FrancophonIA/ELRC3.0 huggingface dataset:
Bulgarian: - Комитетът взима предвид основанията за преразглеждане, подадени до 13 април 2010 г., от различните ПРУ за лекарствени продукти, съдържащи валпроева киселина/валпроат, както и обсъждането в рамките на Комитета;
Maltese: - Il-Kumitat ikkunsidra r-raġunijiet għall-eżaminazzjoni mill-ġdid sottomessi mill-MAHs varji għal valproic acid/prodotti mediċinali li fihom valproate fit-13 ta' April 2010 u d-diskussjoni fi ħdan il-Kumitat;
Bulgarian: ЗА УПОТРЕБА
Maltese: KUNDIZZJONIJIET TAL-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID
Bulgarian: План за управление на риска
Maltese: Pjan tal-Ġestjoni tar-Riskji
Bulgarian: След издаване на решение от Европейската комисия с всяко ново заявление за удължаване на показанието за лечение на мания при биполярно разстройство трябва да се предоставя
Maltese: Skont id-Deċiżjoni tal-Kummissjoni Ewropea, il-Pjan tal-Ġestjoni tar-Riskji għandu jiġi sottomess ma' kwalunkwe applikazzjoni ġdida għall-estensjoni tal-indikazzjoni rigward it-trattament tal-manija fid-disturb bipolari, kif relevanti.
Bulgarian: ПРИЛОЖЕНИЕ IV УСЛОВИЕ НА РАЗРЕШЕНИЯТА
Maltese: ANNESS IV KUNDIZZJONI TAL-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ
Bulgarian: Националните компетентни органи, координирани от референтната държава-членка, където е приложимо, гарантират, че притежателите на разрешения за употреба изпълняват следните условия:
Maltese: FIS-SUQ L-Awtoritajiet Kompetenti Nazzjonali, ikkoordinati mill-Istat Membru ta' Referenza fejn ikun il-każ, għandhom jiżguraw li l-kundizzjonijiet li ġejjin huma ssodisfati mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
Bulgarian: 92936 Paris la Défense Cedex
Maltese: 92936 Paris la Défense Cedex Franza
Bulgarian: 3, avenue de la Baltique 91140 Villebon Sur Yvette
Maltese: 3, avenue de la Baltique 91140 Villebon Sur Yvette Franza
Bulgarian: Via Pontina Km 30,400 00040 Pomezia - Roma Италия
Maltese: Via Pontina Km 30,400 00040 Pomezia - Roma L-Italja
Bulgarian: Kristina De Turck KDT Consulting Chaussée de Ninove 2 1540 Herne
Maltese: Kristina De Turck KDT Consulting Chaussée de Ninove 2 1540
Bulgarian: Generis Farmacêutica, S.A. Office Park da Beloura, Edifício 4, Quinta da Beloura 2710-444 Sintra
Maltese: Generis Farmacêutica, S.A. Office Park da Beloura, Edifício 4, Quinta da Beloura 2710-444
Bulgarian: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux
Maltese: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux Franza
Bulgarian: 92213 SAINT-CLOUD
Maltese: 92213 SAINT-CLOUD Franza
Bulgarian: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Maltese: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560
Bulgarian: капсула
Maltese: kapsula
Bulgarian: 2740-299 Porto Salvo
Maltese: 2740-299 Porto Salvo Il-Portugall
Bulgarian: 08019 Barcelona
Maltese: 08019 Barcelona Spanja
Bulgarian: Valdemāra iela 33 - 8 LV - 1010 Riga
Maltese: Kr. Valdemāra iela 33 - 8 LV - 1010
Bulgarian: Rua Quinta do Pinheiro Edifício Tejo - 6º Piso 2790-143 Carnaxide
Maltese: Rua Quinta do Pinheiro Edifício Tejo - 6º Piso 2790-143 Carnaxide Il-Portugall
Bulgarian: NL-1327 AH Almere
Maltese: NL-1327 AH Almere L-Olanda
Bulgarian: NL-2003 RN Haarlem
Maltese: NL-2003 RN Haarlem L-Olanda
Bulgarian: Kampenringweg 45 D-E NL-2803 PE Gouda
Maltese: Kampenringweg 45 D-E NL-2803 PE Gouda L-Olanda
Bulgarian: Санофи-Авентис България ЕООД бул. Ал.
Maltese: Санофи-Авентис България ЕООД бул.
Bulgarian: 11317 Tallinn
Maltese: 11317 Tallinn L-Estonja
Bulgarian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest
Maltese: SAS 117, allée des Parcs 69800 Saint-Priest Franza
Bulgarian: Norton Healthcare Limited Ivax Pharmaceuticals Ivax
Maltese: Norton Healthcare Limited Ivax Pharmaceuticals Ivax Quays
Bulgarian: HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre
Maltese: HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Id-Danimarka
Bulgarian: FI-00351 Helsinki
Maltese: FI-00351 Helsinki Il-Finlandja
Bulgarian: Edvard Thomsens Vej 14 DK-2300 København S
Maltese: Edvard Thomsens Vej 14 DK-2300 København S Id-Danimarka
Bulgarian: West Malling, Kent.
Maltese: West Malling, Kent. ME194AH
Bulgarian: TEVA UK LIMITED Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG
Maltese: TEVA UK LIMITED Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG Ir-Renju Unit
Bulgarian: D-53730 St.Augustin
Maltese: D-53730 St.Augustin Il-Ġermanja
Bulgarian: 49, avenue Georges Pompidou 92300 Levallois-Perret
Maltese: 49, avenue Georges Pompidou 92300 Levallois-Perret Franza
Bulgarian: Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien
Maltese: Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien L-Awstrija
Bulgarian: D-63741 Aschaffenburg
Maltese: D-63741 Aschaffenburg Il-Ġermanja
Bulgarian: LT-09310 Vilnius
Maltese: LT-09310 Vilnius Il-Litwanja
Bulgarian: Actavis UK Limited Whiddon Valley Barnstaple North Devon EX32 8NS
Maltese: Actavis UK Limited Whiddon Valley Barnstaple North Devon EX32 8NS Ir-Renju Unit
Bulgarian: Финландия sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22
Maltese: Il-Finlandja sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22
Bulgarian: HU-1045 Budapest
Maltese: HU-1045
Bulgarian: Largo Boccioni, 1 21040 Origgio (VA)
Maltese: Largo Boccioni, 1 21040
Bulgarian: D-79359 Riegel
Maltese: D-79359 Riegel Il-Ġermanja
Bulgarian: D-27457 Cuxhaven
Maltese: D-27457 Cuxhaven Il-Ġermanja
Bulgarian: Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem
Maltese: Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Il-Belġju
Bulgarian: Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Maltese: Lundbeck GmbH Postfach 900662 D-21046 Hamburg Il-Ġermanja
Bulgarian: Remedica Ltd Aharnon street P.O.Box 51706 3508 Lemesos
Maltese: Remedica Ltd Aharnon street P.O.Box 51706 3508 Lemesos Ċipru
Bulgarian: D-90449 Nürnberg
Maltese: D-90449 Nürnberg Il-Ġermanja
Bulgarian: D-01445 Radebeul
Maltese: D-01445 Radebeul Il-Ġermanja
Bulgarian: NL-1507 CC Zaandam
Maltese: NL-1507 CC
Bulgarian: Herts, EN6 1TL
Maltese: Herts, EN6 1TL Ir-Renju Unit
Bulgarian: EPILIM 100MG CRUSHABLE TABLET 100mg таблетка
Maltese: EPILIM 100MG CRUSHABLE TABLET 100mg pillola
Bulgarian: Heizel Esplanade b22 1020 Laken
Maltese: Heizel Esplanade b22 1020
Bulgarian: D-86156 Augsburg
Maltese: D-86156 Augsburg Il-Ġermanja
Bulgarian: Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2º - Escritório 15
Maltese: Alameda da Beloura, Edifício 1, 2º - Escritório 15
Bulgarian: Orfiril Retard таблетка
Maltese: Orfiril Retard pillola
Bulgarian: Ostpreussendamm 72-74 D-12207 Berlin
Maltese: Ostpreussendamm 72-74
Bulgarian: 61352 Bad Homburg
Maltese: 61352 Bad Homburg Il-Ġermanja
Bulgarian: 85 High Street Tunbridge Wells, TN1 1YG
Maltese: High Street Tunbridge Wells, TN1 1YG Ir-Renju Unit
Bulgarian: Limassol Industrial Estate Aharnon P.O Box 51706 3508 Limassol
Maltese: Limassol Industrial Estate Aharnon P.O Box 51706 3508 Limassol Ċipru
Bulgarian: SODIUM VALPROATE TABLETS BP 200MG (E/C)
Maltese: TABLETS BP 200MG (E/C)
Bulgarian: Esplanade Heysel B.22 B-1020 Bruxelles
Maltese: Esplanade Heysel B.22 B-1020 Bruxelles Il-Belġju
Bulgarian: D-89146 Laichingen
Maltese: D-89146 Laichingen Il-Ġermanja
Bulgarian: Absenor таблетка
Maltese: Absenor pillola
Bulgarian: Telecom Gardens Medialaan 40
Maltese: SANDOZ N.V. Telecom Gardens Medialaan 40
Bulgarian: FI-02201 Espoo
Maltese: FI-02201 Espoo Il-Finlandja
Bulgarian: Albert Basin, Royal Dock Canning Town London E16 2QJ
Maltese: Albert Basin, Royal Dock Canning Town London E16 2QJ Ir-Renju Unit
Bulgarian: Холандия sanofi-aventis Netherlands B.V.
Maltese: L-Olanda sanofi-aventis Netherlands B.V.
Bulgarian: 4879 AC Etten-Leur
Maltese: 4879 AC Etten-Leur L-Olanda
Bulgarian: Valpro TAD Lösung перорален разтвор
Maltese: Valpro TAD Lösung soluzzjoni orali
Bulgarian: RATIOPHARM GMBH Graff-Arco Strasse 3, Ulm, D
Maltese: GMBH Graff-Arco Strasse 3, Ulm, D
Bulgarian: Lach Pharma Consulting Bahnhofstr. 6
Maltese: Dr. Lach Pharma Consulting Bahnhofstr.
Bulgarian: 1325 Lysaker
Maltese: 1325 Lysaker In-Norveġja
Bulgarian: Albert Basin, Royal Docks London E16 2QJ
Maltese: Albert Basin, Royal Docks London E16 2QJ Ir-Renju Unit
Bulgarian: Orion Corporation Orionintie FI-02200 Espoo
Maltese: Orion Corporation Orionintie FI-02200 Espoo Il-Finlandja
Bulgarian: Industriestrasse 25 D-83607 Holzkirchen
Maltese: Industriestrasse 25 D-83607 Holzkirchen Il-Ġermanja
Bulgarian: Valproat-RPh Lösung перорален разтвор
Maltese: Valproat-RPh Lösung soluzzjoni orali
Bulgarian: C.F. Tietgens Boulevard 40, 5220 Odense SØ Дания
Maltese: Tietgens Boulevard 40, 5220
Bulgarian: G.L.Pharma GmbH Schlossplatz 1, A-8502 Lannach,
Maltese: G.L.Pharma GmbH Schlossplatz 1, A-8502 Lannach, L-Awstrija
Bulgarian: Sandoz d.d., Verovskova 57 1000 Ljubljana
Maltese: Sandoz d.d., Verovskova 57 1000 Ljubljana Is-Slovenja
Bulgarian: EPILIM 200 EC TABLETS
Maltese: EPILIM 200 EC
Bulgarian: Ergenyl Lösung перорален разтвор esparma GmbH Seepark 7
Maltese: Ergenyl Lösung soluzzjoni orali esparma GmbH Seepark 7
Bulgarian: EPILIM LIQUID OR SODIUM VALPROATE 200MG/5ML LIQUID
Maltese: LIQUID OR SODIUM VALPROATE 200MG/5ML LIQUID
Bulgarian: Verovškova 57 1000 Ljubljana
Maltese: Verovškova 57 1000 Ljubljana Is-Slovenja
Bulgarian: D-39116 Magdeburg espa-valept 600mg
Maltese: D-39116 Magdeburg Il-Ġermanja espa-valept 600mg
Bulgarian: Convulex Tropflösung перорален разтвор
Maltese: Convulex Tropflösung soluzzjoni orali
Bulgarian: 43,38mg / 1 ml сироп
Maltese: 43,38mg / 1 ml mistura
Bulgarian: Valproate
Maltese: VALPROIM
Bulgarian: SANDOZ GmbH Biochemiestrasse 10 A-6250 Kundl
Maltese: SANDOZ GmbH Biochemiestrasse 10 A-6250
Bulgarian: капсула, твърда
Maltese: kapsula, iebsa
Bulgarian: A-8502 Lannach
Maltese: A-8502 Lannach L-Awstrija
Bulgarian: Delepsine таблетка
Maltese: Delepsine pillola
Bulgarian: Arnethgasse 3, A-1160,
Maltese: Arnethgasse 3, A-1160, Vienna, L-Awstrija
Bulgarian: Valproat HEXAL 300mg/ml Lösung перорален разтвор
Maltese: Valproat HEXAL 300mg/ml Lösung soluzzjoni orali
Bulgarian: Ulm 89079
Maltese: D-89070 Ulm
Bulgarian: Surrey, GU1 4YS
Maltese: Surrey, GU1 4YS Ir-Renju Unit
Bulgarian: UAB ,,Sanofi Aventis" Lietuva A.
Maltese: UAB ,,Sanofi Aventis"
Bulgarian: Convulex 50 mg/ ml syrup 50 mg/ml сироп
Maltese: Convulex 50 mg/ ml syrup 50 mg/ml mistura
Bulgarian: Sanofi-Aventis France 1-13 bld Romain Rolland 75014 Paris
Maltese: Sanofi-Aventis France 1-13 bld Romain Rolland 75014
Bulgarian: WOCKHARDT UK LIMITED Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF
Maltese: WOCKHARDT UK LIMITED Ash Road North Wrexham
Bulgarian: S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti
Maltese: Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti Ir-Rumanija
Bulgarian: 1800 Vilvoorde
Maltese: 1800 Vilvoorde Il-Belġju
Bulgarian: Rua Tierno GalvanAmoreiras - Torre 3 - 12º 1099-036 Lisboa
Maltese: Rua Tierno Galvan - Amoreiras - Torre 3 - 12º
Bulgarian: Dunajska c.
Maltese: Lietuva A.
Bulgarian: VALPROSTAT 300MG 199.80 mg / 87.00 mg
Maltese: VALPROSTAT 300MG 199.80 mg / 87.
Bulgarian: ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM
Maltese: SODIO VALPROATO RATIOPHARM
Bulgarian: Convulsofin таблетка
Maltese: Convulsofin pillola
Bulgarian: 288,2 mg/5 ml сироп
Maltese: 288,2 mg/5 ml mistura
Bulgarian: 7,50g/150 ml сироп
Maltese: 7,50g/150 ml mistura
Bulgarian: Valproinsäure-ratiopharm Lösung перорален разтвор
Maltese: Valproinsäure-ratiopharm Lösung soluzzjoni orali
Bulgarian: Чехия sanofi-aventis, s.r.o.
Maltese: Ir-Repubblika Ċeka sanofi-aventis, s.r.o.
Bulgarian: EPILIM SYRUP 200MG/5ML
Maltese: SYRUP 200MG/5ML
Bulgarian: 00.-203 Warsaw
Maltese: Bonifraterska 17 Warsaw 00-203
Bulgarian: 61118 Bad Vilbel
Maltese: 61118 Bad Vilbel Il-Ġermanja
Bulgarian: Depakine таблетка
Maltese: Depakine pillola
Bulgarian: Sodium valproate oral
Maltese: SODIUM VALPROATE
Bulgarian: Convulex 300 mg kapsuly 300 mg капсула
Maltese: Convulex 300 mg kapsuly 300 mg kapsula
Bulgarian: Convulex капсула, мека
Maltese: Convulex kapsula, ratba
Bulgarian: SODIUM VALPROATE LIQUID 200MG/5ML 200mg перорален разтвор
Maltese: SODIUM VALPROATE LIQUID 200MG/5ML 200mg soluzzjoni orali
Bulgarian: D-83602 Holzkirchen
Maltese: D-83602 Holzkirchen Il-Ġermanja
Bulgarian: Valpro TAD chrono 300 mg
Maltese: Valpro TAD chrono 300 mg 300 mg
Bulgarian: Sanofi-aventis Latvia SIA Kr.
Maltese: Sanofi-aventis Latvia SIA
Bulgarian: Valpro TAD chrono 500 mg
Maltese: Valpro TAD chrono 500 mg 500 mg
Bulgarian: Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114
Maltese: Pirotta Birkirkara BKR 1114
Bulgarian: Convulex 300 mg/mlLösung zum Einnehmen 300 mg/ml перорален разтвор
Maltese: Convulex 300 mg/mlLösung zum Einnehmen 300 mg/ml soluzzjoni orali
Bulgarian: Orfiril Saft перорален разтвор
Maltese: Orfiril Saft soluzzjoni orali
Bulgarian: Convulex 150 mg kapsuly 150 mg капсула
Maltese: Convulex 150 mg kapsuly 150 mg kapsula
Bulgarian: DEPAKINE CRONO 300 mg comprimidos recubiertos обвита таблетка
Maltese: DEPAKINE CRONO 300 mg comprimidos recubiertos pillola miksija
Bulgarian: EPILIM CHRONO 200 CONTROLLED RELEASE TABLETS 200MG
Maltese: CONTROLLED RELEASE TABLETS 200MG
Bulgarian: Natriumvalproat 'ratiopharm' retard 300 mg - Filmtabletten
Maltese: Natriumvalproat 'ratiopharm' retard 300 mgFilmtabletten
Bulgarian: капсула, мека
Maltese: kapsula, ratba
Bulgarian: 200.00 mg / 87.00 mg
Maltese: 200.00 mg / 87.
Bulgarian: Convulsofin Tabletten таблетка
Maltese: Convulsofin Tabletten pillola
Bulgarian: D-83607 Holzkirchen
Maltese: D-83607 Holzkirchen Il-Ġermanja
Bulgarian: 8502 Lannach
Maltese: 8502 Lannach L-Awstrija
Bulgarian: Natriumvalproaat ratiopharm
Maltese: VALPROATE DE SODIUM RATIOPHARM
Bulgarian: EPILIM CHRONO 500 CONTROLLED RELEASE TABLETS 500MG
Maltese: CONTROLLED RELEASE TABLETS 500MG
Bulgarian: LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Maltese: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou
Bulgarian: Convulex 500 mg kapsuly 500 mg капсула
Maltese: Convulex 500 mg kapsuly 500 mg kapsula
Bulgarian: 3 A-1140 Wien
Maltese: 3 A-1140 Wien L-Awstrija
Bulgarian: 30 g перорални капки, разтвор
Maltese: 30 g qtar orali, soluzzjoni
Bulgarian: Natriumvalproat 'ratiopharm' retard 500 mg - Filmtabletten
Maltese: Natriumvalproat 'ratiopharm' retard 500 mgFilmtabletten
Bulgarian: DEPAKINE CRONO 500 mg comprimidos recubiertos обвита таблетка
Maltese: DEPAKINE CRONO 500 mg comprimidos recubiertos pillola miksija
Bulgarian: 1 Onslow Street, Guildford Surrey, GU1 4YS
Maltese: 1 Onslow Street, Guildford Surrey, GU1 4YS Ir-Renju Unit
Bulgarian: 5.764 g/100 ml сироп
Maltese: 5.764 g/100 ml mistura
Bulgarian: Propymal Enteric 450 mg 450 mg стомашно-устойчива капсула, мека
Maltese: Propymal Enteric 450 mg 450 mg kapsula gastroreżistenti, ratba
Bulgarian: Orion Corporation Postfach P.O. Box 65 FIN-02101 ESPOO
Maltese: Orion Corporation Postfach P.O. Box 65
Bulgarian: 220 mg sodium valproate and 95,8 mg valproic acid per gram гранули с изменено освобождаване
Maltese: 220 mg sodium valproate and 95,8 mg valproic acid per gram grani li jerħu l-mediċina b'mod modifikat
Bulgarian: VALPROTEK CR 300 MG (PROLONGED RELEASE) TABLETS
Maltese: VALPROTEK CR 300 MG (PROLONGED RELEASE)
Bulgarian: DEPAKINE CHRONO 500 mg филмирана таблетка с удължено освобождаване
Maltese: Depakine chrono 500 mg filmsko obložene tablet s podaljšanim sproščanjem
Bulgarian: AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren
Maltese: AbZ-Pharma GmbH Dr. Georg-Spohn-Str.
Bulgarian: BIOGARAN 15, boulevard Charles de Gaulle
Maltese: 15, boulevard Charles de Gaulle 92700 Colombes Franza
Bulgarian: AWD.pharma GmbH & Co. KG
Maltese: AWD.pharma GmbH & Co.
Bulgarian: Diplexil обвита таблетка
Maltese: Diplexil pillola miksija
Bulgarian: DEPAKINE ENTERIC 150mg таблетка
Maltese: DEPAKINE ENTERIC 150mg pillola
Bulgarian: 500,06 sodium valproate and 217,75 mg valproic acid per sachet гранули с изменено освобождаване
Maltese: 500,06 sodium valproate and 217,75 mg valproic acid per sachet grani li jerħu l-mediċina b'mod modifikat
Bulgarian: Depakine Zuur стомашно-устойчива капсула, мека
Maltese: Depakine Zuur kapsula gastroreżistenti, ratba
Bulgarian: 166,76 sodium valproate and 72,61 mg valproic acid per sachet гранули с изменено освобождаване
Maltese: 166,76 sodium valproate and 72,61 mg valproic acid per sachet grani li jerħu l-mediċina b'mod modifikat
Bulgarian: D-39116 Magdeburg espa-valept 500 mg retard 500 mg esparma GmbH Seepark 7
Maltese: D-39116 Magdeburg Il-Ġermanja espa-valept 500 mg retard 500 mg esparma GmbH Seepark 7
Bulgarian: 5,764 /100 ml сироп
Maltese: 5,764 /100 ml mistura
Bulgarian: CONVULEX 300 mg / ml 300 mg / 1 ml of drops перорални капки, разтвор
Maltese: CONVULEX 300 mg / ml 300 mg / 1 ml of drops qtar orali, soluzzjoni
Bulgarian: Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Maltese: Heumann Pharma GmbH & Co. Generica KG
Bulgarian: Propymal Enteric 600 mg 600 mg стомашно-устойчива капсула, мека
Maltese: Propymal Enteric 600 mg 600 mg kapsula gastroreżistenti, ratba
Bulgarian: VALPROATE RETARD MYLAN 500 MG
Maltese: VALPROATE RETARD MYLAN 500
Bulgarian: DEPAKINE 300 MG/5 ML
Maltese: DEPAKINE 300 MG/5 ML 300 mg/5 ml mistura
Bulgarian: D-39116 Magdeburg espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7
Maltese: D-39116 Magdeburg Il-Ġermanja espa-valept 300 mg retard 300 mg esparma GmbH Seepark 7
Bulgarian: Ergenyl chrono 300 mg 300 mg
Maltese: Ergenyl chrono 300 mg
Bulgarian: SODIUM VALPROATE TABLETS BP 500MG EC 500mg обвита таблетка
Maltese: TABLETS BP 500MG EC 500mg pillola miksija
Bulgarian: Основни послания:
Maltese: Messaġġi importanti:
Bulgarian: O АЗ ЗАПОЧВАМ ЛЕЧЕНИЕ
Maltese: O SE NIBDA TRATTAMENT
Bulgarian: Лечение на епилепсия
Maltese: Trattament tal-epilessija
Bulgarian: Биполярно разстройство <и> <мигрена>
Maltese: Disturb bipolari <u> <emigranja>
Bulgarian: Това съответства на 2 до 3 бебета на всеки 100, родени от жени, които нямат епилепсия.
Maltese: Dan jikkumpara ma' 2 sa 3 trabi minn kull 100 li jitwieldu lil nisa li m'għandhomx epilessija.
Bulgarian: Вродените дефекти, които са съобщени, включват спина бифида (при което костите на гръбначния канал не са правилно развити); лицеви и черепни малформации; малформации на сърцето, бъбреците, пикочните пътища и половите органи; дефекти на крайниците.
Maltese: Difetti tat-twelid li ġew irrappurtati jinkludu spina bifida (fejn l-għadam tas-sinsla ma jkunx żviluppat kif suppost)); mankamenti fil-wiċċ u fil-qafas għadmi tar-ras; mankamenti fil-qalb, fil-kliewi, fl-apparat tal-awrina u fl-organi sesswali; difetti fid-dirgħajn u rriġlejn.
Bulgarian: • по време на бременност (вж. точка 4.4 и 4.6).
Maltese: • fit-tqala (ara sezzjoni 4.4 u 4.6).
Bulgarian: Смята се, че до 30-40% от децата в предучилищна възраст, чиито майки са приемали валпроат по време на бременност, може да имат проблеми с развитието през ранната детска възраст.
Maltese: • Huwa stmat li sa 30-40% tat-tfal f'età qabel jidħlu l-iskola li ommijiethom jkunu ħadu valproate waqt it-tqala jista' jkollhom problemi bl-iżvilupp bikri tat-tfulija.
Bulgarian: • по време на бременност (вж. точки 4.3 и 4.6).
Maltese: • fit-tqala (ara sezzjoni 4.3 u 4.6).
Bulgarian: Годишен преглед на лечението от медицински специалист
Maltese: Reviżjoni annwali tat-trattament minn speċjalista
Bulgarian: Валпроат, като лечение за епилепсия е противопоказан при бременност, освен когато няма подходящо алтернативно лечение (вж. точки 4.3 и 4.4).
Maltese: Valproate bħala trattament għall-epilessija huwa kontraindikat fit-tqala ħlief meta ma jkunx hemm trattament alternattiv adattat (ara sezzjonijiet 4.3 u 4.4).
Bulgarian: Тест за бременност
Maltese: Test tat-tqala
Bulgarian: Валпроат има висок тератогенен потенциал и децата, с експозиция in utero на валпроат са с висок риск от вродени малформации и нарушения в развитието на нервната система (вж. точка 4.6). <Свободно избрано име> е противопоказан при следните ситуации:
Maltese: Valproate għandu potenzjal kbir ta' teratoġeniċità u tfal esposti fil-ġuf għal valproate jkollhom riskju kbir ta' malformazzjonijiet konġenitali u disturbi fl-iżvilupp newoloġiku (ara sezzjoni 4.6).
Bulgarian: Валпроат се предписва и отпуска в съответствие с програмата за предпазване от бременност при употреба на валпроат (вж. точки 4.3 и 4.4).
Maltese: Valproate jiġi ordnat b'riċetta u jingħata b'riċetta skont il-Programm ta' Prevenzjoni tat-Tqala għal Valproate (sezzjonijiet 4.3 u 4.4).
Bulgarian: Sci Rep. 2016 Nov 7;6:36250
Maltese: Nov 7;6:36250
Bulgarian: Proc Natl Acad Sci U S A.
Maltese: Proc Natl Acad Sci
Bulgarian: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substa nces/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f
Maltese: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substa nces/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f qasam tal-kura tas-saħħa permezz ta' komunikazzjoni diretta professjonali dwar il-kura tas-saħħa (DHPC).
Bulgarian: На 08 март 2017 г.
Maltese: Sci Rep. 2016
Bulgarian: Лекарствените продукти ще продължат да са включени в допълнителния списък за наблюдение.
Maltese: Il-prodotti mediċinali se jibqgħu jiġu elenkati fil-lista ta' monitoraġġ addizzjonali.
Bulgarian: Комитетът за оценка на риска при проследяване на лекарствената безопасност (PRAC) разгледа процедурата по член 31 от Директива 2001/83/ЕО за лекарствени продукти, съдържащи вещества, сродни на валпроат.
Maltese: • Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom sustanzi relatati ma' valproate.
Bulgarian: PRAC прие препоръка на 08 февруари 2018 г., която след това е разгледана от CMDh в съответствие с член 107k от Директива 2001/83/ЕО.
Maltese: Il-PRAC adotta rakkomandazzjoni, fit-8 ta' Frar 2018 li dak iż-żmien kienet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
Bulgarian: Това води до стойност, която е над 25 000 пъти пониска от AUC при жена, лекувана перорално с еквивалентна доза (еднократна перорална доза от 500 мг).
Maltese: Dan irriżulta f'valur li kien aktar minn 25,000 darba inqas mill-AUC f'mara kkurata oralment b'doża ugwali (doża orali waħda ta' 500 mg).
Bulgarian: По искане на PRAC са проведени мащабни консултации за събиране на цялата актуална информация по отношение на научните и клиничните познания чрез консултация с две научни групи (неврология и психиатрия) и за събиране на информация от здравни специалисти, от самите пациентки и техните семейства, от пациентски организации (обществени обсъждания, срещи на заинтересовани страни), които пледират за по-добро характеризиране и повишаване на осведомеността по отношение на риска от увреждане на плода при употреба на валпроат по време на бременност.
Maltese: Fuq talba tal-PRAC saret konsultazzjoni wiesgħa biex tinġabar l-aħħar informazzjoni kollha f'termini talgħarfien xjentifiku u kliniku bil-konsultazzjoni ta' żewġ gruppi xjentifiċi (newroloġija u psikjatrija), u biex tinġabar informazzjoni mill-professjonisti fil-qasam tal-kura tas-saħħa, mill-pazjenti nisa nfushom kif ukoll il-familji tagħhom, mill-organizzazzjonijiet tal-pazjenti (smigħ pubbliku, laqgħa tal-partijiet ikkonċernati) li qed iħeġġu karatterizzazzjoni aħjar u żieda fis-sensibilizzazzjoni dwar ir-riskju ta' ħsara lill-fetu meta jintuża valproate waqt it-tqala.
Bulgarian: • PRAC заключава, че мерките за минимизиране за лекарствените продукти, съдържащи валпроат или сродни вещества, трябва да се засилят чрез противопоказания при всички показания (епилепсия, биполярни разстройства и профилактика на мигрена) при жени/момичета с детероден потенциал, освен ако не са спазени условията на програмата за превенция на бременност.
Maltese: • Il-PRAC ikkonkluda li l-attivitajiet ta' miżuri ta' minimizzazzjoni għal prodotti mediċinali li fihom valproate jew sustanzi relatati għandhom jissaħħu permezz ta' kontraindikazzjoni flindikazzjonijiet kollha (epilessija, disturbi bipolari u profilassi tal-emigranja) fin-nisa/fit-tfajliet li jistgħu joħorġu tqal sakemm ma jiġux ssodisfati l-kundizzjonijiet tal-programm għallprevenzjoni tat-tqala.
Bulgarian: Ранното съобщаване на пълната информация относно рисковете от валпроат се счита за съществено.
Maltese: Komunikazzjoni bikrija ta' informazzjoni kompluta dwar ir-riskji ta' valproate hija kkunsidrata essenzjali.