FrancophonIA/ELRC3.0 huggingface dataset:
English: Healthypharm B.V. Nieuwe Donk 3
Romanian: Ţările de Jos Healthypharm B.V. Nieuwe Donk 3
English: 2031 GA Haarlem The Netherlands
Romanian: 2031 GA Haarlem
English: Archimedesweg 2 2333 CN Leiden The Netherlands
Romanian: 2333 CN Leiden The Netherlands
English: mg/100 ml syrup
Romanian: 100 mg/100 ml sirop
English: Via Cesarea 11/10 16121 Genova Italy
Romanian: ALMUS S.R.L. Via Cesarea 11/10 16121 Genova Italy
English: Belgium Apotex NV Av Etienne Demunter 5/8 1090 Brussels
Romanian: Av Etienne Demunter 5/8 1090 Brussels Belgium
English: MEDICAMENT 10 mg, comprimé orodispersible
Romanian: MEDICAMENT 10 mg, comprimé orodispersible comprimate orodispersabile
English: Pharmachemie B.V. Swensweg 5
Romanian: Ţările de Jos Pharmachemie B.V. Swensweg 5
English: United Kingdom Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
Romanian: Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
English: Hamwells Business Park Unit No7, Hardicker Street
Romanian: Ţările de Jos Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No7, Hardicker Street
English: Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17
Romanian: Luxemburg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17
English: United Kingdom Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate
Romanian: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate
English: Belgium Kela Pharma nv Industriepark 68
Romanian: Ţările de Jos KELA Pharma nv Industriepark West 68
English: 1 mg/ml suspension
Romanian: 1 mg/ml suspensie
English: Johnson & Johnson Consumer B.V. Rooseveltweg 15
Romanian: Ţările de Jos Johnson & Johnson Consumer B.V. Rooseveltweg 15
English: Domperidone Motilium Tropfen 10 mg oral drops, suspension
Romanian: Domperidone Motilium Tropfen 10 mg picături orale, suspensie
English: United Kingdom Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
Romanian: Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
English: United Kingdom McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Romanian: McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom domperidone maleate
English: United Kingdom Manx Healthcare Limited Taylor Group House
Romanian: Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick
English: LABORATORIOS DR. ESTEVE, S.A. Avda.
Romanian: ESTEVE, S.A. Avda.
English: DR. REDDY'S S.R.L.
Romanian: REDDY'S S.R.L.
English: Baarnsche Dijk 1 3741 LN Baarn The Netherlands
Romanian: 3741 LN Baarn
English: Via Firenze, 40 20060 Trezzano Rosa - Milano Italy
Romanian: SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa - Milano Italy
English: Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17
Romanian: Johnson & Johnson Consumer N.V. Antwerpseweg 15-17
English: Domperidone Domperidona Gamir 10 mg cápsulas duras
Romanian: Domperidone Domperidona Gamir 10 mg cápsulas duras capsule
English: United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidone Domperidone 1mg/ml Oral
Romanian: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidone Domperidone 1mg/ml Oral
English: Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin Ireland
Romanian: First Floor 69, St. Patricks Road Dalkey, Co.
English: Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
Romanian: Ţările de Jos Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
English: 1 mg/ml oral suspension oral use
Romanian: 1 mg/ml suspensie orală administrare orală
English: CRISTERS 22 quai Gallieni 92150 Suresnes France domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Romanian: CRISTERS 22 quai Gallieni 92150 Suresnes France domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible comprimate orodispersabile
English: United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
Romanian: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
English: Wise Pharmaceuticals Ltd.
Romanian: Ţările de Jos Bellwood Pharmaceuticals Ltd.
English: Veluwezoom 22 1327 AH Almere The Netherlands
Romanian: 1327 AH Almere The Netherlands
English: Apothekers, zetpillen
Romanian: Apothekers, zetpillen supozitoare administrare rectală
English: 1070-274 Lisboa Portugal domperidone Domperidona Wynn 10 mg tablet
Romanian: 1070-274 Lisboa Portugal domperidone Domperidona Wynn 10 mg
English: 2794-093 Carnaxide Portugal domperidone Domperidona ToLife 10 mg tablet
Romanian: 2794-093 Carnaxide Portugal domperidone Domperidona ToLife 10 mg
English: Hertogswetering 159 3543 AS Utrecht The Netherlands
Romanian: 3543 AS Utrecht
English: Belgium domperidone Motilium pediatrie 1 mg/ml oral suspension oral use
Romanian: Belgium domperidone Motilium pediatrie 1 mg/ml suspensie orală administrare orală
English: 2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablet
Romanian: 2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Romanian: Eurogenerics N.V. Heizel Esplanade b22 1020 Brussels Belgium
English: 2700-451 Amadora Portugal domperidone Domperidona GP 10 mg tablet
Romanian: 2700-451 Amadora Portugal domperidone Domperidona GP 10 mg
English: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux domperidone DOMPERIDONE RPG 10 mg, comprimé pelliculé
Romanian: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux
English: ROTTAPHARM, S.L.
Romanian: ROTTAPHARM, S.L. Avda.
English: Via Firenze 40
Romanian: Ţările de Jos Sofar S.p.A. Via Firenze 40
English: 20 mg / 15 mg tablet
Romanian: 20 mg / 15 mg
English: Actavis Nordic A/S Ornegardsvej 16 2820 Gentofte Denmark
Romanian: Ţările de Jos Actavis Nordic A/S Ornegardsvej 16
English: Via Messina 38 20154 Milano Italy
Romanian: TEVA ITALIA S.R.L. Via Messina 38 20154 Milano Italy
English: 20 mg/ 19 mg tablet
Romanian: 20 mg/ 19 mg
English: Northbridge Road, Berkhamsted Hertfordshire
Romanian: Bristol Laboratories Limited Unit 3, Canalside Northbridge Road, Berkhamsted Hertfordshire
English: Karla Engliše 3201/6
Romanian: Republica Cehă Janssen-Cilag s.r.o. Karla Engliše 3201/6
English: Belgium domperidone Motilium Instant-10 10 mg orodispersible tablet oral use
Romanian: Belgium domperidone Motilium Instant-10 10 mg comprimate orodispersabile
English: Belgium domperidone Motilium-60 supp 60 mg suppository rectal use
Romanian: Belgium domperidone Motilium-60 supp 60 mg supozitoare administrare rectală
English: Belgium domperidone Motilium-30 supp 30 mg suppository rectal use
Romanian: Belgium domperidone Motilium-30 supp 30 mg supozitoare administrare rectală
English: Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible
Romanian: Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible comprimate orodispersabile
English: Wrexham Industrial Estate Wrexham LL13 9UF
Romanian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom domperidone maleate
English: 92654 Boulogne Cedex France domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use
Romanian: 92654 Boulogne Cedex France domperidone Oroperidys 10 mg 10 mg comprimate orodispersabile
English: Via Ippolito Rossellini 12 20124 Milano Italy
Romanian: PENSA PHARMA S.P.A. Via Ippolito Rossellini 12 20124 Milano Italy
English: 2730-055 Barcarena Portugal domperidone Motilium Rapid
Romanian: 2730-055 Barcarena Portugal domperidone Motilium Rapid comprimate orodispersabile
English: Luxembourg Pierre Fabre Médicament 45 place Abel Gance
Romanian: Luxemburg Pierre Fabre Médicament 45 place Abel Gance
English: Motilium Instants 10 mg orodispersible tablet oral use
Romanian: Motilium Instants 10 mg comprimate orodispersabile
English: Domperidone Orosperidys 10 mg comprimidos bucodispersables
Romanian: Domperidone Orosperidys 10 mg comprimidos bucodispersables comprimate orodispersabile
English: Czech Republic Pierre Fabre Medicament 45 Place Abel Gance
Romanian: Republica Cehă Pierre Fabre Medicament 45 Place Abel Gance
English: United Kingdom Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Romanian: Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom domperidone maleate
English: Domperidone Motilium 30 mg supositorios niños
Romanian: Domperidone Motilium 30 mg supositorios niños supozitoare administrare rectală
English: Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland domperidone Domperidon Actavis 10 mg tablet
Romanian: Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland domperidone Domperidon Actavis 10 mg
English: Belgium domperidone Domperidone EG-10 10 mg orodispersible tablet oral use
Romanian: Belgium domperidone Domperidone EG-10 10 mg comprimate orodispersabile
English: United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Romanian: Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom domperidone maleate
English: Domperidone DOMPERIDONE ABC 10 mg tablet
Romanian: Domperidone DOMPERIDONE ABC 10 mg
English: Domperidone Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Romanian: Domperidone Domperidon 30 PCH voor kinderen, zetpillen 30 mg supozitoare administrare rectală
English: Domperidone EG-10 10 mg tablet
Romanian: Domperidone EG-10 10 mg
English: Via Pavia 6 20136 Milano Italy
Romanian: CRINOS S.P.A. Via Pavia 6 20136 Milano Italy
English: Via Egadi 7
Romanian: LABORATORI ALTER S.R.L. Via Egadi 7
English: 75116 Paris domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
Romanian: France domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
English: Domperidone OROPERIDYS 10 mg 10 mg tablet
Romanian: Domperidone OROPERIDYS 10 mg 10 mg
English: Domperidone Motilium 10 mg Suppositories
Romanian: Domperidone Motilium 10 mg Suppositories supozitoare administrare rectală
English: Domperidone DOMPERIDONE DR. REDDY'S
Romanian: Domperidone DOMPERIDONE DR.
English: Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
Romanian: Ţările de Jos Stada Arzneimittel AG Stadastrasse 2-18
English: Domperidone Domperidon JJC zetpillen voor kinderen 30 mg
Romanian: Domperidone Domperidon JJC zetpillen voor kinderen 30 mg supozitoare administrare rectală
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible
Romanian: 49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible comprimate orodispersabile
English: Austria domperidone Motilium 60 mgZäpfchen
Romanian: Austria domperidone Motilium 60 mgZäpfchen supozitoare administrare rectală
English: Domperidone Motilium zetpillen voor zuigelingen 10 mg
Romanian: Domperidone Motilium zetpillen voor zuigelingen 10 mg supozitoare administrare rectală
English: Domperidone Motilium 60mg Suppositories
Romanian: Domperidone Motilium 60mg Suppositories supozitoare administrare rectală
English: 75116 Paris domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
Romanian: France domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
English: DOMPERIDONE OROPERIDYS 10 mg 10 mg orodispersible tablet oral use
Romanian: DOMPERIDONE OROPERIDYS 10 mg 10 mg comprimate orodispersabile
English: Domperidone Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Romanian: Domperidone Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg supozitoare administrare rectală
English: 92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 10 mg, comprimé orodispersible
Romanian: 92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 10 mg, comprimé orodispersible comprimate orodispersabile
English: Austria domperidone Motilium 30 mgZäpfchen
Romanian: Austria domperidone Motilium 30 mgZäpfchen supozitoare administrare rectală
English: Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg
Romanian: Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg supozitoare administrare rectală
English: Domperidone Motilium 30 mg Suppositories
Romanian: Domperidone Motilium 30 mg Suppositories supozitoare administrare rectală
English: Portugal domperidone Domperidona Mylan 10 mg film-coated tablet
Romanian: Portugal domperidone Domperidona Mylan 10 mg
English: B-2340, Beerse Belgium domperidone motilium 30 mg Suppositories
Romanian: B-2340, Beerse Belgium domperidone motilium 30 mg Suppositories supozitoare administrare rectală
English: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
Romanian: France domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose granule efervescente
English: Domperidone Motilium zetpillen voor kinderen 30 mg
Romanian: Domperidone Motilium zetpillen voor kinderen 30 mg supozitoare administrare rectală
English: Leidapharm B.V.
Romanian: Ţările de Jos Leidapharm B.V. Archimedesweg 2
English: 75116 Paris domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
Romanian: France domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
English: 92517 Boulogne Billancourt Cedex France domperidone DOMPERIDONE EG 10 mg, comprimé orodispersible
Romanian: 92517 Boulogne Billancourt Cedex France domperidone DOMPERIDONE EG 10 mg, comprimé orodispersible comprimate orodispersabile
English: Molenvliet 103
Romanian: Ţările de Jos Pharmacin B.V. Molenvliet 103
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé orodispersible
Romanian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé orodispersible comprimate orodispersabile
English: Via Manunzio 7
Romanian: DOC GENERICI S.R.L. Via Manunzio 7
English: Domperidone Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Romanian: Domperidone Domperidon 60 PCH voor volwassenen, zetpillen 60 mg supozitoare administrare rectală
English: Austria domperidone Motilium 10 mgZäpfchen
Romanian: Austria domperidone Motilium 10 mgZäpfchen supozitoare administrare rectală
English: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
Romanian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
English: Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg
Romanian: Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg supozitoare administrare rectală
English: 15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible
Romanian: 15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible comprimate orodispersabile
English: Domperidone Domperidon Actavis 10 mg, omhulde tabletten
Romanian: Domperidone Domperidon Actavis 10 mg, omhulde tabletten drajeuri
English: Actavis B.V.
Romanian: Apotex NV
English: Domperidone DOMPERIDONE FG 10 mg tablet
Romanian: Domperidone DOMPERIDONE FG 10 mg
English: Domperidone Tablets 10mg
Romanian: Domperidone Tablets 10mg drajeuri
English: Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
Romanian: 1-10 Constantinoupoleos St.
English: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible
Romanian: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris
English: Domperidone Motilium zetpillen voor volwassenen 60 mg
Romanian: Domperidone Motilium zetpillen voor volwassenen 60 mg supozitoare administrare rectală
English: Via Winckelmann 1 20146 Milano Italy
Romanian: PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano Italy
English: Janssen-Cilag Kft. Tó park
Romanian: Janssen-Cilag Kft.
English: Via Cantù 11
Romanian: GERMED PHARMA S.P.A. Via Cantù 11
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone BIPERIDYSFLASH 20 mg, comprimé orodispersible
Romanian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone BIPERIDYSFLASH 20 mg, comprimé orodispersible comprimate orodispersabile
English: Mylan B.V.
Romanian: Ţările de Jos Mylan B.V. Dieselweg 25
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible
Romanian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible comprimate orodispersabile
English: Burton Upon Trent, Staffordshire DE14 2WX
Romanian: Focus Pharmaceuticals Limited Unit 5, Faraday Court First Avenue, Centrum 100 Burton Upon Trent, Staffordshire DE14 2WX
English: Domperidone Domperidon Actavis 10 mg tablet
Romanian: Domperidone Domperidon Actavis 10 mg
English: Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany
Romanian: 2 78467 Konstanz Germany
English: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon domperidone DOMPERIDONE ARROW 10 mg, comprimé orodispersible
Romanian: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
English: Domperidone DOMPERIDONE EG 10 mg tablet
Romanian: Domperidone DOMPERIDONE EG 10 mg
English: PIERRE FABRE PHARMA S.R.L.
Romanian: AbZ Pharma GmbH Graf-Arco-Str.
English: Mediq Farma B.V.
Romanian: Ţările de Jos Mediq Farma B.V. Hertogswetering 159
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone OROPERIDYS 10 mg, comprimé orodispersible
Romanian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone OROPERIDYS 10 mg, comprimé orodispersible comprimate orodispersabile
English: Centrafarm B.V.
Romanian: Ţările de Jos Centrafarm B.V. Nieuwe Donk 3
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg orodispersible tablets
Romanian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg orodispersible tablets comprimate orodispersabile
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use
Romanian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg 10 mg comprimate orodispersabile
English: Domperidone EG 10 mg tablet
Romanian: Domperidone EG 10 mg
English: Periodontal use
Romanian: Administrare periodontală
English: Dubrova 308 52220 Labin Croatia
Romanian: Apolonia d.o.o. Dubrova 308 52220 Labin Croatia
English: Gingival use
Romanian: Administrare gingivală
English: BIOCAINE 3% PLAIN
Romanian: SCANDONEST 3% PLAIN BIOCAINE 3% PLAIN
English: Annex I List of medicinal products and presentations
Romanian: Lista cu deţinătorul(ii) autorizaţiei de punere pe piaţă / solicitantul(ţii)
English: Dental use Perineural use Submucosal use Infiltration
Romanian: Administrare dentară Administrare perineurală Administrare submucoasă Infiltrație
English: 3% without vasoconstrictor
Romanian: 3% without vasoconstricto r
English: Perineural use Infiltration
Romanian: Administrare perineurală Infiltrație
English: Infiltration Perineural use
Romanian: Infiltrație Administrare perineurală
English: SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
Romanian: MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
English: Dental use Perineural use
Romanian: Administrare dentară Administrare perineurală
English: Perineural use Submucosal use
Romanian: Administrare perineurală Administrare submucoasă
English: ZYLINDERAMPULLEN
Romanian: Soluție injectabilă în cartuș
English: EMA/430531/2016 Rev 1 EMEA/H/C/003846
Romanian: EMA/430531/2016 EMEA/H/C/003846
English: Kyndrisa is a medicine that contains the active substance drisapersen.
Romanian: Kyndrisa este un medicament care conține substanța activă drisapersen.
English: What is Kyndrisa?
Romanian: Ce este Kyndrisa?
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen)
Romanian: Retragerea cererii de autorizare de introducere pe piață pentru Kyndrisa (drisapersen)
English: The company stated that it intended to stop the development of the medicine, but that it plans to work with doctors, patients and local regulatory authorities to allow currently treated patients to access the remaining supply of Kyndrisa.
Romanian: Compania a precizat că intenționează să oprească dezvoltarea medicamentului, dar că își propune să lucreze împreună cu medicii, pacienții și autoritățile de reglementare pentru a le permite pacienților aflați în prezent sub tratament să aibă acces la cantitatea rămasă de Kyndrisa.
English: The Committee considered that data from the clinical studies did not sufficiently demonstrate a beneficial effect of Kyndrisa: the main study did not show any benefit in patients with the condition, while two other studies failed to consistently show a beneficial effect.
Romanian: Comitetul a considerat că datele din studiile clinice nu au demonstrat în mod suficient vreun efect benefic al Kyndrisa: studiul principal nu a demonstrat niciun beneficiu la pacienții cu această afecțiune, în timp ce celelalte două studii nu au reușit să demonstreze în mod consecvent un efect benefic.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues.
Romanian: După evaluarea de către CHMP a răspunsurilor companiei la ultima rundă de întrebări, mai rămăseseră încă unele probleme importante nerezolvate.
English: Kyndrisa was investigated in three studies in a total of 290 patients with Duchenne muscular dystrophy.
Romanian: Kyndrisa a fost investigat în trei studii care au cuprins un total de 290 de pacienți cu distrofie musculară Duchenne.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Romanian: Cererea a fost retrasă după ce CHMP finalizase evaluarea documentației prezentate de companie și formulase listele de întrebări.
English: Further, the safety profile of the medicine was not considered satisfactory, particularly because of the risk of persisting reactions at the injection site (such as swelling, inflammation and ulceration) which could have a negative impact on quality of life, and the risk of thrombocytopenia (low blood platelet counts) which could put patients at risk of serious bleeding complications.
Romanian: În plus, profilul de siguranță al medicamentului nu a fost considerat satisfăcător, în special din cauza riscului de apariție a unor reacții adverse persistente la locul de injectare (cum ar fi umflare, inflamare și ulcerație), care ar putea avea un impact negativ asupra calității vieții, precum și din cauza riscului de apariție a trombocitopeniei (număr scăzut de globule albe în sânge), care ar putea supune pacienții unui risc de complicații hemoragice grave.
English: It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood.
Romanian: Boala determină, în mod progresiv, slăbiciune și pierderea funcției musculare și, de obicei, duce la deces în perioada adolescenței sau într-o fază timpurie a vârstei adulte.
English: On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy.
Romanian: La data de 31 mai 2016, BioMarin International Limited a informat oficial Comitetul pentru medicamente de uz uman (CHMP) că dorește să își retragă cererea de autorizare de introducere pe piață pentru Kyndrisa, pentru tratamentul distrofiei musculare Duchenne.