FrancophonIA/ELRC3.0 huggingface dataset:
Croatian: Cilj dizajna ispitivanja treba biti ocjena i kvantificiranje djelotvornosti mjera za smanjivanje rizika, te isti treba uključivati analizu i ocjenu prije i nakon implementacije.
Bulgarian: Дизайнът на проучването трябва да се стреми към оценка и изчисление на ефективността на мерките за минимизиране на риска и следва да включва анализ и оценка преди и след прилагането.
Croatian: Nadležna državna tijela države(a) članice(a) ili referentne(ih) države(a) članice(a), gdje je to primjenjivo, osigurati će ispunjavanje sljedećih uvjeta od strane nositelja odobrenja:
Bulgarian: Националните компетентни органи на държавата членка (държавите членки) или референтната държава членка (референтните държави членки), ако е приложимо, трябва да гарантират, че ПРУ е(са) изпълнил(и) следните условия:
Croatian: U roku od 6 mjeseci u dogovoru s
Bulgarian: В рамките на 6 месеца от споразумението на Координационната група.
Croatian: Prvo privremeno izvješće dostavit će se PRAC-u:
Bulgarian: Първият междинен доклад трябва да се представи на PRAC:
Croatian: Nositelji odobrenja za stavljanje u promet lijeka valproat i povezanih tvari razvit i dostavit će edukacijske materijale sukladno dogovorenim ključnim elementima.
Bulgarian: Притежателите на разрешение за употреба на валпроат и лекарствените продукти, съдържащи валпроат трябва да разработят и представят образователни материали, съобразно договорените основни елементи.
Croatian: Ovi materijali trebaju osigurati informiranost propisivača te razumijevanje i prepoznavanje od strane bolesnika rizika povezanih s in-utero izlaganju valproatu.
Bulgarian: Тези материали трябва да гарантират, че предписващите лекари са информирани и пациентите разбират и съзнават рисковете, свързани с вътреутробната експозицията на валпроат.
Croatian: Nositelji odobrenja za stavljanje u promet lijeka valproat i povezanih tvari provest će ispitivanje iskoristivosti lijeka kako bi ocijenili djelotvornost mjera za smanjivanje rizika i dalje okarakterizirali obrasce propisivanja za valproat.
Bulgarian: Притежателите на разрешение за употреба на валпроат и лекарствени продукти, съдържащи валпроат трябва да извършат проучване на употребата на лекарството, за да се оцени ефективността на мерките за минимизиране на риска и за понататъшно характеризиране на моделите на предписване на валпроат.
Croatian: 11-15 Quai Dion Bouton 92800 Puteaux
Bulgarian: 11-15 Quai Dion Bouton 92800 Puteaux France
Croatian: National Highway 14568 Kryoneri Greece
Bulgarian: Highway 14568 Kryoneri Greece
Croatian: Luksemburg Eurogenerics SA Esplanade Heysel b22
Bulgarian: Люксембург Eurogenerics SA Esplanade Heysel b22
Croatian: A-1160, Wien
Bulgarian: A-1160, Wien Austria
Croatian: Njemačka Hexal Aktiengesellschaft Industriestr.
Bulgarian: Hexal Aktiengesellschaft Industriestr.
Croatian: DEMO ABEE 21st Km Athens-Lamias
Bulgarian: DEMO ABEE 21st Km Athens-Lamias National
Croatian: Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
Bulgarian: 6/2 LT-09310 Vilnius Lithuania
Croatian: 28230 Las Rozas (Madrid) Spain
Bulgarian: Oficina D 28230 Las Rozas (Madrid)
Croatian: 1099-036 Lisboa Portugal
Bulgarian: 1099-036 Lisboa
Croatian: 2700-487 Amadora Portugal
Bulgarian: 2700-487 Amadora
Croatian: 61118 Bad Vilbel
Bulgarian: 61118 Bad Vilbel Germany
Croatian: 90449 Nürnberg
Bulgarian: 90449 Nürnberg Germany
Croatian: Francuska Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Bulgarian: Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Croatian: Francuska Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Bulgarian: Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Croatian: PSC 170 00 Holesovice Czech Republic magnezijev valproat
Bulgarian: PSC 170 00 Holesovice Czech Republic
Croatian: Kampenringweg 45 D-E 2803 PE GOUDA
Bulgarian: Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Croatian: Francuska Biogaran 15, boulevard Charles de Gaulle
Bulgarian: 15, boulevard Charles de Gaulle
Croatian: Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Bulgarian: Латвия sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Croatian: 86156 Augsburg
Bulgarian: 86156 Augsburg Germany
Croatian: 1220 Wien Austria
Bulgarian: 1220 Wien
Croatian: Francuska Ranbaxy Pharmacie Génériques
Bulgarian: Ranbaxy Pharmacie Génériques
Croatian: Francuska SANDOZ 49, avenue Georges Pompidou
Bulgarian: 49, avenue Georges Pompidou
Croatian: Njemačka Stadapharm GmbH Stadastr 2-18
Bulgarian: Stadapharm GmbH Stadastr 2-18
Croatian: Luksemburg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Bulgarian: Люксембург Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Croatian: 02101 Espoo Finland
Bulgarian: 02101 Espoo
Croatian: Njemačka Mylan dura GmbH Wittichstr.
Bulgarian: Mylan dura GmbH Wittichstr.
Croatian: 40764 Langelfeld
Bulgarian: 23 40764 Langelfeld Germany
Croatian: DE-22335 Hamburg
Bulgarian: DE-22335 Hamburg Germany
Croatian: Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja u državama članicama
Bulgarian: Приложение I Списък на имената, лекарствени форми, количество на активното вещество в дозова единица, пътища на въвеждане на лекарстевните продукти, притежатели на разрешение за употреба в държавите членки
Croatian: Norton Healthcare Limited Ridings Point, Whistler Drive
Bulgarian: Ridings Point, Whistler Drive
Croatian: 83607 Hozkirchen
Bulgarian: 83607 Hozkirchen Germany
Croatian: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Bulgarian: Нидерландия Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Croatian: Winthrop Pharmaceuticals UK Limited
Bulgarian: Pharmaceuticals UK Limited
Croatian: Nizozemska Sanofi-Aventis Netherlands B.V.
Bulgarian: Нидерландия Sanofi-Aventis Netherlands B.V.
Croatian: Sanofi Malta Ltd St. Julian's Rd., San Gwann SGN 2805 Malta
Bulgarian: Julian's Rd., San Gwann SGN 2805 Malta
Croatian: Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany
Bulgarian: Weg beim Jaeger 214 DE-22335 Hamburg Germany
Croatian: Generis Farmacêutica, S.A. Rua João de Deus, 19 Amadora
Bulgarian: Rua João de Deus, 19
Croatian: 89150 Laichingen
Bulgarian: 19 89150 Laichingen Germany
Croatian: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Bulgarian: Remedica Ltd Aharnon Street Limassol Industrial Estate
Croatian: Rumunjska S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Bulgarian: S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31, Sector 2
Croatian: Bugarska Sanofi-Aventis Bulgaria EOOD
Bulgarian: Sanofi-Aventis Bulgaria EOOD
Croatian: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Italy
Bulgarian: 21040 Origgio (Varese) Italy
Croatian: Depakine sirup
Bulgarian: Depakine sirop
Croatian: 500-1000 mg granule s prilagođenim oslobađanjem
Bulgarian: 500-1000 mg Гранули с изменено освобождаване
Croatian: Austrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Bulgarian: Австрия sanofi-aventis GmbH SATURN Tower, Vienna DC
Croatian: Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
Bulgarian: Pärnu mnt 139E/2
Croatian: Swensweg 5 2031 GA HAARLEM The Netherlands
Bulgarian: Нидерландия Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Croatian: Sanofi Oy Huopalahdentie 24 PL 22
Bulgarian: Финландия Sanofi Oy Huopalahdentie 24
Croatian: Darwinweg 20 2333 CR LEIDEN The Netherlands
Bulgarian: Нидерландия Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN The Netherlands
Croatian: Depakine vloeistof voor kinderen, vloeistof voor oraal gebruik 300 mg/ml oralna tekućina
Bulgarian: Depakine vloeistof voor kinderen, vloeistof voor oraal gebruik 300 mg/ml
Croatian: Luksemburg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Bulgarian: Люксембург Mylan BVBA/SPRL Terhulpsesteenweg 6 box A
Croatian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Bulgarian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate
Croatian: 1000 Ljubljana
Bulgarian: 1000 Ľubľana Slovenia
Croatian: Sigma-Tau Industrie Farmaceutiche Riunite SpA Viale Shakespeare, 47 00144 Roma
Bulgarian: Viale Shakespeare, 47 00144 Roma Italy
Croatian: Hrvatska Sanofi-Aventis Croatia d.o.o.
Bulgarian: Sanofi-Aventis Croatia d.o.o.
Croatian: Njemačka ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Bulgarian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Croatian: sirup
Bulgarian: Сироп
Croatian: Francuska LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf
Bulgarian: LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf 91140 Villebon Sur Yvette
Croatian: C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Bulgarian: 5220 ODENSE SØ Denmark
Croatian: Depakine suikervrije stroop, drank 200 mg/5 ml oralna otopina
Bulgarian: Depakine suikervrije stroop, drank 200 mg/5 ml
Croatian: Valproinsäure- ratiopharm Lösung oralna otopina
Bulgarian: Valproinsäure- ratiopharm Lösung
Croatian: Sodium Valproate Tablets BP 500mg EC
Bulgarian: Натриев валпроат Таблеткаs BP 500mg EC
Croatian: VALPROATE DE SODIUM AGUETTANT 400 mg/4 ml, solution injectable otopina za injekciju u venu
Bulgarian: VALPROATE DE SODIUM AGUETTANT 400 mg/4 ml, solution injectable
Croatian: Benzstr.
Bulgarian: Brüningstr.
Croatian: Valpro TAD Lösung oralna otopina
Bulgarian: Valpro TAD Lösung
Croatian: Luksemburg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Bulgarian: Люксембург Takeda Belgium Chaussée de Gand 615
Croatian: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Bulgarian: Generics UK Limited Station Close, Potter's Bar
Croatian: Epilim 100 mg Crushable Tablets tableta
Bulgarian: Epilim 100 mg Crushable Таблеткаs
Croatian: Epilim 100mg Crushable Tablet tableta
Bulgarian: Epilim 100mg Crushable Таблетка
Croatian: 92931 Paris La Défense Cedex
Bulgarian: TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex
Croatian: Valprotek CR 300 mg (prolonged release) tablets
Bulgarian: Valprotek CR 300 mg (prolonged release) таблеткаs
Croatian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Belgium
Bulgarian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A
Croatian: Valprotek CR 500 mg (prolonged release) tablets
Bulgarian: Valprotek CR 500 mg (prolonged release) таблеткаs
Croatian: Depakine Chronosphere 250 166,76 mg + 72,61 mg granule s produljenim oslobađanjem
Bulgarian: Depakine Chronosphere 250 166.76 mg 72.61 mg
Croatian: Valproinsäure- ratiopharm 150 Filmtabletten
Bulgarian: Valproinsäure- ratiopharm 150 Filmтаблеткаten
Croatian: Epilim Enteric 200 mg gastroresistant coated tablets
Bulgarian: Epilim Enteric 200 mg gastroresistant coated таблеткаs
Croatian: kapsula, meka
Bulgarian: Мека капсула
Croatian: kapsula s produljenim oslobađanjem
Bulgarian: Капсула с удължено освобождаване
Croatian: Ges.m.b.H.
Bulgarian: GEROT PHARMAZEUTIKA Ges.m.b.H.
Croatian: Eastbourne, East Sussex BN 22 9AG
Bulgarian: Teva UK Limited Brampton Road, Hampden Park Eastbourne, East Sussex BN 22 9AG
Croatian: Epilim Enteric 500mg Gastroresistant Coated Tablets
Bulgarian: Epilim Enteric 500mg Gastroresistant Coated Таблеткаs
Croatian: Natrii valproas, maagsapresistente tabletten 300 mg
Bulgarian: Natrii valproas, maagsapresistente таблеткаten 300 mg
Croatian: Njemačka betapharm Arzneimittel GmbH
Bulgarian: betapharm Arzneimittel GmbH
Croatian: Njemačka Winthrop Arzneimittel GmbH
Bulgarian: Winthrop Arzneimittel GmbH
Croatian: Valproinsäure- ratiopharm 600 Filmtabletten
Bulgarian: Valproinsäure- ratiopharm 600 Filmтаблеткаten
Croatian: Depakine Enteric 150 mg 150 mg tablet
Bulgarian: Depakine Enteric 150 mg 150 mg
Croatian: Depakine Chrono 300 mg slow-release film-coated tablets
Bulgarian: Depakine Chrono 300 mg slow-release film-coated таблеткаs
Croatian: Valproat Aristo 300 mg magensaftresistente Filmtabletten
Bulgarian: Valproat Aristo 300 mg magensaftresistente Filmтаблеткаten
Croatian: Njemačka IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Bulgarian: IIP - Institut für industrielle
Croatian: Orlept (SF) Liquid or Sodium Valproate 40mg/ml oral solution oralna otopina
Bulgarian: Orlept (SF) Liquid or Натриев валпроат 40mg/ml Перорален разтвор
Croatian: Epilim Chrono 500mg Prolonged Release Tablets.
Bulgarian: Epilim Chrono 500mg Prolonged Release Таблеткаs.
Croatian: Depakine Chronosphere 1000 666,60 mg + 290,27 mg granule s produljenim oslobađanjem
Bulgarian: Depakine Chronosphere 1000 666,60 mg 290.27 mg
Croatian: Depakine Chronosphere 750 500,06 mg + 217,75 mg granule s produljenim oslobađanjem
Bulgarian: Depakine Chronosphere 750 500,06 mg 217,75 mg
Croatian: DEPAKINE 57,64 mg/ml, sirop 57,64 mg sirup
Bulgarian: DEPAKINE 57,64 mg/ml, sirop 57.64 mg
Croatian: Depakine Chronosphere 100 66,66 mg + 29,03 mg granule s produljenim oslobađanjem
Bulgarian: Depakine Chronosphere 100 66,66 mg 29.03 mg
Croatian: Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 Street
Bulgarian: Charalambou Mouskou 14 Street
Croatian: Depakine Chrono 500 mg slow-release film-coated tablets
Bulgarian: Depakine Chrono 500 mg slow-release film-coated таблеткаs
Croatian: Natriumvalproaat Apotex 300 mg/5 ml, drank oralna otopina
Bulgarian: Natriumvalproaat Apotex 300 mg/5 ml, drank
Croatian: Convulex 50 mg/ml - Sirup für Kinder sirup
Bulgarian: Convulex 50 mg/ml - Sirup für Kinder
Croatian: Valproat HEXAL 150mg Filmtabletten
Bulgarian: Valproat HEXAL 150mg Filmтаблеткаten
Croatian: Dipromal filmom obložena tableta
Bulgarian: Film-coated таблетка
Croatian: Epilim Chrono 200mg Prolonged Release Tablets
Bulgarian: Epilim Chrono 200mg Prolonged Release Таблеткаs
Croatian: 2a
Bulgarian: Benzstr. 2a
Croatian: Spain valpromid Depamide 300 mg comprimidos gastrorresistentes
Bulgarian: Валпромид Depamide 300 mg comprimidos gastrorresistentes
Croatian: Valproinsäure- ratiopharm 300 Filmtabletten
Bulgarian: Valproinsäure- ratiopharm 300 Filmтаблеткаten
Croatian: Njemačka Aristo Pharma GmbH Wallenroder Str. 8-10
Bulgarian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany
Croatian: Njemačka Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
Bulgarian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Croatian: Depakine chrono retard 300 mg Filmtabletten
Bulgarian: Depakine chrono retard 300 mg Filmтаблеткаten
Croatian: Natriumvalproat G.L. 500 mg - Retardtabletten
Bulgarian: Natriumvalproat G.L. 500 mg - Retardтаблеткаten
Croatian: oralne kapi, otopina kroz usta
Bulgarian: Перорални капки, разтвор
Croatian: CONVULEX 50 mg/ml szirup gyermekeknek sirup
Bulgarian: CONVULEX 50 mg/ml szirup gyermekeknek
Croatian: Valproat HEXAL 300mg/ml Lösung oralna otopina
Bulgarian: Valproat HEXAL 300mg/ml Lösung
Croatian: Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
Bulgarian: Avenida Professor Doutor Cavaco Silva, 10 E
Croatian: Absenor 500 mg prolonged release tablets
Bulgarian: Absenor 500 mg prolonged release таблеткаs
Croatian: Convulex Tropflösung oralna otopina
Bulgarian: Convulex Tropflösung
Croatian: Valproat chrono Desitin 500mg Retardtabletten
Bulgarian: Valproat chrono Desitin 500mg Retardтаблеткаten
Croatian: Depakin granule s prilagođenim oslobađanjem
Bulgarian: Гранули с изменено освобождаване
Croatian: Convulex retard 300 mg prolonged release tablets
Bulgarian: Convulex retard 300 mg prolonged release таблеткаs
Croatian: Epilim 400mg Powder & solvent for solution for injection prašak za injekciju u venu
Bulgarian: Epilim 400mg Powder & solvent for Инжекционен разтвор
Croatian: Depakine chrono retard 500 mg Filmtabletten
Bulgarian: Depakine chrono retard 500 mg Filmтаблеткаten
Croatian: Depakine Chronosphere 500 333,30 mg + 145,14 mg granule s produljenim oslobađanjem
Bulgarian: Depakine Chronosphere 500 333.30 mg 145,14 mg
Croatian: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Lagos Park, Edíficio 5A, Piso 2
Bulgarian: Lagos Park, Edíficio 5A, Piso 2
Croatian: Depakine 300 mg/ml Tropfen 300 mg/ml oralna otopina
Bulgarian: Depakine 300 mg/ml Tropfen 300 mg/ml
Croatian: Valproat chrono Desitin 300mg Retardtabletten
Bulgarian: Valproat chrono Desitin 300mg Retardтаблеткаten
Croatian: DEPAKINE 50 mg/ml szirup 50 mg/ml sirup
Bulgarian: DEPAKINE 50 mg/ml szirup 50 mg/ml
Croatian: Natriumvalproat G.L. 300 mg - Retardtabletten
Bulgarian: Natriumvalproat G.L. 300 mg - Retardтаблеткаten
Croatian: Delepsine tablet
Bulgarian: Обвита таблетка
Croatian: Epilim Chrono 300mg Prolonged Release Tablets
Bulgarian: Epilim Chrono 300mg Prolonged Release Таблеткаs
Croatian: Convulex 500 mgRetardtabletten
Bulgarian: Convulex 500 mgRetardтаблеткаten
Croatian: Orfiril CR 1000 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Bulgarian: Orfiril CR 1000 mg, granulaat met gereguleerde afgifte
Croatian: Depakine Chrono 500, tabletten met gereguleerde afgifte 500 mg tableta s prilagođenim oslobađanjem
Bulgarian: Depakine Chrono 500, таблеткаten met gereguleerde afgifte 500 mg
Croatian: Orfiril Injektionslösung otopina za injekciju u venu
Bulgarian: Orfiril Injektionslösung
Croatian: VALPROATE DE SODIUM ARROW 200 mg/ml, solution buvable oralna otopina
Bulgarian: VALPROATE DE SODIUM ARROW 200 mg/ml, solution buvable
Croatian: Convulex 300 mg/ml - Lösung zum Einnehmen oralna otopina
Bulgarian: Convulex 300 mg/ml - Lösung zum Einnehmen
Croatian: Convulex retard 500 mg prolonged release tablets
Bulgarian: Convulex retard 500 mg prolonged release таблеткаs
Croatian: France valpromid DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Bulgarian: Валпромид DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Croatian: Depakine 57,64 mg/ml syrup 57,64 mg/ml sirup
Bulgarian: Depakine 57,64 mg/ml Сироп 57.64 mg/ml
Croatian: 104 25 Stockholm Sweden valproatna kiselina natrijev valproat
Bulgarian: 104 25 Stockholm Sweden
Croatian: Orfiril CR 500 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Bulgarian: Orfiril CR 500 mg, granulaat met gereguleerde afgifte
Croatian: Natriumvalproaat Apotex 150 mg, maagsapresistente tabletten
Bulgarian: Natriumvalproaat Apotex 150 mg, maagsapresistente таблеткаten
Croatian: Valproat Heumann 150 mg magensaftresistente Tabletten
Bulgarian: Heumann 150 mg magensaftresistente Таблеткаten
Croatian: Depakine 300 mg/5 ml sirup
Bulgarian: Depakine 300 mg/5 ml
Croatian: Depakine Enteric, maagsapresistente tabletten 150 mg
Bulgarian: Depakine Enteric, maagsapresistente таблеткаten 150 mg
Croatian: Valproat HEXAL 600mg Filmtabletten
Bulgarian: Valproat HEXAL 600mg Filmтаблеткаten
Croatian: Depakine Chrono 300, tabletten met gereguleerde afgifte 300 mg tableta s prilagođenim oslobađanjem
Bulgarian: Depakine Chrono 300, таблеткаten met gereguleerde afgifte 300 mg
Croatian: Valproat STADA 300 mg Retardtabletten
Bulgarian: Valproat STADA 300 mg Retardтаблеткаten
Croatian: VALPROATE DE SODIUM ZENTIVA 200 mg/ml, solution buvable oralna otopina
Bulgarian: VALPROATE DE SODIUM ZENTIVA 200 mg/ml, solution buvable
Croatian: 92517 Boulogne Billancourt Cedex
Bulgarian: EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France
Croatian: Valproat Orion 300 mg Retardtabletten
Bulgarian: Valproat Orion 300 mg Retardтаблеткаten
Croatian: Depakine Enteric 300 mg 300 mg tablet
Bulgarian: Depakine Enteric 300 mg 300 mg
Croatian: Convulex 50 mg/ml syrup 50 mg/ml sirup
Bulgarian: Convulex 50 mg/ml syrup Конвулекс 50 mg/ml сироп
Croatian: Epilim Intravenous 400 mg, powder and solvent for solution for injection or infusion.
Bulgarian: Epilim Intravenous 400 mg, Прах и разтворител за инжекционен разтвор or infusion.
Croatian: Natriumvalproaat Chrono Sandoz 300 mg, tabletten met verlengde afgifte
Bulgarian: Natriumvalproaat Chrono Sandoz 300 mg, таблеткаten met verlengde afgifte
Croatian: Orfiril 100 mg/ml, oplossing voor injectie otopina za injekciju u venu
Bulgarian: Orfiril 100 mg/ml, oplossing voor injectie
Croatian: Valproat Orion 500 mg Retardtabletten
Bulgarian: Valproat Orion 500 mg Retardтаблеткаten
Croatian: Valpro beta chrono 500 mg Retardtabletten
Bulgarian: Valpro beta chrono 500 mg Retardтаблеткаten
Croatian: Convulex 150 mg kapsuly kapsula
Bulgarian: Convulex 150 mg kapsuly
Croatian: DEPAKINE 200 mg/ml, solution buvable oralna otopina
Bulgarian: DEPAKINE 200 mg/ml, solution buvable
Croatian: Natriumvalproaat Chrono Sandoz 500 mg, tabletten met verlengde afgifte
Bulgarian: Natriumvalproaat Chrono Sandoz 500 mg, таблеткаten met verlengde afgifte
Croatian: Natriumvalproaat Chrono CF 300 mg, tabletten met verlengde afgifte
Bulgarian: Natriumvalproaat Chrono CF 300 mg, таблеткаten met verlengde afgifte
Croatian: Convulex 300 mgRetardtabletten
Bulgarian: Convulex 300 mgRetardтаблеткаten
Croatian: DEPAKINE CHRONO 300 mg filmtabletta filmom obložena tableta
Bulgarian: DEPAKINE CHRONO 300 mg filmom obložene таблеткаe
Croatian: Convulex 300 mg kapsuly kapsula
Bulgarian: Convulex 300 mg kapsuly
Croatian: Valproat STADA 500 mg Retardtabletten
Bulgarian: Valproat STADA 500 mg Retardтаблеткаten
Croatian: 12 siječnja 2015.
Bulgarian: 12 януари 2015 г.
Croatian: Edukacijski se materijali trebaju dostaviti istovremeni s izmjenama primjene informacija o proizvodu.
Bulgarian: Образователните материали трябва да се подават едновременно със заявлението за изменение на информацията за продукта.
Croatian: Sastanak CMDh-a u studenom 2014.
Bulgarian: ноември 2014 среща на CMDh
Croatian: Raspored provedbe sporazuma
Bulgarian: График за прилагане на одобрението
Croatian: Implementacija sporazuma od strane država članica (dostavljanje izmjene za implementaciju izmjena u informacijama o proizvodu od strane nositelja odobrenja za stavljanje lijeka u promet):
Bulgarian: Прилагане на одобрението от страна на държавите членки (подаване на изменението за прилагане на промените в информацията за продукта от притежателя на разрешението за употреба):
Croatian: Prosljeđivanje prijevoda dodatka sporazumu nadležnim nacionalnim tijelima:
Bulgarian: Предаване на преводите на приложенията към споразумението на националните компетентни органи:
Croatian: Dodatak V. Raspored provedbe sporazuma
Bulgarian: Приложение V График за прилагане на одобрението
Croatian: 17. travnja 2019.
Bulgarian: 17 април 2019 г.
Croatian: Istraživanje se nastavlja
Bulgarian: Изследването продължава
Croatian: EMA/248364/2019 Rev1
Bulgarian: EMA/248364/2019, рев. 1
Croatian: Djelatna tvar (maksimalna dnevna doza)
Bulgarian: Активно вещество (максимална дневна доза)
Croatian: • Imate li pitanja u vezi s lijekom koji uzimate ili koji ste uzimali u prošlosti, obratite se svojem liječniku ili ljekarniku.
Bulgarian: Ако имате някакви въпроси относно Вашето лекарство или лекарство, което сте приемали в миналото, говорете с Вашия лекар или фармацевт.
Croatian: Nakon ispitivanja neki su lijekovi povučeni iz ljekarni i više se ne upotrebljavaju u EU-u.
Bulgarian: След изследвания някои лекарства са изтеглени от аптеките и вече не се използват в ЕС.
Croatian: Ispitivanje tijekom i nakon prijelaznog razdoblja
Bulgarian: Изследване по време на преходния период и след него
Croatian: 2 Smjernice Međunarodnog vijeća za harmonizaciju tehničkih zahtjeva za farmaceutske proizvode za primjenu u ljudi (ICH): M7(R1)
Bulgarian: Насоки на Международния съвет за хармонизация на техническите изисквания за лекарствени продукти за хуманна употреба (ICH): M7(R1)
Croatian: Možete se obratiti i svojem nacionalnom tijelu nadležnom za lijekove.
Bulgarian: Можете също така да се свържете с Вашия национален лекарствен орган.
Croatian: Procjene su ekstrapolirane iz ispitivanja provedenih na životinjama i vrlo su niske u usporedbi s rizikom od raka tijekom života u EU-u (u 1 na 2 slučaja).
Bulgarian: Оценките са екстраполирани от проучвания върху животни и са много ниски в сравнение с доживотния риск от рак в целия ЕС (1 на 2).
Croatian: • U slučaju potrebe za dodatnim opozivima ili drugim mjerama, nacionalna tijela obavijestit će vas o mjerama koje trebate poduzeti.
Bulgarian: Ако има нужда от по-нататъшни изтегляния или други мерки, националните органи ще Ви информират за действията, които трябва да се предприемат.
Croatian: Ocjenjivanje lijekova koji sadržavaju valsartan pokrenuto je 5. srpnja 2018. na zahtjev Europske komisije u skladu s člankom 31. Direktive 2001/83/EZ.
Bulgarian: Прегледът на лекарствата, съдържащи валсартан, е започнат от Европейската комисия на 5 юли 2018 г. съгласно член 31 на Директива 2001/83/ЕО.