1330 March 2015 EMA/123695/2004 rev.12 # Scientific & Regulatory Management EN Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland BG ｧ ｧﾓｧ罘荅筴ﾚｧ ｧ ｧﾖｧﾝｧﾔｧﾚｧ ｧ ｧｧﾝｧﾔｧﾑｧ筴ﾚｧ ｧｷｧｧ筴ﾓｧﾑｧ荅ﾚｧ ｧｬｧﾚｧ皎ｧ ｧｹｧﾖｧﾜｧﾑ ｧ筴ﾖｧ皎蟋ﾒｧﾝｧﾚｧﾜｧﾑ ｧ ｧﾑｧﾟｧﾚｧ ｧｦｧ罘荅爰ﾟｧﾚｧ ｧｶｧﾚｧﾟｧﾝｧﾑｧﾟｧﾕｧﾚｧ CS Rakousko Belgie Bulharsko Chorvatsko Kypr 09eskｨ republika Dｨ nsko Estonsko Finsko DA 01strig Belgien Bulgarien Kroatien Cypern Den Tjekkiske republik Danmark Estland Finland DE 00sterreich Belgien Bulgarien Kroatien Zypern Tschechische Republik D01nemark Estland Finnland EL ｦ ｦﾔｦﾒｦﾓｦﾑ0ﾋ7ｦﾁ ｦ 0ﾋ5ｦﾋｦﾃｦﾉｦﾏ ｦ ｦﾏｦﾔｦﾋｦﾃｦﾁｦﾑ0ﾋ7ｦﾁ ｦｪｦﾑｦﾏｦﾁｦﾓ0ﾋ7ｦﾁ ｦｪ0ﾌ3ｦﾐｦﾑｦﾏ0ﾋ9 ｦｳｦﾒｦﾅｦﾖｦﾉｦﾊ0ﾋ6 6ﾒ2ｦﾇｦﾌｦﾏｦﾊｦﾑｦﾁｦﾓ0ﾋ7ｦﾁ 6ﾒ2ｦﾁｦﾍ0ﾋ7ｦﾁ ｦ ｦﾒｦﾈｦﾏｦﾍ0ﾋ7ｦﾁ ｦｵｦﾉｦﾍｦﾋｦﾁｦﾍｦﾄ0ﾋ7ｦﾁ ES Austria Bｨｦlgica Bulgaria Croacia Chipre Repｨｲblica Checa Dinamarca Estonia Finlandia ET Austria Belgia Bulgaaria Horvaatia Kｨｹpros T08ehhi Taani Eesti Soome FI It01valta Belgia Bulgaria Kroatia Kypros Tshekki Tanska Viro Suomi FR Autriche Belgique Bulgarie Croatie Chypre Rｨｦpublique Tchｨｨque Danemark Estonie Finlande HR Austrija Belgija Bugarska Hrvatska Cipar 09e08ka Republika Danska Estonija Finska HU Ausztria Belgium Bulgｨ ria Horvｨ torszｨ g Ciprus Csehorszｨ g Dｨ nia 07sztorszｨ g Finnorszｨ g IS Austurrｨｪki Belgｨｪa Bｨｲlgarｨｪa Krｨｮatｨｪa K05pur Tｨｦkkland Danm02rk Eistland Finnland IT Austria Belgio Bulgaria Croazia Cipro Repubblica Ceca Danimarca Estonia Finlandia # Changes since the last revision: Inclusion of translations for Liechtenstein and minor changes in some languages 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union 08 European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
13EN Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland LT Austrija Belgija Bulgarija Kroatija Kipras 09ekija Danija Estija Suomija LV Austrija Be0400ija Bulgｨ rija Horvｨ tija Kipra 09ehija Dｨ nija Igaunija Somija MT L-Awstrija Il-Bel08ju Il-Bulgarija Il-Kroazja 07ipru Ir-Repubblika 07eka Id-Danimarka L-Estonja Il-Finlandja NL Oostenrijk Belgi05 Bulgarije Kroati05 Cyprus Tsjechi05 Denemarken Estland Finland NO 01sterrike Belgia Bulgaria Kroatia Kypros Tsjekkia Danmark Estland Finland PL Austria Belgia Bu00garia Chorwacja Cypr Czechy Dania Estonia Finlandia PT 09ustria Bｨｦlgica Bulgｨ ria Croｨ cia Chipre Repｨｲblica Checa Dinamarca Estｨｮnia Finl09ndia RO Austria Belgia Bulgaria Republica Croa00ia Cipru Republica Ceh00 Danemarca Estonia Finlanda SK Rakｨｲsko Belgicko Bulharsko Chorvｨ tsko Cyprus 09eskｨ republika Dｨ nsko Estｨｮnsko Fｨｪnsko SL Avstrija Belgija Bolgarija Hrva08ka Ciper 09e08ka Danska Estonija Finska SV 00sterrike Belgien Bulgarien Kroatien Cypern Tjeckien Danmark Estland Finland EN France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein BG ｧｶｧ筴ﾑｧﾟｧ隗ﾚｧ ｧ ｧﾖｧ筴ﾞｧﾑｧﾟｧﾚｧ ｧ ｧｧ筴隗ﾚｧ ｧｵｧﾟｧﾔｧﾑｧ筴ﾚｧ ｧｪｧ罘ﾝｧﾑｧﾟｧﾕｧﾚｧ ｧｪｧ筴ﾝｧﾑｧﾟｧﾕｧﾚｧ ｧｪｧ荅ﾑｧﾝｧﾚｧ ｧｭｧﾑｧ荅ﾓｧﾚｧ ｧｭｧﾚｧ遘荅ﾖｧﾟｧｧﾑｧﾛｧﾟ CZ Francie Nｨｧmecko 09ecko Ma02arsko Island Irsko Itｨ lie Loty08sko Lichten08tejnsko DA Frankrig Tyskland Gr03kenland Ungarn Island Irland Italien Letland Liechtenstein DE Frankreich Deutschland Griechenland Ungarn Island Irland Italien Lettland Liechtenstein EL ｦ ｦﾁｦﾋｦﾋ0ﾋ7ｦﾁ ｦ ｦﾅｦﾑｦﾌｦﾁｦﾍ0ﾋ7ｦﾁ ｦ ｦﾋｦﾋ0ﾋ4ｦﾄｦﾁ ｦｯｦﾔｦﾃｦﾃｦﾁｦﾑ0ﾋ7ｦﾁ ｦｩｦﾒｦﾋｦﾁｦﾍｦﾄ0ﾋ7ｦﾁ ｦｩｦﾑｦﾋｦﾁｦﾍｦﾄ0ﾋ7ｦﾁ ｦｩｦﾓｦﾁｦﾋ0ﾋ7ｦﾁ ｦｫｦﾅｦﾓｦﾏｦﾍ0ﾋ7ｦﾁ ｦｫｦﾉｦﾖｦﾓｦﾅｦﾍｦﾒｦﾓ0ﾋ4ｦﾉｦﾍ ES Francia Alemania Grecia Hungrｨｪa Islandia Irlanda Italia Letonia Liechtenstein ET Prantsusmaa Saksamaa Kreeka Ungari Island Iirimaa Itaalia L01ti Liechtenstein FI Ranska Saksa Kreikka Unkari Islanti Irlanti Italia Latvia Liechtenstein FR France Allemagne Grｨｨce Hongrie Islande Irlande Italie Lettonie Liechtenstein HR Francuska Njema00ka Gr00ka Ma04arska Island Irska Italija Latvija Lihten08tajn HU Franciaorszｨ g Nｨｦmetorszｨ g G02r02gorszｨ g Magyarorszｨ g Izland 01rorszｨ g Olaszorszｨ g Lettorszｨ g Liechtenstein IS Frakkland 0705skaland Grikkland Ungverjaland 01sland 01rland 01talｨｪa Lettland Liechtenstein EMA/123695/2004 Page 2/5
13EN France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein IT Francia Germania Grecia Ungheria Islanda Irlanda Italia Lettonia Liechtenstein LT Prancｨｱzija Vokietija Graikija Vengrija Islandija Airija Italija Latvija Lichten08teinas LV Francija Vｨ cija Grie09ija Ungｨ rija Islande/ 07rija Itｨ lija Latvija Lihten08teina 07slande MT Franza Il-07ermanja Il-Gre08ja L-Ungerija L-Islanda L-Irlanda L-Italja Il-Latvja Il-Liechtenstein NL Frankrijk Duitsland Griekenland Hongarije IJsland Ierland Itali05 Letland Liechtenstein NO Frankrike Tyskland Hellas Ungarn Island Irland Italia Latvia Liechtenstein PL Francja Niemcy Grecja W01gry Islandia Irlandia W00ochy 09otwa Lichtenstein PT Fran04a Alemanha Grｨｦcia Hungria Isl09ndia Irlanda Itｨ lia Letｨｮnia Liechtenstein RO Fran00a Germania Grecia Ungaria Islanda Irlanda Italia Letonia Liechtenstein SK Francｨｲzsko Nemecko Grｨｦcko Ma02arsko Island 01rsko Taliansko Loty08sko Lichten08tajnsko SL Francija Nem00ija Gr00ija Mad06arska Islandija Irska Italija Latvija Lihten08tajn SV Frankrike Tyskland Grekland Ungern Island Irland Italien Lettland Liechtenstein EN Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania BG ｧｭｧﾚｧ荅ﾓｧﾑ ｧｭｧｧﾜｧ罘ﾖｧﾞｧﾒｧ蟋筴ﾔ ｧｮｧﾑｧﾝｧ荅ﾑ ｧｯｧﾚｧﾕｧﾖｧ筴ﾝｧﾑｧﾟｧﾕｧﾚｧ ｧｯｧ爰筴ﾓｧﾖｧﾔｧﾚｧ ｧｱｧ爰ﾝｧﾑ ｧｱｧ爰筴荅蟋ﾔｧﾑｧﾝｧﾚｧ ｧｲｧ蟋ﾞｧｧﾟｧﾚｧ CS Litva Lucembursko Malta Nizozemsko Norsko Polsko Portugalsko Rumunsko DA Litauen Luxembourg Malta Nederlandene 2 (Holland*) Norge Polen Portugal Rum03nien DE Litauen Luxemburg Malta Niederlande Norwegen Polen Portugal Rum01nien EL ｦｫｦﾉｦﾈｦﾏｦﾔｦﾁｦﾍ0ﾋ7ｦﾁ ｦｫｦﾏｦﾔｦﾎｦﾅｦﾌｦﾂｦﾏ0ﾌ3ｦﾑｦﾃｦﾏ ｦｬ0ﾋ4ｦﾋｦﾓｦﾁ ｦｪ0ﾋ4ｦﾓｦﾘ ｦｶ0ﾌ4ｦﾑｦﾅ0ﾋ9 1 (ｦｯｦﾋｦﾋｦﾁｦﾍｦﾄ0ﾋ7ｦﾁ*) ｦｭｦﾏｦﾑｦﾂｦﾇｦﾃ0ﾋ7ｦﾁ ｦｰｦﾏｦﾋｦﾘｦﾍ0ﾋ7ｦﾁ ｦｰｦﾏｦﾑｦﾓｦﾏｦﾃｦﾁｦﾋ0ﾋ7ｦﾁ ｦｱｦﾏｦﾔｦﾌｦﾁｦﾍ0ﾋ7ｦﾁ ES Lituania Luxemburgo Malta Paｨｪses Bajos Noruega Polonia Portugal Rumanｨｪa ET Leedu Luksemburg Malta Holland Norra Poola Portugal Rumeenia FI Liettua Luxemburg Malta Alankomaat Norja Puola Portugali Romania FR Lituanie Luxembourg Malte Pays-Bas Norvｨｨge Pologne Portugal Roumanie HR Litva Luksemburg Malta Nizozemska Norve08ka Poljska Portugal Rumunjska HU Litvｨ nia Luxemburg Mｨ lta Hollandia Norvｨｦgia Lengyelorszｨ g Portugｨ lia Romｨ nia EMA/123695/2004 Page 3/5
13EN Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania IS Lithｨ en Lｨｲxemborg Malta Ni08url02nd 2 (Holland*) Noregur Pｨｮlland Portｨｲgal Rｨｲmenｨｪa IT Lituania Lussemburgo Malta Paesi Bassi Norvegia Polonia Portogallo Romania LT Lietuva Liuksemburgas Malta Olandija (Nyderlandai*) Norvegija Lenkija Portugalija Rumunija LV Lietuva Luksemburga Malta Nｨｩderlande Norvｨ 00ija Polija Portugｨ le Rumｨ nija MT Il-Litwanja Il-Lussemburgu Malta L-Olanda In-Norve08ja Il-Polonja Il-Portugall Ir-Rumanija NL Litouwen Luxemburg Malta Nederland Noorwegen Polen Portugal Roemeni05 NO Litauen Luxemburg Malta Nederland Norge 4 Polen Portugal Romania PL Litwa Luksemburg Malta Holandia Norwegia Polska Portugalia Rumunia PT Litu09nia Luxemburgo Malta Paｨｪses Baixos Noruega Polｨｮnia Portugal Romｨｦnia RO Lituania Luxemburg Malta Olanda Norvegia Polonia Portugalia Rom09nia SK Litva Luxembursko Malta Holandsko Nｨｮrsko Po06sko Portugalsko Rumunsko SL Litva Luksemburg Malta Nizozemska Norve08ka Poljska Portugalska Romunija SV Litauen Luxemburg Malta Nederl01nderna Norge Polen Portugal Rum01nien EN Slovak Republic Slovenia Spain Sweden United Kingdom BG ｧｳｧﾝｧ爰ﾓｧﾑｧﾜｧﾚｧ ｧｳｧﾝｧ爰ﾓｧﾖｧﾟｧﾚｧ ｧｪｧ罘皎ﾑｧﾟｧﾚｧ ｧｺｧﾓｧﾖｧ隗ﾚｧ ｧ ｧﾖｧﾝｧﾚｧﾜｧ爰ﾒｧ筴ﾚｧ荅ﾑｧﾟｧﾚｧ (ｧｰｧﾒｧﾖｧﾕｧﾚｧﾟｧﾖｧﾟｧ ｧﾜｧ筴ﾑｧﾝｧ罘荅ﾓｧ) CS Slovenskｨ republika Slovinsko 07panｨｧlsko 07vｨｦdsko Spojenｨｦ krｨ lovstvｨｪ (Velkｨ Britｨ nie*) DA Slovakiet Slovenien Spanien Sverige Det Forenede Kongerige 3 (Storbritannien*) DE Slowakei Slowenien Spanien Schweden Vereinigtes K02nigreich EL ｦｲｦﾋｦﾏｦﾂｦﾁｦﾊ0ﾋ7ｦﾁ ｦｲｦﾋｦﾏｦﾂｦﾅｦﾍ0ﾋ7ｦﾁ ｦｩｦﾒｦﾐｦﾁｦﾍ0ﾋ7ｦﾁ ｦｲｦﾏｦﾔｦﾇｦﾄ0ﾋ7ｦﾁ ｦｧｦﾍｦﾘｦﾌ0ﾋ5ｦﾍｦﾏ ｦ ｦﾁｦﾒ0ﾋ7ｦﾋｦﾅｦﾉｦﾏ ES Eslovaquia Eslovenia Espa09a Suecia Reino Unido ET Slovakkia Sloveenia Hispaania Rootsi 05hendkuningriik FI Slovakia Slovenia Espanja Ruotsi Yhdistynyt kuningaskunta (Iso-Britannia*) FR Slovaquie Slovｨｦnie Espagne Suｨｨde Royaume-Uni HU Szlovｨ kia Szlovｨｦnia Spanyolorszｨ g Svｨｦdorszｨ g Egyesｨｹlt Kirｨ lysｨ g HR Slova00ka Republika Slovenija 07panjolska 07vedska Ujedinjeno Kraljevstvo EMA/123695/2004 Page 4/5
13EN Slovak Republic Slovenia Spain Sweden United Kingdom IS Slｨｮvakｨｪa Slｨｮvenｨｪa Spｨ nn Svｨｪ06jｨｮ08 Sameina08a konungsd03mi08 3 (Bretland*) IT Slovacchia Slovenia Spagna Svezia Regno Unito LT Slovakija Slov09nija Ispanija 07vedija Did06ioji Britanija (Jungtin09 Karalyst09*) LV Slovｨ kija Slovｨ nija Spｨ nija Zviedrija Lielbritｨ nija MT Is-Slovakkja Slovenja Spanja L-Isvezja Ir-Renju Unit NL Slowakije Sloveni05 Spanje Zweden Verenigd Koninkrijk NO Slovakia Slovenia Spania Sverige Det forente kongerike 3 (Storbritannia*) PL S00owacja S00owenia Hiszpania Szwecja Wielka Brytania PT Eslovｨ quia Eslovｨｦnia Espanha Suｨｦcia Reino Unido RO Republica Slovac00 Slovenia Spania Suedia Marea Britanie SK Slovenskｨ republika Slovinsko 07panielsko 07vｨｦdsko Spojenｨｦ krｨ 06ovstvo (Ve06kｨ Britｨ nia*) SL Slova08ka Slovenija 07panija 07vedska Zdru06eno kraljestvo (Velika Britanija*) SV Slovakien Slovenien Spanien Sverige F02renade Kungariket 3 (Storbritannien*) (...*) Although they are not the official names for the Netherlands and the United Kingdom, these should be used in the SPC, labelling and package leaflet for the following reasons: 1 understood as being a region including Belgium, Luxembourg and the Netherlands 2 understood as being a region including Belgium and the Netherlands 3 not understood, general people may even think of this referring to a state of the Gulf, e.g. ｰUnited Emirates ｱ 4 Norway ｯs official languages are Bokm02l and Nynorsk (Norge/ Noreg), however since the product information is always written in Bokm02l, Norway accepted that only ｰNorge ｱ be used EMA/123695/2004 Page 5/5