro-resistant 13
14 Luxembourg Nycomed SCA/CVA Panto-Byk-20 Luxembourg Nycomed SCA/CVA Panto-Byk-40 Gastro-resistant Luxembourg Nycomed SCA/CVA Luxembourg Nycomed SCA/CVA Luxembourg Nycomed SCA/CVA Luxembourg Nycomed SCA/CVA Panto-Byk-IV Powder for solution Pantozol-20 Pantozol 40 Gastro-resistant Pantozol-IV Powder for solution 14
15 Netherlands Nycomed bv Jupiterstraat HK Hoofddorp Netherlands Netherlands Nycomed bv Jupiterstraat HK Hoofddorp Netherlands Netherlands Nycomed bv Jupiterstraat HK Hoofddorp Netherlands Netherlands Nycomed bv Jupiterstraat HK Hoofddorp Netherlands Norway Norway Norway Pantozol 20 Pantozol 40 Gastro-resistant Pantozol i.v. Powder for solution Pantoprazol Nycomed Gastro-resistant Somac Somac Gastro-resistant Somac Powder for solution 15
16 Poland Nycomed Pharma Sp.z o.o. Al. Jerozolimskie 146A Warsaw Poland Poland Nycomed Pharma Sp.z o.o. Al. Jerozolimskie 146A Warsaw Poland Poland Nycomed Pharma Sp.z o.o. Al. Jerozolimskie 146A Warsaw Poland Controloc 20 Controloc 40 Gastro-resistant Controloc Powder for solution Laboratórios Delta, Lda. Rua Direita, 148 Massamá QUELUZ Laboratórios Delta, Lda. Rua Direita, 148 Massamá QUELUZ Apton Gastro-resistant Apton Nycomed Produtos Farmaceuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D Arcos Paço D` Arcos Pantoc Gastro-resistant 16
17 Nycomed - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D Arcos Paço D` Arcos Nycomed - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D Arcos Paço D` Arcos Nycomed - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D Arcos Paço D` Arcos Nycomed Produtos Farmaceuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D Arcos Paço D` Arcos Nycomed - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D Arcos Paço D` Arcos Pantoc Pantoc IV Powder for solution Zurcal Zurcal Gastro-resistant Pantoprazole ALTANA 20 mg 17
18 Romania Romania Romania Slovak Republic Slovak Republic Slovak Republic Nycomed - Produtos Farmacêuticos, Lda. Quinta da Fonte Edificio Gil Eanes Paço D Arcos Paço D` Arcos Konstanz Konstance Konstance Pantoprazole ALTANA 40 mg Gastro-resistant Controloc 20 mg Controloc Gastro-resistant Controloc i.v. Powder for solution Controloc 20 mg gastrorezistentné y Controloc Gastro-resistant Controloc i.v. Powder for solution 18
19 Slovenia Slovenia Slovenia Controloc 20 mg gastrorezistentne e Controloc gastrorezistentne e Controloc prašek za raztopino za injiciranje Gastro-resistant Powder for solution Spain Spain Spain Spain Anagastra 20 mg Blister Anagastra blister Gastro-resistant Anagastra polvo para solución inyectable I.V. Pantecta 20 mg comprimidos gastrorresistentes Blister Powder for solution 19
20 Spain Spain Spain Konstanz Pantecta Blister Gastro-resistant Ulcotenal 20 mg comprimidos gastrorresistentes Blister Ulcotenal Blister Gastro-resistant Sweden Sweden Sweden Nycomed AB Box Stockholm Sweden Nycomed AB Box Stockholm Sweden Nycomed AB Box Stockholm Sweden Pantoloc Pantoloc Gastro-resistant Pantoloc Powder for solution United Kingdom Konstance Protium 20 mg 20
21 United Kingdom United Kingdom Konstance Konstance Protium Gastro-resistant Protium i.v. Powder for solution 21
Name. Priligy 30 mg Filmtabletten. Priligy 60 mg Filmtabletten. Priligy 30 mg filmomhulde tablet. Priligy 60 mg filmomhulde tablet
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1 Austria Janssen-Cilag Pharma
Product name Strength Pharmaceutical form. 100/6 micrograms per actuation. Formodual 100/6 Mikrogramm/Sprüh stoß, Druckgasinhalation, Lösung
Annex I List of the names, pharmaceutical, strength of the medicinal products, route of, marketing authorisation holders in the member states 1 Belgium Bulgaria Cyprus Denmark Estonia Finland 100/6 Mikrogramm/Sprüh
Route of administration. (Invented) Name Strength Pharmaceutical form. Applicant. Marketing authorisation holder. Member State EU/EEA
Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, applicants / marketing authorisation holders in the Member States 1 Belgium Belgium Belgium Cyprus GmbH Cyprus
1 mg Filmom obalená tableta. Kytril 1 mg / ml Injekčný/infúzny roztok. Kytril 2 mg Filmom obalená tableta. Kytril 2 mg 2 mg Filmom obalená tableta
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Annex I. Article 31 of Directive 2001/83/EC. Procedure number: EMEA/H/A-31/1448
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