natgillin/translations-raw huggingface dataset:
Domperidone Nauzelin 10 mg comprimidos recubiertos con película
Domperidon Nauzelin 10 mg comprimidos recubiertos con película
DR. REDDY'S S.R.L.
REDDY'S S.R.L.
Mediq Farma B.V.
Nizozemska Mediq Farma B.V.
Domperidone Motilium Rx 10 mg Film-coated Tablets.
Domperidon Motilium Rx 10 mg Film-coated Tablets.
Domperidone Motilium Fastmelts 10mg Tablets
Domperidon Motilium Fastmelts 10mg Tablets
Domperidone Orosperidys 10 mg comprimidos bucodispersables
Domperidon Orosperidys 10 mg comprimidos bucodispersables
Belgium domperidone Motilium-60 supp 60 mg suppository rectal use
Belgium domperidon Motilium-60 supp 60 mg čepić rektalno
92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 10 mg, granulés effervescents en sachet-dose
Domperidone maleate
Domperidon maleate
Ireland domperidone maleate
Ireland domperidon maleat
Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible
Germany domperidon DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible
Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal domperidone Remotil
Edifícios Azevedos - Estrada Nacional 117-2, Alfragide
Domperidone Motilium
Domperidon MOTILIUM
2700-451 Amadora Portugal domperidone Domperidona GP 10 mg tablet
2700-451 Amadora Portugal domperidon Domperidona GP
92654 Boulogne Cedex France domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use
92654 Boulogne Cedex France domperidon Oroperidys 10 mg 10 mg raspadljiva tableta za usta
20 mg effervescent granules
20 mg šumeće granule
Hungary domperidone Domperidon-EP 10 mg tabletta
Hungary domperidon Domperidon-EP 10 mg tabletta
Domperidone Motilium 30 mg supositorios niños
Domperidon Motilium 30 mg supositorios niños
Domperidone Motilium zetpillen voor zuigelingen 10 mg
Domperidon Motilium zetpillen voor zuigelingen 10 mg
REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus domperidone PEPTOMET FILM COATED TABLETS 10MG
REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos,
Actavis Nordic A/S Ornegardsvej 16 2820 Gentofte Denmark
Nizozemska Actavis Nordic A/S Ornegardsvej 16
Domperidone Domperidon 60 mg zetpillen
Domperidon Domperidon 60 mg zetpillen
Domperidone Domperidona Gamir 1 mg/ml suspensión oral
Domperidon Domperidona Gamir 1 mg/ml suspensión oral
Domperidone Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Domperidon Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Domperidone EG-10 10 mg tablet
Domperidone EG-10 10 mg tableta
Domperidone Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Domperidon Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Wrexham Industrial Estate Wrexham LL13 9UF
Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom domperidon maleat
Domperidone Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Domperidon Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Domperidone Motilium 10 mg Suppositories
Domperidon Motilium 10 mg Suppositories
Domperidone Motilium zetpillen voor kinderen 30 mg
Domperidon Motilium zetpillen voor kinderen 30 mg
92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 1 mg/ml, suspension buvable
92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 1 mg/ml, suspension buvable
Domperidone Motilium zetpillen voor volwassenen 60 mg
Domperidon Motilium zetpillen voor volwassenen 60 mg
Domperidone Domperidon 30 mg zetpillen
Domperidon Domperidon 30 mg zetpillen
Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
Germany domperidon DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland domperidone Domperidon Actavis 10 mg tablets
Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland domperidon Domperidon Actavis 10 mg tablets
B-2340, Beerse Belgium domperidone motilium 30 mg Suppositories
B-2340, Beerse Belgium domperidon motilium 30 mg Suppositories
Domperidone Motilium 60mg Suppositories
Domperidon Motilium 60mg Suppositories
5 mg effervescent granules
5 mg šumeće granule
Via Ippolito Rossellini 12 20124 Milano Italy
PENSA PHARMA S.P.A. Via Ippolito Rossellini 12 20124 Milano Italy
United Kingdom Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom domperidon maleat
Pharmacin B.V.
Nizozemska Pharmacin B.V.
Domperidone Motilium 10 mg comprimidos recubiertos con película
Domperidon Motilium 10 mg comprimidos recubiertos con película
ROTTAPHARM, S.L.
Španjolska ROTTAPHARM, S.L. Avda.
Austria domperidone Motilium 60 mgZäpfchen
Austria domperidon Motilium 60 mgZäpfchen
Domperidone Motilium filmomhulde tabletten 10 mg
Domperidon Motilium filmomhulde tabletten 10 mg
Austria domperidone Motilium 30 mgZäpfchen
Austria domperidon Motilium 30 mgZäpfchen
Domperidone Nauzelin 1 mg/ml suspensión oral
Domperidon Nauzelin 1 mg/ml suspensión oral
Belgium domperidone Motilium Instant-10 10 mg orodispersible tablet oral use
Belgium domperidon Motilium Instant-10 10 mg raspadljiva tableta za usta
Domperidone Domperidon JJC filmomhulde tabletten 10 mg
Domperidon Domperidon JJC filmomhulde tabletten 10 mg
First Avenue, Centrum 100
First Floor 69, St.
10 mg effervescent granules
10 mg šumeće granule
United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom domperidon maleat
10 mg coated tablet
10 mg obložena tableta
Belgium domperidone Motilium pediatrie 1 mg/ml oral suspension oral use
Belgium domperidon Motilium pediatrie 1 mg/ml oralna suspenzija kroz usta
Domperidone Motilium 30 mg Suppositories
Domperidon Motilium 30 mg Suppositories
92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, comprimé pelliculé
92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 10 mg, comprimé pelliculé
Domperidone Motilium 1mg/ml Oral Suspension
Domperidon Motilium 1mg/ml Oral Suspension
Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9° CDE 1600-160 Lissabon Portugal
Estrada da Luz, 90-9° CDE
Domperidone Domperidon JJC zetpillen voor kinderen 30 mg
Domperidon Domperidon JJC zetpillen voor kinderen 30 mg
5 mg oral suspension oral use
5 mg oralna suspenzija kroz usta
Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg
Domperidon Domperidon JJC zetpillen voor zuigelingen 10 mg
Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg
Domperidon Domperidon JJC zetpillen voor volwassenen 60 mg
Domperidone DOMPERIDONE ABC 10 mg tablet
Domperidon DOMPERIDONE ABC 10 mg tableta
Austria domperidone Motilium 10 mgZäpfchen
Austria domperidon Motilium 10 mgZäpfchen
Domperidone OROPERIDYS 10 mg 10 mg tablet
Domperidon OROPERIDYS 10 mg 10 mg tableta
49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable.
49, avenue Georges Pompidou 92300 Levallois-Perret France domperidon DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable.
Czech Republic Pierre Fabre Medicament 45 Place Abel Gance
Češka Republika Pierre Fabre Medicament 45 Place Abel Gance
92517 Boulogne Billancourt Cedex France domperidone DOMPERIDONE EG 20 mg, comprimé pelliculé sécable.
92517 Boulogne Billancourt Cedex France domperidon DOMPERIDONE EG 20 mg, comprimé pelliculé sécable.
60 mg suppository rectal use
60 mg čepić rektalno
Belgium domperidone Domperidone EG-10 10 mg orodispersible tablet oral use
Belgium domperidon Domperidone EG-10 10 mg raspadljiva tableta za usta
75116 Paris domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
France domperidon DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible
49, avenue Georges Pompidou 92300 Levallois-Perret France domperidon DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible
92517 Boulogne Billancourt Cedex France domperidone DOMPERIDONE EG 10 mg, comprimé orodispersible
92517 Boulogne Billancourt Cedex France domperidon DOMPERIDONE EG 10 mg, comprimé orodispersible
Belgium domperidone Motilium-30 supp 30 mg suppository rectal use
Domperidon Motilium-30 supp 30 mg čepić rektalno
Domperidone Motilium 10mg FilmCoated Tablets
Domperidon Motilium 10mg FilmCoated Tablets
Domperidone Motilium 1 mg/ ml suspensión oral
Domperidon Motilium 1 mg/ ml suspensión oral
15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.
15, boulevard Charles de Gaulle 92700 Colombes France domperidon DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.
Johnson & Johnson Consumer B.V. Rooseveltweg 15
Nizozemska Johnson & Johnson Consumer B.V.
Domperidone Domperidon Accord 10 mg, tabletten
Domperidon Domperidon Accord 10 mg, tabletten
Domperidone Domperidon Sandoz 10 mg, tabletten
Domperidon Domperidon Sandoz 10 mg, tabletten
Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
Nizozemska Stada Arzneimittel AG Stadastrasse 2-18
2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablet
Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal domperidon Domperidona Ciclum 10 mg tableta
Domperidone Domperidon Actavis 10 mg, omhulde tabletten
Domperidon Domperidon Actavis 10 mg, omhulde tabletten
92517 Boulogne Billancourt Cedex France domperidone DOMPERIDONE EG 10 mg, comprimé pelliculé
92517 Boulogne Billancourt Cedex France domperidon DOMPERIDONE EG 10 mg, comprimé pelliculé
Domperidone Domperidon STADA 10 mg tabletten
Domperidon Domperidon STADA 10 mg tabletten
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.
Domperidone Domperidon PCH 10, filmomhulde tabletten 10 mg
Domperidon Domperidon PCH 10, filmomhulde tabletten 10 mg
15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 10 mg,
15, boulevard Charles de Gaulle 92700 Colombes France domperidon DOMPERIDONE BIOGARAN 10 mg,
15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE ALMUS 10 mg, comprimé pelliculé
15, boulevard Charles de Gaulle 92700 Colombes France domperidon DOMPERIDONE ALMUS 10 mg, comprimé pelliculé
Domperidone Domperidon Faribérica 10 mg, tabletten
Domperidon Domperidon Faribérica 10 mg, tabletten
Domperidone Domperidon Bellwood 10 mg, tabletten
Domperidon Domperidon Bellwood 10 mg, tabletten
Via Pavia 6 20136 Milano Italy
CRINOS S.P.A. Via Pavia 6 20136 Milano Italy
Domperidone Domperidon 10 PCH, filmomhulde tabletten 10 mg
Domperidon Domperidon 10 PCH, filmomhulde tabletten 10 mg
49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé
49, avenue Georges Pompidou 92300 Levallois-Perret France domperidon DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé
QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE QUALIMED 10 mg,
QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé
75116 Paris domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
France domperidon DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
10 mg suppository rectal use
10 mg čepić rektalno
Domperidone Domperidon 10 mg Pharmachemie, tabletten
Domperidon Domperidon 10 mg Pharmachemie, tabletten
20 mg orodispersible tablet oral use
20 mg raspadljiva tableta za usta
Domperidone Domperidon 10 mg tabletten
Domperidon Domperidon 10 mg tabletten
Domperidone Kruidvat Domperidon 10 mg, tabletten
Domperidon Kruidvat Domperidon 10 mg, tabletten
30 mg suppository rectal use
30 mg čepić rektalno
Domperidone Domperidon CF 10 mg, tabletten
Domperidon Domperidon CF 10 mg, tabletten
10 mg dispersible tablet
10 mg raspadljiva tableta za usta
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé orodispersible
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE MYLAN 10 mg, comprimé orodispersible
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone PERIDYS 1 mg/ml, suspension buvable
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon PERIDYS 1 mg/ml, suspension buvable
75116 Paris domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
France domperidon DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
Domperidone DOMPERIDONE FG 10 mg tablet
Domperidon DOMPERIDONE FG 10 mg tableta
1MG/ML
ORAL SUSPENSION 1MG/ML
Domperidone mylan 10 mg film-coated tablet
Domperidone mylan 10 mg filmom obložena tableta
Domperidone Domperidon Mylan 10 mg, tabletten
Domperidon Domperidon Mylan 10 mg, tabletten
5 mg chewable tablet
5 mg šumeća tableta
Domperidone Domperidon Mdq 10 mg, tabletten
Domperidon Domperidon Mdq 10 mg, tabletten
DOMPERIDONE MOTILIUM 10 mg 10 mg film-coated tablet
DOMPERIDON MOTILIUM 10 mg 10 mg filmom obložena tableta
Domperidone Domperidon Actavis 10 mg, tabletten
Domperidon Domperidon Actavis 10 mg, tabletten
Domperidone EG 10 mg tablet
Domperidone EG 10 mg tableta
Domperidone Domperidon Pharmacin 10 mg, tabletten
Domperidon Domperidon Pharmacin 10 mg, tabletten
Belgium Pierre Fabre Médicament 45 place Abel Gance
Španjolska Pierre Fabre Médicament 45 place Abel Gance
Domperidone Domperidon Actavis 10 mg tablet
Domperidon Domperidon Actavis 10 mg tableta
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
Domperidone Domperidon Kela 10 mg, tabletten
Domperidon Domperidon Kela 10 mg, tabletten
92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable
110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France domperidon DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable
Domperidone DOMPERIDONE EG 10 mg tablet
Domperidon DOMPERIDONE EG 10 mg tableta
DOMPERIDONE OROPERIDYS 10 mg 10 mg orodispersible tablet oral use
DOMPERIDON OROPERIDYS 10 mg 10 mg raspadljiva tableta za usta
Domperidone Domperidon Sofar 10 mg, tabletten
Domperidon Domperidon Sofar 10 mg, tabletten
Domperidone Domperidon 10 mg PCH, tabletten
Domperidon Domperidon 10 mg PCH, tabletten
92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 10 mg, comprimé orodispersible
110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France domperidon DOMPERIDONE TEVA 10 mg, comprimé orodispersible
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone PERIDYS 10 mg, comprimé pelliculé
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon PERIDYS 10 mg, comprimé pelliculé
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone BIPERIDYSFLASH 20 mg, comprimé orodispersible
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon BIPERIDYSFLASH 20 mg, comprimé orodispersible
Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora Portugal domperidone Cinet
Rua Manuel Ribeiro de Pavia, 1 - 1ºVenda Nova
B-2340, Beerse Belgium domperidone MOTILIUM ORAL SUSPENSION
B-2340, Beerse Belgium domperidon MOTILIUM
92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 10 mg, comprimé pelliculé
110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France domperidon DOMPERIDONE TEVA 10 mg, comprimé pelliculé
Domperidone Maleato
Domperidone Maleat
Domperidone DOMPERIDONE DR. REDDY'S
Domperidon DOMPERIDONE DR.
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable
Janssen-Cilag Kft. Tó park
Janssen-Cilag Kft.
Domperidone Domperidon 10 mg, tabletten
Domperidon Domperidon 10 mg, tabletten
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone BIPERIDYS 20 mg, comprimé pelliculé sécable
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon BIPERIDYS 20 mg, comprimé pelliculé sécable
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon OROPERIDYS
10 mg orodispersible tablet oral use
10 mg tableta za oralnu suspenziju
Healthypharm B.V. Nieuwe Donk 3
Nizozemska Healthypharm B.V.
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg orodispersible tablets
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon Oroperidys 10 mg orodispersible tablets
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone OROPERIDYS 10 mg, comprimé orodispersible
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon OROPERIDYS 10 mg, comprimé orodispersible
Domperidon teva 10 mg film-coated tablet
Domperidon DOMPERIDONE TEVA 10 mg filmom obložena tableta
1 mg/ml oral suspension oral use
1 mg/ml oralna suspenzija kroz usta
Avda.
Str.
Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany
2 78467 Konstanz Germany
Pharmachemie B.V. Swensweg 5
GERMED PHARMA S.P.A. Via Cantù 11
Portugal domperidone Domperidona Mylan 10 mg film-coated tablet
Portugal domperidon Domperidona Wynn 10 mg tableta
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon Oroperidys 10 mg 10 mg raspadljiva tableta za usta
Dubrova 308 52220 Labin Croatia
Apolonia d.o.o. Dubrova 308 52220 Labin Croatia
Orchard Business Centre St Barnabas Close Allington Maidstone Kent ME16 OJZ England
St Barnabas Close Allington Maidstone Kent ME16 OJZ England
ZYLINDERAMPULLEN
VASOKONSTRIKTORZYLINDERAMPULLEN
Septodont Ltd Unit R & S
Septodont Ltd Unit R & S Orchard Business Centre
Dental use Perineural use Submucosal use Infiltration
Dentalno Perineuralno Submukozno Infiltracijom
3% without vasoconstrictor
3% without vasoconstrictor Otopina za injekciju Dentalno
Infiltration Perineural use
Infiltracijom Perineuralno
Perineural use Submucosal use
Perineuralno Submukozno
Dental use Perineural use
Dentalno Perineuralno
Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Laboratoires Septodont 58, rue du Pont de Créteil
Spécialités Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Spécialités Septodont 58, rue du Pont de Créteil
Laboratoires Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-des-Fossés Cedex
94107 Saint-Maur-desFossés Cedex France
technology'.
Ta tehnologija
EMA/430531/2016 Rev 1 EMEA/H/C/003846
EMA/430531/2016 EMEA/H/C/003846
In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Osim toga, Odbor je doveo u pitanje predloženu metodu sterilizacije lijeka.
What is Kyndrisa?
Što je Kyndrisa?
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se liječniku koji vam daje terapiju.
It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood.
Ta bolest uzrokuje progresivno slabljenje i gubitak funkcije mišića i obično dovodi do smrti u adolescenciji ili ranoj odrasloj dobi.
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.
Tvrtka je navela da namjerava prekinuti razvoj lijeka, ali da namjerava, u suradnji s liječnicima, bolesnicima i lokalnim regulatornim tijelima, bolesnicima koji se trenutačno liječe omogućiti pristup preostalim zalihama lijeka Kyndrisa.
After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues.
Nakon što je CHMP ocijenio odgovore proizvođača na posljednji popis pitanja, još su uvijek postojala neka važna neriješena pitanja.
Kyndrisa is a medicine that contains the active substance drisapersen.
Kyndrisa je lijek koji sadrži djelatnu tvar drisapersen.
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.
Nadalje, sigurnosni profil lijeka nije se smatrao zadovoljavajućim, osobito zbog rizika od dugotrajnih reakcija na mjestu ubrizgavanja (kao što su oticanje, upala i ulceracije), što bi moglo negativno utjecati na kvalitetu života, te zbog rizika od trombocitopenije (niskog broja trombocita), zbog čega bolesnici mogu biti u opasnosti od teških komplikacija povezanih s krvarenjem.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Zahtjev je povučen nakon što je CHMP ocijenio inicijalnu dokumentaciju koju je tvrtka dostavila i sastavio popise pitanja.
The studies compared the effects of Kyndrisa with placebo (a dummy treatment) and the main measure of effectiveness was the change in the distance the patient could walk in six minutes after 24 or 48 weeks of treatment.
U ispitivanjima su učinci lijeka Kyndrisa uspoređeni s placebom (slijepo liječenje), a glavno mjerilo djelotvornosti bila je promjena u udaljenosti koju bolesnik može prohodati u roku od šest minuta nakon 24 tjedna ili 48 tjedana liječenja.
Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen)
Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Kyndrisa (drisapersen)
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.
Dana 31. svibnja 2016. tvrtka BioMarin International Limited službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Kyndrisa za liječenje Duchenneove mišićne distrofije.
Kyndrisa was expected to be used for the treatment of Duchenne muscular dystrophy in patients aged 5 years and older who are able to walk and whose disease is due to certain genetic mutations (defects) that can be treated with ‘exon 51 skipping technology'.
Lijek Kyndrisa trebao se koristiti za liječenje Duchenneove mišićne distrofije u bolesnika u dobi od 5 ili više godina koji mogu hodati i čija je bolest uzrokovana određenim genskim mutacijama (oštećenjima) koje se mogu liječiti „tehnologijom preskakanja egzona 51”.
Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6.
Duchenneova mišićna distrofija teška je genska bolest koja većinom pogađa dječake i za koju se dijagnoza obično uspostavlja prije navršene 6. godine.
This technology enables the protein-making apparatus in cells to skip some areas of the dystrophin gene and allow the production of a shortened but partially working dystrophin protein.
omogućuje da stanični aparat za izradu proteina preskoči određena područja gena distrofina i omogući proizvodnju skraćenog, ali djelomično funkcionalnog proteina distrofina.