Bilag I. Liste med navne, lægemiddelformer, styrker, administrationsveje, indehavere af markedsføringstilladelsen i medlemslandene

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1 Bilag I Liste med navne, lægemiddelformer, styrker, administrationsveje, indehavere af i medlemslandene 1

2 Østrig Belgien Belgien Belgien Bulgarien Bulgarien Cypern Cypern UCB Pharma GmbH Geiselbergstraße Wien Austria Actavis EAD 29 Atanas Dukov Str. Sofia 1407 Bulgaria Atarax 25 mg - Filmten Atarax 10 mg Filmovertrukket Atarax Atarax 100 mg Filmovertrukket Atarax Neurolax Atarax Atarax 2 mg/ml Syrup 2

3 Tjekkiet Danmark Danmark Danmark Finland Finland Arne Jacobs Allé 15 Arne Jacobs Allé 15 Arne Jacobs Allé 15 UCB Pharma Oy Finland Itsehallintokuja ESPOO Finland UCB Pharma Oy Finland Itsehallintokuja ESPOO Finland 420 Avenue Estienne d'orves Défense Ouest Colombes France Atarax Atarax 2 mg/ml Oral opløsning Atarax 10 mg Filmovertrukket Atarax ATARAX 2 mg/ml Syrup ATARAX ATARAX 100 mg, comprimé 100 mg Filmovertrukket 3

4 420 Avenue Estienne d'orves Défense Ouest Colombes France 420 Avenue Estienne d'orves Défense Ouest Colombes France 420 Avenue Estienne d'orves Défense Ouest Colombes France Laboratoire Renaudin Z A. Errobi Itxassou Cambo les Bains France Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box Nicosia Cyprus Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box Nicosia Cyprus ATARAX 100 mg/2 ml, solution injectable ATARAX 25 mg, comprimé 100 mg/2 ml Injektionsvæske, opløsning Intravenøs anvendelse ATARAX sirop 2 mg/ml Syrup HYDROXYZINE RENAUDIN 100 mg /2 ml, solution injectable HYDROLAX 25 mg, comprimé HYDROXYZINE INOPHARM 25 mg, comprimé 100 mg/2 ml Injektionsvæske, opløsning Intravenøs anvendelse 4

5 Tyskland Tyskland Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box Nicosia Cyprus Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box Nicosia Cyprus Arrow Generiques 26 Avenue Tony Garnier Lyon France UCB Pharma GmbH Alfred-Nobel-Str Monheim Germany UCB Pharma GmbH Alfred-Nobel-Str Monheim Germany Olvos Science AE Eleftherias , Kifisia UCB A.E. Ag. Dimitriou , Alimos, Athens RAXTA 25 mg, comprimé TADRO 25 mg, comprimé HYDROXYZINE ARROW 25 mg, comprimé AH 3 N Tabletten Atarax Tabletten EFIDAC 5% Gel Kutan anvendelse ATARAX 5

6 UCB A.E. Ag. Dimitriou , Alimos, Athens UCB A.E. Ag. Dimitriou , Alimos, Athens UCB A.E. Ag. Dimitriou , Alimos, Athens Uni-Pharma Kleon Tsetis Farmakeftika Ergastria ABEE 14 Km. Nat. Road Athens-Lamia 14564, K. Kifisia Uni-Pharma Kleon Tsetis Farmakeftika Ergastria ABEE 14 Km. Nat. Road Athens-Lamia 14564, K. Kifisia Uni-Pharma Kleon Tsetis Farmakeftika Ergastria ABEE 14 Km. Nat. Road Athens-Lamia 14564, K. Kifisia ATARAX 100 mg/2 ml ATARAX 10 mg/5 ml Injektionsvæske, opløsning Oral opløsning ATARAX 100 mg Filmovertrukket Hydroxyzin IREMOFAR Hydroxyzin IREMOFAR 10 mg/5 ml Oral opløsning Intramuskulær anvendelse Hydroxyzin IREMOFAR 5% Gel Kutan anvendelse 6

7 Ungarn Island Island Irland Irland Italien Italien UCB Magyarország Kft. Árpád fejedelem útja Budapest Hungary Arne Jacobs Allé 15 Arne Jacobs Allé 15 UCB Pharma Ireland Ltd United Drug House Magna Drive, Magna Business Park Citywest Road Dublin 24 Ireland UCB Pharma Ireland Ltd United Drug House Magna Drive, Magna Business Park Citywest Road Dublin 24 Ireland UCB Pharma S.p.a. Via Gadames Milano Italy UCB Pharma S.p.a. Via Gadames Milano Italy Atarax 25 mg filmta Atarax 2 mg/ml Oral opløsning Atarax Ucerax 10mg/5ml Syrup Ucerax 25mg Film-coated Tablets 2 mg/ml Syrup ATARAX 2 mg/ml Syrup ATARAX 7

8 Italien Luxembourg Luxembourg Luxembourg Malta Malta Malta Norge UCB Pharma S.p.a. Via Gadames Milano Italy Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom Arne Jacobs Allé 15 ATARAX 100 mg/2 ml Injektionsvæske, opløsning Intramuskulær anvendelse Atarax 10 mg Overtrukket Atarax 25 mg Overtrukket Atarax 100 mg Overtrukket Atarax 10mg s Atarax 25mg s Atarax Syrup 0.2% 10 mg Tablet 25 mg Tablet 2 mg/ml Syrup Hydroxyzin Atarax 10 mg Filmovertrukket 8

9 Norge Arne Jacobs Allé 15 Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/ Pabianice Poland Biogened S.A ul. Pojezierska Łódź Poland Chemiczno- Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea Kraków Poland Hydroxyzin Atarax Atarax 2 mg/ml Syrup Atarax 10 mg Filmovertrukket Atarax Aflofarm Biogened Espefa 2 mg/ml Syrup 1,6 mg/g Syrup 2 mg/ml Syrup 9

10 Chemiczno- Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea Kraków Poland Espefa Chemiczno- Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea Kraków Poland Espefa 10 mg Filmovertrukket Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater Warszawa Poland Teva 50 mg/ml Infusionsvæske, opløsning Intramuskulær anvendelse PharmaSwiss Ceska Republika s.r.o. Jankovcova 1569/2c Praha 7 PSC Holesovice Czech Republic VP 2 mg/ml Syrup PharmaSwiss Ceska Republika s.r.o. Jankovcova 1569/2c Praha 7 PSC Holesovice Czech Republic VP 10 mg Filmovertrukket 10

11 Portugal Portugal Slovakiet Spanien PharmaSwiss Ceska Republika s.r.o. Jankovcova 1569/2c Praha 7 PSC Holesovice Czech Republic UCB Pharma (Produtos Farmacêuticos), Lda. Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1 Fracção D, Quinta da Fonte Paço de Arcos Porgutal UCB Pharma (Produtos Farmacêuticos), Lda. Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1 Fracção D, Quinta da Fonte Paço de Arcos Porgutal UCB s.r.o Thámova Praha 8 Czech Republic UCB Pharma, S.A. Paseo de la Castellana 141 planta 15 Madrid Spain VP Atarax Hydroxyzin Atarax 2 mg/ml Syrup Hydroxyzin ATARAX ATARAX 25 mg COMPRIMIDOS 11

12 Spanien Spanien Sverige Sverige Sverige Holland Holland UCB Pharma, S.A. Paseo de la Castellana 141 planta 15 Madrid Spain DERMOGEN PHARMA, S.A. Aragoneses, Alcobendas (Madrid) Spain Arne Jacobs Allé 15 Arne Jacobs Allé 15 Arne Jacobs Allé 15 UCB Pharma B.V. Lage Mosten NK BREDA The Netherlands UCB Pharma B.V. Lage Mosten NK BREDA The Netherlands Propyphenazon Kodein fosfat ATARAX 2mg/ml JARABE DOLODENS GRAGEAS 2 mg/ml Syrup 15 mg 100 mg 10 mg Tablet Atarax 10 mg Filmovertrukket Atarax Atarax 2 mg/ml Oral opløsning Hydroxyzine-2 HCl 10 Hydroxyzine-2 HCl mg Filmovertrukket 12

13 Storbritannie n UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom Ucerax 10mg/5ml Syrup 2 mg/ml Oral opløsning Storbritannie n UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom Ucerax 25 mg film-coated s 25 mg Overtrukket Storbritannie n Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom Atarax 10mg film-coated s 10 mg Tablet Storbritannie n Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom Atarax 25mg film-coated s 25 mg Overtrukket 13