Anexo I Lista dos nomes, formas s, dosagens dos medicamentos, vias de e, dos titulares das Autorizações de Introdução no Mercado nos Estados-Membros 1
Áustria Bélgica Bélgica Bélgica Bulgária Bulgária Chipre Chipre República Checa UCB Pharma GmbH Geiselbergstraße 17-19 1110 Wien Austria Actavis EAD 29 Atanas Dukov Str. Sofia 1407 Bulgaria Atarax 25 mg - Filmtabletten Atarax 10 mg Comprimido Atarax Atarax 100 mg Comprimido Atarax Neurolax Atarax Atarax 2 mg/ml Xarope Atarax 2
Dinamarca Dinamarca Dinamarca Finlândia Finlândia UCB Pharma Oy Finland Itsehallintokuja 6 02600 ESPOO Finland UCB Pharma Oy Finland Itsehallintokuja 6 02600 ESPOO Finland 420 Avenue Estienne d'orves Défense Ouest 92700 Colombes France 420 Avenue Estienne d'orves Défense Ouest 92700 Colombes France 420 Avenue Estienne d'orves Défense Ouest 92700 Colombes France Atarax 2 mg/ml Solução oral Atarax 10 mg Comprimido Atarax ATARAX 2 mg/ml Xarope ATARAX ATARAX 100 mg, comprimé ATARAX 100 mg/2 ml, solution injectable ATARAX 25 mg, comprimé 100 mg Comprimido 100 mg/2 ml Solução injetável Via intravenosa 3
420 Avenue Estienne d'orves Défense Ouest 92700 Colombes France Laboratoire Renaudin Z A. Errobi Itxassou 64250 Cambo les Bains France Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box 24854 1304 Nicosia Cyprus Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box 24854 1304 Nicosia Cyprus Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box 24854 1304 Nicosia Cyprus Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box 24854 1304 Nicosia Cyprus ATARAX sirop 2 mg/ml Syrup HYDROXYZINE RENAUDIN 100 mg /2 ml, solution injectable HYDROLAX 25 mg, comprimé HYDROXYZINE INOPHARM 25 mg, comprimé RAXTA 25 mg, comprimé TADRO 25 mg, comprimé 100 mg/2 ml Solution for injection Via intravenosa 4
Alemanha Alemanha Arrow Generiques 26 Avenue Tony Garnier 69007 Lyon France UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germany UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germany Olvos Science AE Eleftherias 4 145 64, Kifisia UCB A.E. Ag. Dimitriou 63 17456, Alimos, Athens UCB A.E. Ag. Dimitriou 63 17456, Alimos, Athens UCB A.E. Ag. Dimitriou 63 17456, Alimos, Athens UCB A.E. Ag. Dimitriou 63 17456, Alimos, Athens HYDROXYZINE ARROW 25 mg, comprimé AH 3 N Tabletten Atarax Tabletten Hidroxizina EFIDAC 5% Gel Uso cutâneo Hidroxizina ATARAX Hidroxizina ATARAX 100 mg/2 ml Solução injetável Via intramuscular Hidroxizina ATARAX 10 mg/5 ml Solução oral Hidroxizina ATARAX 100 mg Comprimido 5
Hungria Islândia Islândia Irlanda 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 UCB Magyarország Kft. Árpád fejedelem útja 26-28 1023 Budapest Hungary UCB Pharma Ireland Ltd United Drug House Magna Drive, Magna Business Park Citywest Road Dublin 24 Ireland Hidroxizina IREMOFAR Hidroxizina IREMOFAR 10 mg/5 ml Solução oral Hidroxizina IREMOFAR 5% Gel Uso cutâneo Atarax 25 mg filmtabletta Atarax 2 mg/ml Solução oral Atarax Ucerax 10mg/5ml Syrup 2 mg/ml Xarope 6
Irlanda Itália Itália Itália Luxemburgo Luxemburgo Luxemburgo Malta UCB Pharma Ireland Ltd United Drug House Magna Drive, Magna Business Park Citywest Road Dublin 24 Ireland UCB Pharma S.p.a. Via Gadames 57 20151 Milano Italy UCB Pharma S.p.a. Via Gadames 57 20151 Milano Italy UCB Pharma S.p.a. Via Gadames 57 20151 Milano Italy Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom Ucerax 25mg Film-coated Tablets ATARAX 2 mg/ml Xarope ATARAX ATARAX 100 mg/2 ml Solução injetável Atarax 10 mg Comprimido revestido Atarax revestido Atarax 100 mg Comprimido revestido 7 Atarax 10mg tablets Via intramuscular 10 mg Comprimido
Malta Malta Noruega Noruega Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/151 95-200 Pabianice Poland Atarax 25mg tablets Atarax Syrup 0.2% 2 mg/ml Xarope Hidroxizina Atarax 10 mg Comprimido Hidroxizina Atarax Atarax 2 mg/ml Xarope Atarax 10 mg Comprimido Atarax Aflofarm 2 mg/ml Xarope 8
Biogened S.A ul. Pojezierska 99 91-342 Łódź Poland Biogened 1,6 mg/g Xarope Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea 208 30-133 Kraków Poland Espefa 2 mg/ml Xarope Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea 208 30-133 Kraków Poland Espefa Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea 208 30-133 Kraków Poland Espefa 10 mg Comprimido Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warszawa Poland Teva 50 mg/ml Solução injetável Via intramuscular PharmaSwiss Ceska Republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 PSC 170 00 Holesovice Czech Republic VP 2 mg/ml Xarope PharmaSwiss Ceska Republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 PSC 170 00 Holesovice Czech Republic VP 10 mg Comprimido 9
Portugal Portugal República Eslocava Espanha Espanha PharmaSwiss Ceska Republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 PSC 170 00 Holesovice Czech Republic UCB Pharma (Produtos Farmacêuticos), Lda. Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1 Fracção D, Quinta da Fonte 2770-229 Paço de Arcos Portugal UCB Pharma (Produtos Farmacêuticos), Lda. Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1 Fracção D, Quinta da Fonte 2770-229 Paço de Arcos Portugal UCB s.r.o Thámova 13 180 00 Praha 8 Czech Republic UCB Pharma, S.A. Paseo de la Castellana 141 planta 15 Madrid 28046 Spain UCB Pharma, S.A. Paseo de la Castellana 141 planta 15 Madrid 28046 Spain VP Hidroxizina Atarax Hidroxizina Atarax 2 mg/ml Xarope ATARAX ATARAX 25 mg COMPRIMIDOS ATARAX 2mg/ml JARABE 2 mg/ml Xarope 10
Espanha Suécia Suécia Suécia Países Baixos Países Baixos Reino Unido Reino Unido DERMOGEN PHARMA, S.A. Aragoneses, 15 28108 Alcobendas (Madrid) Spain UCB Pharma B.V. Lage Mosten 33 4822 NK BREDA The Netherlands UCB Pharma B.V. Lage Mosten 33 4822 NK BREDA The Netherlands UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom Propifenazona Codeína, fosfato DOLODENS GRAGEAS 15 mg 100 mg 10 mg Comprimido Atarax 10 mg Comprimido Atarax Atarax 2 mg/ml Solução oral Hydroxyzine hydrochloride Hydroxyzine-2 HCl 10 Hydroxyzine-2 HCl 25 Ucerax 10mg/5ml Syrup Ucerax 25 mg film-coated tablets 10 mg Comprimido 2 mg/ml Solução oral revestido 11
Reino Unido Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom Hydroxyzine hydrochloride Atarax 10mg film-coated tablets 10 mg Comprimido Reino Unido Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom Hydroxyzine hydrochloride Atarax 25mg film-coated tablets revestido 12