FrancophonIA/ELRC3.0 huggingface dataset:
Italian: Lussemburgo eurogenerics SA esplanade heysel b22
Estonian: Luksemburg eurogenerics SA esplanade heysel b22
Italian: Regno Unito Wockhardt UK Limited Ash Road North
Estonian: Ühendkuningriik Wockhardt UK Limited Ash Road North
Italian: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Estonian: Parque Expo, Edificio Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Italian: Danimarca Alternova A/S Lodhusvej 11
Estonian: Alternova A/S Lodhusvej 11
Italian: M19 2RB Manchester United Kingdom
Estonian: M19 2RB Manchester
Italian: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B
Estonian: Quinta da Fonte, Rua Vitor Câmara, 2 - Edificio D. Amélia, Piso 1, Ala B
Italian: Regno Unito Bristol Laboratories Limited Unit 3, Canalside
Estonian: Ühendkuningriik Bristol Laboratories Limited Unit 3, Canalside
Italian: RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3
Estonian: Prantsusmaa RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3
Italian: Portogallo Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Estonian: Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16° Piso, Amoreiras
Italian: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris
Estonian: Prantsusmaa Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris
Italian: Portogallo Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Estonian: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Italian: Regno Unito Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
Estonian: Ühendkuningriik Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
Italian: Danimarca Janssen-Cilag (TIBOTEC) Hammerbakken 19
Estonian: Janssen-Cilag (TIBOTEC) Hammerbakken 19
Italian: Regno Unito Focus Pharmaceuticals Limited Unit 5, Faraday Court
Estonian: Ühendkuningriik Focus Pharmaceuticals Limited Unit 5, Faraday Court
Italian: DOMPERIDONE DR. REDDY'S
Estonian: Domperidone DOMPERIDONE DR. REDDY'S
Italian: Portogallo GP - Genéricos Portugueses, Lda.
Estonian: GP - Genéricos Portugueses, Lda.
Italian: ANGENERICO S.p.a. Via Nocera Umbra 75, 00181 Roma
Estonian: Via Nocera Umbra 75, 00181 Roma
Italian: Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenia
Estonian: Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenia domperidone Motilium
Italian: Portogallo Ciclum Farma Unipessoal, Lda.
Estonian: Ciclum Farma Unipessoal, Lda.
Italian: 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE
Estonian: Prantsusmaa ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE
Italian: 3062 CE Rotterdam The Netherlands
Estonian: 3062 CE Rotterdam
Italian: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France
Estonian: Prantsusmaa ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre
Italian: Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin Ireland
Estonian: Madalmaad Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin
Italian: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini
Estonian: Prantsusmaa SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini
Italian: Samenwerkende Apothekers Nederland B.V.
Estonian: Madalmaad Samenwerkende Apothekers Nederland B.V.
Italian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora
Estonian: Edificios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal domperidone Remotil
Italian: Regno Unito Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Estonian: Ühendkuningriik Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Italian: 150 00 Praha 5 - Smíchov Czech Republic
Estonian: 150 00 Praha 5 - Smichov Czech Republic domperidone Motilium
Italian: McNeil Healthcare (Ireland) Limited
Estonian: McNeil Healthcare (Ireland) Limited Airton Road
Italian: Regno Unito McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Estonian: Ühendkuningriik McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Italian: 3505 Limassol
Estonian: 3505 Limassol Cyprus
Italian: 1, rue Camille Desmoulins TSA 91003
Estonian: Prantsusmaa Janssen-Cilag 1, rue Camille Desmoulins TSA 91003
Italian: 2031 GA Haarlem The Netherlands
Estonian: 2031 GA Haarlem
Italian: Portogallo Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Estonian: Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Italian: Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9° CDE 1600-160 Lissabon Portugal
Estonian: Estrada da Luz, 90-9° CDE 1600-160 Lissabon
Italian: Portogallo Germed Farmacêutica, Lda.
Estonian: Germed Farmacêutica, Lda.
Italian: mg/100 ml sciroppo
Estonian: mg/100 ml siirup
Italian: Archimedesweg 2 2333 CN Leiden The Netherlands
Estonian: 2333 CN Leiden The Netherlands
Italian: ALMUS S.R.L. Via Cesarea 11/10 16121 Genova Italy
Estonian: Via Cesarea 11/10 16121 Genova Italy
Italian: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux
Estonian: Prantsusmaa Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton
Italian: Lussemburgo Johnson & Johnson Consumer N.V.
Estonian: Luksemburg Johnson & Johnson Consumer N.V.
Italian: Domperidona Gamir 10 mg cápsulas duras
Estonian: Domperidone Domperidona Gamir 10 mg cápsulas duras
Italian: Hamwells Business Park Unit No7, Hardicker Street
Estonian: Madalmaad Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No7, Hardicker Street
Italian: Portogallo Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Estonian: Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Italian: Regno Unito Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate Domperidone 10mg Tablets
Estonian: Ühendkuningriik Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
Italian: Regno Unito Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG,
Estonian: Ühendkuningriik Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Italian: JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
Estonian: JOHNSON & JOHNSON HEΛΛAƩ CONSUMER SA
Italian: Regno Unito Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate Domperidone 10mg Tablets
Estonian: Ühendkuningriik Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
Italian: DOMPERIDONE MYLAN GENERICS
Estonian: Domperidone DOMPERIDONE MYLAN GENERICS
Italian: TERAPIA S.A.
Estonian: S.C. TERAPIA S.A.
Italian: SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa - Milano Italy
Estonian: Via Firenze, 40 20060 Trezzano Rosa - Milano Italy
Italian: Portogallo ToLife - Produtos Farmacêuticos, S.A.
Estonian: ToLife - Produtos Farmacêuticos, S.A.
Italian: 20144 Milano
Estonian: 20144 Milano Italy
Italian: DOMPERIDONE DOC GENERICI
Estonian: Domperidone DOMPERIDONE DOC GENERICI
Italian: Samenwerkende Apothekers
Estonian: Apothekers
Italian: Motilium 30 mg supositorios niños
Estonian: Domperidone Motilium 30 mg supositorios niños
Italian: Baarnsche Dijk 1 3741 LN Baarn The Netherlands
Estonian: 3741 LN Baarn
Italian: B-2340, Beerse Belgium motilium 10mg film coated tablets
Estonian: B-2340, Beerse Belgium domperidone motilium 10mg film coated tablets
Italian: Motilium suspensie voor oraal gebruik 1 mg/ml
Estonian: Domperidone Motilium suspensie voor oraal gebruik 1 mg/ml
Italian: Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Estonian: Domperidone Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Italian: Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
Estonian: Madalmaad Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
Italian: MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus
Estonian: MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus domperidone COSTI TABLETS 10MG 10 mg tablett
Italian: Portogallo Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
Estonian: Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal domperidone Domperidona Labesfal 10 mg tablett
Italian: Greece
Estonian: Kreeka
Italian: Portogallo Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa
Estonian: Baldacci - Portugal, S.A. Rua Candido de Figueiredo, 84-B 1549-005 Lisboa Portugal domperidone Domperidona Baldacci 10 mg õhukese polümeerikattega tablett
Italian: Motilium-10 supp.
Estonian: Belgium domperidone Motilium-10 supp.
Italian: Hertogswetering 159 3543 AS Utrecht The Netherlands
Estonian: 3543 AS Utrecht
Italian: Veluwezoom 22 1327 AH Almere The Netherlands
Estonian: 1327 AH Almere The Netherlands
Italian: B-2340, Beerse Belgium motilium 1mg/ml oral suspension
Estonian: B-2340, Beerse Belgium domperidone motilium 1mg/ml oral suspension
Italian: 20 mg / 15 mg compressa
Estonian: 20 mg / 15 mg tablett
Italian: REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus
Estonian: REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus domperidone PEPTOMET FILM COATED TABLETS 10MG
Italian: Portogallo Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa
Estonian: Actavis A/S Sucursal Rua Virgilio Correia, 11 - A 1600-219 Lisboa Portugal domperidone Domperidona Actavis 10 mg tablett
Italian: AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France
Estonian: Prantsusmaa AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines
Italian: Regno Unito Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom
Estonian: Ühendkuningriik Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
Italian: B-2340, Beerse Belgium motilium 30 mg Suppositories
Estonian: B-2340, Beerse Belgium domperidone motilium 30 mg Suppositories
Italian: Nauzelin 10 mg comprimidos recubiertos con película
Estonian: Domperidone Nauzelin 10 mg comprimidos recubiertos con película
Italian: Domerid Relief 10mg Tablets.
Estonian: Domperidone Domerid Relief 10mg Tablets.
Italian: ROTTAPHARM, S.L. Avda.
Estonian: ROTTAPHARM, S.L.
Italian: Sandoz B.V.
Estonian: Madalmaad Sandoz B.V.
Italian: Rua Henrique Paiva Couceiro, 29Venda Nova 2700-451 Amadora Portugal
Estonian: Rua Henrique Paiva Couceiro, 29Venda Nova
Italian: PERIDON
Estonian: PERMOTIL
Italian: ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France
Estonian: Prantsusmaa ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France domperidone DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé
Italian: Regno Unito Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate Domperidone 10mg Tablets
Estonian: Ühendkuningriik Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD,
Italian: 5 mg/5 ml soluzione orale uso orale
Estonian: 5 mg/5 ml suukaudne lahus
Italian: 1-10 Constantinoupoleos St. P.O.
Estonian: Slovaki Vabariik Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
Italian: Motilium Domperidone Base
Estonian: Belgium domperidone Motilium Domperidone Base
Italian: Orosperidys 10 mg comprimidos bucodispersables
Estonian: Domperidone Orosperidys 10 mg comprimidos bucodispersables
Italian: Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2730-055 Barcarena Portugal
Estonian: Estrada Consiglieri Pedroso, 69 AQueluz de Baixo
Italian: Janssen-Cilag s.r.o.
Estonian: Tšehhi Vabariik Janssen-Cilag s.r.o.
Italian: TEVA ITALIA S.R.L. Via Messina 38 20154 Milano Italy
Estonian: Via Messina 38 20154 Milano Italy
Italian: Domperidonemaleat Domperidon - 1 A Pharma 10 mg Tabletten
Estonian: Domperidon - 1 A Pharma 10 mg Tabletten
Italian: CRISTERS 22 quai Gallieni 92150 Suresnes France
Estonian: Prantsusmaa CRISTERS 22 quai Gallieni 92150 Suresnes France domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Italian: Johnson & Johnson Consumer B.V.
Estonian: Madalmaad Johnson & Johnson Consumer B.V.
Italian: 20 mg/ 19 mg compressa
Estonian: 20 mg/ 19 mg tablett
Italian: Motilium zetpillen voor zuigelingen 10 mg
Estonian: Domperidone Motilium zetpillen voor zuigelingen 10 mg
Italian: DOMPERIDONE ARROW 1 mg/ml, suspension buvable
Estonian: France domperidone DOMPERIDONE ARROW 1 mg/ml, suspension buvable
Italian: Lussemburgo Pierre Fabre Médicament 45 place Abel Gance
Estonian: Luksemburg Pierre Fabre Médicament 45 place Abel Gance
Italian: Motilium Rx 10 mg Filmcoated Tablets.
Estonian: Domperidone Motilium Rx 10 mg Film-coated Tablets.
Italian: Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Estonian: Domperidone Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Italian: Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Estonian: Domperidone Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Italian: Motilium zetpillen voor volwassenen 60 mg
Estonian: Domperidone Motilium zetpillen voor volwassenen 60 mg
Italian: Domperidon 60 mg zetpillen
Estonian: Domperidone Domperidon 60 mg zetpillen
Italian: DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Estonian: domperidone DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Italian: Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Estonian: Domperidone Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Italian: Motilium 10 mg comprimidos recubiertos con película
Estonian: Domperidone Motilium 10 mg comprimidos recubiertos con película
Italian: Healthypharm B.V.
Estonian: Madalmaad Healthypharm B.V.
Italian: Regno Unito Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate Motilium 10mg Filmcoated Tablets
Estonian: Ühendkuningriik Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidone Domperidone 1mg/ml Oral Suspension
Italian: Mediq Farma B.V.
Estonian: Madalmaad Mediq Farma B.V.
Italian: Domperidon 30 mg zetpillen
Estonian: Domperidone Domperidon 30 mg zetpillen
Italian: Motilium Fastmelts 10mg Tablets
Estonian: Domperidone Motilium Fastmelts 10mg Tablets
Italian: Domperidona Gamir 1 mg/ml suspensión oral
Estonian: Domperidone Domperidona Gamir 1 mg/ml suspensión oral
Italian: PENSA PHARMA S.P.A. Via Ippolito Rossellini 12 20124 Milano Italy
Estonian: Via Ippolito Rossellini 12 20124 Milano Italy
Italian: 92517 Boulogne Billancourt Cedex France
Estonian: 92654 Boulogne Cedex France
Italian: QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France
Estonian: Prantsusmaa QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé
Italian: Leidapharm B.V.
Estonian: Madalmaad Leidapharm B.V.
Italian: Cinet
Estonian: Zilium
Italian: SUBSTIPHARM 8, rue Bellini 75116 Paris France
Estonian: Prantsusmaa SUBSTIPHARM 8, rue Bellini
Italian: 5 mg sospensione orale
Estonian: 5 mg suukaudne suspensioon suukaudne
Italian: Motilium-1mg/ml
Estonian: Belgium domperidone Motilium-1mg/ml
Italian: Motilium zetpillen voor kinderen 30 mg
Estonian: Domperidone Motilium zetpillen voor kinderen 30 mg
Italian: Motilium 60mg Suppositories
Estonian: Domperidone Motilium 60mg Suppositories
Italian: BIPERIDYSFLASH 20 mg, comprimé orodispersible
Estonian: France domperidone BIPERIDYSFLASH 20 mg, comprimé orodispersible
Italian: Costi
Estonian: Domperidone COSTI
Italian: Domperidonemaleat Domperidon-ratiopharm 10 mg Filmtabletten
Estonian: Domperidon ratiopharm 10 mg Filmtabletten
Italian: Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom domperidone maleate Domperidone 10mg Tablets
Estonian: Wrexham Industrial Estate Wrexham LL13 9UF
Italian: H-2045 Törökbálint Hungary
Estonian: H-2045 Törökbálint Hungary domperidone Motilium 10 mg filmtabletta
Italian: Marel B.V.
Estonian: Madalmaad Marel B.V.
Italian: Domperidonemaleat Domperidon AbZ 10 mg Filmtabletten
Estonian: Domperidon AbZ 10 mg Filmtabletten
Italian: Domperidon JJC zetpillen voor zuigelingen 10 mg
Estonian: Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg
Italian: 1 mg/ml sospensione orale
Estonian: 1 mg/ml suspensioon
Italian: Domperidon JJC filmomhulde tabletten 10 mg
Estonian: Domperidone Domperidon JJC filmomhulde tabletten 10 mg
Italian: Domperidon JJC zetpillen voor kinderen 30 mg
Estonian: Domperidone Domperidon JJC zetpillen voor kinderen 30 mg
Italian: Domperidon JJC zetpillen voor volwassenen 60 mg
Estonian: Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg
Italian: DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable
Estonian: France domperidone DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable
Italian: Domperidonemaleat Domperidon-CT 10 mg Filmtabletten
Estonian: Domperidon-CT 10 mg Filmtabletten
Italian: Motilium 30 mg Suppositories
Estonian: Domperidone Motilium 30 mg Suppositories
Italian: Domperidonemaleat Domidon 10 mg Filmtabletten
Estonian: Domidon 10 mg Filmtabletten
Italian: Centrafarm B.V.
Estonian: Madalmaad Centrafarm B.V.
Italian: 1 settembre 2014 EMA/465179/2014
Estonian: 1. september 2014 EMA/465179/2014
Italian: • I dati a sostegno di altre indicazioni erano estremamente limitati.
Estonian: • Muid näidustusi toetavad andmed olid väga piiratud.
Italian: Per contattare i nostri addetti stampa Monika Benstetter o Martin Harvey
Estonian: EMA pressiesindajad Monika Benstetter ja Martin Harvey
Italian: In generale, il riesame della sicurezza indica che il 40% circa di tali segnalazioni riguarda pazienti di età superiore ai 60 anni.
Estonian: Üldiselt osutavad ohutuse ülevaated, et umbes 40% sellistest teadetest käsitlevad vanemaid kui 60aastaseid patsiente.
Italian: Le prove dell'efficacia a disposizione non erano sufficienti ad avvalorarne l'uso per altre indicazioni.
Estonian: Olemasolevad tõendid efektiivsuse kohta ei olnud piisavad selle kasutamise toetamiseks muudel näidustustel.
Italian: Il riesame di domperidone è stato avviato in data 1 marzo 2013 su richiesta dell'autorità belga per i medicinali, l'Agenzia federale per i medicinali e i prodotti sanitari (FAGG-AFMPS), ai sensi dell'articolo 31 della direttiva 2001/83/CE.
Estonian: Domperidooni läbivaatamine algas 1. märtsil 2013 Belgia ravimiameti (ravimite ja tervisetoodete föderaalne amet FAGG-AFMPS) direktiivi 2001/83/EÜ artikli 31 kohase taotluse alusel.
Italian: Sebbene l'ambito del riesame non riguardasse l'uso al di fuori delle indicazioni autorizzate (uso offlabel), i principi alla base di queste raccomandazioni devono essere tenuti in considerazione ogniqualvolta si utilizzi domperidone.
Estonian: Kuigi läbivaatamine ei hõlmanud kasutamist väljaspool litsentsitud näidustusi (registreerimata näidustustel kasutamist), tuleks kõnealuste soovituste aluseks olevaid põhimõtteid arvestada alati, kui kasutatakse domperidooni.
Italian: Per affrontare il problema sono quindi state incluse nelle informazioni sul prodotto adeguate misure di minimizzazione del rischio.
Estonian: Seepärast lisati ravimiteabesse selle probleemi lahendamiseks asjakohased riski minimeerimise meetmed.
Italian: • Domperidone dev'essere utilizzato alla dose minima efficace per il più breve tempo possibile.
Estonian: • Domperidooni peab kasutama vähimas efektiivses annuses lühima võimaliku aja jooksul.
Italian: Ciò è in linea con i dati derivati da studi d'interazione tra farmaci e da segnalazioni spontanee.
Estonian: See on kooskõlas ravimite koostoime uuringutest pärinevate andmete ja spontaansete teadetega.
Italian: Limitazioni d'uso dei medicinali contenenti domperidone
Estonian: Domperidooni sisaldavate ravimite kasutamispiirangud
Italian: Alcuni medicinali saranno ritirati dal commercio perché il loro dosaggio non è conforme alle nuove dosi.
Estonian: Mõned ravimid võetakse turult tagasi, sest nende tugevus ei vasta uutele annustele.
Italian: La forma iniettabile di domperidone è stata ritirata nel 1985 a causa di tali effetti indesiderati.
Estonian: Domperidooni süstitav vorm võeti selliste kõrvalnähtude tõttu 1985. aastal tagasi.
Italian: Le raccomandazioni sono state inizialmente espresse dal comitato di valutazione dei rischi per la farmacovigilanza (PRAC) dell'EMA, in occasione della riunione del 3-6 marzo, dopo un'attenta valutazione delle prove disponibili sui benefici e sui rischi di tali medicinali.
Estonian: Soovitused andis algselt Euroopa Ravimiameti ravimiohutuse riskihindamiskomitee oma 3.-6. märtsi koosolekul pärast kõnealuste ravimitega seotud kasulikkuse ja riskide kohta olemasolevate tõendite hoolikat hindamist.
Italian: Vi erano dati limitati a sostegno dell'uso pediatrico in questa indicazione e, sebbene non ci si attenda un diverso meccanismo d'azione tra adulti e bambini, sono stati richiesti studi per fornire ulteriori dati intesi a confermarne l'efficacia nella popolazione pediatrica.
Estonian: Andmed olid piiratud, toetamaks pediaatrilist kasutamist sellel näidustusel, ning kuigi toimemehhanism eeldatavasti täiskasvanutel ja lastel ei erine, on taotletud uuringuid, et saada täiendavaid andmeid, mis kinnitaksid efektiivsust laste puhul.
Italian: La durata massima del trattamento non deve in genere superare una settimana.
Estonian: Ravi maksimaalne kestus ei tohiks üldjuhul ületada ühte nädalat.
Italian: • Per qualsiasi dubbio, i pazienti o il personale assistenziale devono rivolgersi a un operatore sanitario.
Estonian: • Patsiendid või hooldajad, kellel tekib küsimusi, peaksid rääkima tervishoiutöötajaga.
Italian: Le informazioni sul prodotto per i medicinali contenenti domperidone sono state aggiornate e a spiegazione delle nuove raccomandazioni è stata inviata una lettera agli operatori sanitari.
Estonian: Domperidooni sisaldavate ravimite ravimiteavet on ajakohastatud ning tervishoiutöötajatele on saadetud uusi soovitusi selgitav kiri.
Italian: Di norma, il medicinale non dev'essere usato per più di una settimana.
Estonian: Üldjuhul ei tohiks ravimit kasutada kauem kui üks nädal.
Italian: Le informazioni sul prodotto sono state opportunamente modificate.
Estonian: Ravimiteavet muudeti vastavalt.
Italian: Un riesame di questi dati è stato condotto in prima istanza dal comitato di valutazione dei rischi per la farmacovigilanza (PRAC).
Estonian: Kõigepealt vaatas andmed läbi ravimiohutuse riskihindamiskomitee.
Italian: Sono stati espressi timori riguardo alla possibilità che esso aumenti il rischio di effetti indesiderati sul cuore, inclusa una pericolosa irregolarità del battito cardiaco in alcuni pazienti.
Estonian: On osutatud probleemile, et see võib suurendada südamega seotud kõrvalnähtude riski, sealhulgas ohtlikult ebaregulaarsed südamelöögid mõnel patsiendil.
Italian: Inoltre, non dev'essere usato con altri medicinali che hanno effetti simili a livello cardiaco o che riducono la degradazione di domperidone nell'organismo (aumentando così il rischio di effetti indesiderati).
Estonian: Lisaks ei tohiks seda kasutada koos teiste ravimitega, millel on sarnane toime südamele või mis vähendavad domperidooni lagunemist organismis (suurendades seega kõrvalnähtude riski).
Italian: Dette raccomandazioni si basano su un'attenta considerazione dei dati sulla sicurezza e sull'efficacia di domperidone provenienti da varie fonti.
Estonian: Kõnealused soovitused põhinevad domperidooni ohutust ja efektiivsust käsitlevate eri allikatest saadud andmete hoolikal kaalumisel.
Italian: Non si è ritenuto quindi che i benefici in queste indicazioni superassero i rischi.
Estonian: Nende näidustustega seotud kasulikkust ei peetud seega suuremaks kui nendega seotud riski.
Italian: Il 23 aprile 2014 il gruppo di coordinamento per le procedure di mutuo riconoscimento e decentratemedicinali per uso umano (CMDh) ha approvato le raccomandazioni relative alla limitazione dell'uso dei medicinali contenenti domperidone.
Estonian: 23. aprillil 2014 kiitis inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm heaks domperidooni sisaldavate ravimite kasutamispiirangute soovitused.