FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Frankrig Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Bulgarian: Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Danish: Kampenringweg 45 D-E 2803 PE GOUDA
Bulgarian: Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Danish: 08019 Barcelona
Bulgarian: 08019 Barcelona Spain
Danish: 86156 Augsburg
Bulgarian: 86156 Augsburg Germany
Danish: Frankrig Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Bulgarian: Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Danish: Tyskland Mylan dura GmbH Wittichstr.
Bulgarian: Mylan dura GmbH Wittichstr.
Danish: Frankrig Biogaran 15, boulevard Charles de Gaulle
Bulgarian: 15, boulevard Charles de Gaulle
Danish: Danmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Bulgarian: Edvard Thomsens Vej 14 DK-2300 København S Denmark
Danish: LT-09310 Vilnius
Bulgarian: 6/2 LT-09310 Vilnius Lithuania
Danish: Frankrig SANDOZ 49, avenue Georges Pompidou
Bulgarian: 49, avenue Georges Pompidou
Danish: Rumænien GEROT PHARMAZEUTIKA Ges.m.b.H.
Bulgarian: GEROT PHARMAZEUTIKA Ges.m.b.H.
Danish: Tyskland Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Bulgarian: Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Danish: Frankrig Ranbaxy Pharmacie Génériques
Bulgarian: Ranbaxy Pharmacie Génériques
Danish: 1220 Wien Austria
Bulgarian: 1220 Wien
Danish: Tyskland Stadapharm GmbH Stadastr 2-18
Bulgarian: Stadapharm GmbH Stadastr 2-18
Danish: Luxembourg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Bulgarian: Люксембург Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Danish: 40764 Langelfeld
Bulgarian: 23 40764 Langelfeld Germany
Danish: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Bulgarian: S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31, Sector 2
Danish: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Bulgarian: Нидерландия Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Danish: Litauen UAB „SANOFI-AVENTIS LIETUVA"
Bulgarian: UAB „SANOFI-AVENTIS LIETUVA"
Danish: Danmark Sanofi-aventis Denmark A/S
Bulgarian: Sanofi-aventis Denmark A/S
Danish: Winthrop Pharmaceuticals UK Limited
Bulgarian: Pharmaceuticals UK Limited
Danish: 83607 Hozkirchen
Bulgarian: 83607 Hozkirchen Germany
Danish: Evropská 846/176a 160 00 Prague 6
Bulgarian: Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Prague 6
Danish: Norton Healthcare Limited Ridings Point, Whistler Drive
Bulgarian: Ridings Point, Whistler Drive
Danish: 500-1000 mg Granulat med modificeret udløsning
Bulgarian: 500-1000 mg Гранули с изменено освобождаване
Danish: Sanofi Malta Ltd St. Julian's Rd., San Gwann SGN 2805 Malta
Bulgarian: Julian's Rd., San Gwann SGN 2805 Malta
Danish: 1080 Brussels
Bulgarian: 1080 Bruxelles
Danish: DE-22335 Hamburg
Bulgarian: DE-22335 Hamburg Germany
Danish: Spanien Genfarma Laboratorio, S.L.
Bulgarian: Genfarma Laboratorio, S.L.
Danish: Finland Sanofi Oy Huopalahdentie 24 PL 22
Bulgarian: Финландия Sanofi Oy Huopalahdentie 24
Danish: Letland sanofi-aventis Latvia SIA Kr.Valdemara 33-8
Bulgarian: Латвия sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Danish: Holland Sanofi-Aventis Netherlands B.V.
Bulgarian: Нидерландия Sanofi-Aventis Netherlands B.V.
Danish: Generis Farmacêutica, S.A. Rua João de Deus, 19 Amadora
Bulgarian: Rua João de Deus, 19
Danish: 89150 Laichingen
Bulgarian: 19 89150 Laichingen Germany
Danish: Bulgarien Sanofi-Aventis Bulgaria EOOD
Bulgarian: Sanofi-Aventis Bulgaria EOOD
Danish: Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany
Bulgarian: Weg beim Jaeger 214 DE-22335 Hamburg Germany
Danish: Belgien Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Bulgarian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Belgium
Danish: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Italy
Bulgarian: 21040 Origgio (Varese) Italy
Danish: Østrig sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Bulgarian: Австрия sanofi-aventis GmbH SATURN Tower, Vienna DC
Danish: Cypern Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Bulgarian: Remedica Ltd Aharnon Street Limassol Industrial Estate
Danish: Swensweg 5 2031 GA HAARLEM The Netherlands
Bulgarian: Нидерландия Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Danish: Holland Sandoz B.V.
Bulgarian: Нидерландия Sandoz B.V.
Danish: Darwinweg 20 2333 CR LEIDEN The Netherlands
Bulgarian: Нидерландия Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN The Netherlands
Danish: Luxembourg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Bulgarian: Люксембург Mylan BVBA/SPRL Terhulpsesteenweg 6 box A
Danish: Frankrig EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou
Bulgarian: EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France
Danish: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Bulgarian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate
Danish: 400, poeder voor injectievloeistof 400 mg
Bulgarian: 400, poeder voor injectievloeistof
Danish: Sigma-Tau Industrie Farmaceutiche Riunite SpA Viale Shakespeare, 47 00144 Roma
Bulgarian: Viale Shakespeare, 47 00144 Roma Italy
Danish: Depakine Chrono 300, tabletten met gereguleerde afgifte 300 mg
Bulgarian: Depakine Chrono 300, таблеткаten met gereguleerde afgifte 300 mg
Danish: Valpromid Depamide
Bulgarian: Валпромид Depamide
Danish: Depakine Chrono 500, tabletten met gereguleerde afgifte 500 mg
Bulgarian: Depakine Chrono 500, таблеткаten met gereguleerde afgifte 500 mg
Danish: Valproinsyre Ácido Valpróico Generis
Bulgarian: Ácido Valpróico Generis
Danish: 17 Bonifraterska Str. 00-203 Warsaw Poland
Bulgarian: Sanofi-Aventis Sp. z o.o. 17 Bonifraterska Str. 00-203 Warsaw Poland
Danish: Valproinsyre VALPROATE SODIUM SANDOZ 500MG
Bulgarian: VALPROATE SODIUM SANDOZ 500MG
Danish: Luxembourg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Bulgarian: Takeda Belgium Gentsesteenweg 615 1080 Brussels Belgium
Danish: Kapsel, hård
Bulgarian: Твърда капсула
Danish: Frankrig 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
Danish: Estland Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
Bulgarian: Pärnu mnt 139E/2
Danish: Sodium Valproate Tablets BP 500mg EC
Bulgarian: Натриев валпроат Таблеткаs BP 500mg EC
Danish: Tyskland ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Bulgarian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Danish: Epilim 100 mg Crushable Tablets
Bulgarian: Epilim 100 mg Crushable Таблеткаs
Danish: Epilim 100mg Crushable Tablet
Bulgarian: Epilim 100mg Crushable Таблетка
Danish: Orlept (SF) Liquid or Sodium Valproate 40mg/ml oral solution
Bulgarian: Orlept (SF) Liquid or Натриев валпроат 40mg/ml Перорален разтвор
Danish: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Bulgarian: Generics UK Limited Station Close, Potter's Bar
Danish: SI-1000 Ljubljana Slovenia
Bulgarian: Verovškova 57 SI-1000 Ljubljana Slovenia
Danish: Belgien Takeda Belgium Gentsesteenweg 615
Bulgarian: Люксембург Takeda Belgium Chaussée de Gand 615
Danish: Granulat med modificeret udløsning
Bulgarian: Гранули с изменено освобождаване
Danish: Dunajska cesta 151
Bulgarian: Dunajska cesta 151 1000 Ljubljana Slovenia
Danish: Seminatrium valproat
Bulgarian: Семинатриев валпроат
Danish: Epilim 400mg Powder & solvent for solution for injection
Bulgarian: Epilim 400mg Powder & solvent for Инжекционен разтвор
Danish: Valprotek CR 300 mg (prolonged release) tablets
Bulgarian: Valprotek CR 300 mg (prolonged release) таблеткаs
Danish: Grækenland DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Greece
Bulgarian: Highway 14568 Kryoneri Greece
Danish: 92931 Paris La Défense Cedex
Bulgarian: TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex
Danish: Tyskland IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Bulgarian: IIP - Institut für industrielle
Danish: Valprotek CR 500 mg (prolonged release) tablets
Bulgarian: Valprotek CR 500 mg (prolonged release) таблеткаs
Danish: Valproinsyre DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Bulgarian: DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Danish: Epilim Enteric 200 mg gastroresistant coated tablets
Bulgarian: Epilim Enteric 200 mg gastroresistant coated таблеткаs
Danish: Valproinsäure- ratiopharm 150 Filmtabletten
Bulgarian: Valproinsäure- ratiopharm 150 Filmтаблеткаten
Danish: Belgien Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Bulgarian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A
Danish: Kapsel med modificeret udløsning, hård
Bulgarian: Твърда капсула с изменено освобождаване
Danish: Finland Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Bulgarian: Финландия Sandoz A/S C. F. Tietgens Boulevard
Danish: Kroatien Sanofi-Aventis Croatia d.o.o.
Bulgarian: Sanofi-Aventis Croatia d.o.o.
Danish: Convulex 100 mg/ml solution for injection/concentrate for solution for infusion
Bulgarian: Convulex 100 mg/ml Инжекционен разтвор/concentrate for solution for infusion
Danish: Sanofi-aventis Ireland Ltd. T/A SANOFI
Bulgarian: Sanofi-aventis Ireland Ltd. T/A SANOFI Citywest Business Campus
Danish: Eastbourne, East Sussex BN 22 9AG
Bulgarian: Teva UK Limited Brampton Road, Hampden Park Eastbourne, East Sussex BN 22 9AG
Danish: Epilim Enteric 500mg Gastroresistant Coated Tablets
Bulgarian: Epilim Enteric 500mg Gastroresistant Coated Таблеткаs
Danish: Valproinsyre Diplexil 1000
Bulgarian: Diplexil 1000
Danish: Natrii valproas, maagsapresistente tabletten 300 mg
Bulgarian: Natrii valproas, maagsapresistente таблеткаten 300 mg
Danish: Tyskland Winthrop Arzneimittel GmbH
Bulgarian: Winthrop Arzneimittel GmbH
Danish: Valproinsyre CONVULEX 50 mg/ml szirup gyermekeknek
Bulgarian: CONVULEX 50 mg/ml szirup gyermekeknek
Danish: 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.
Danish: Tyskland betapharm Arzneimittel GmbH
Bulgarian: betapharm Arzneimittel GmbH
Danish: Valproat Aristo 300 mg magensaftresistente Filmtabletten
Bulgarian: Valproat Aristo 300 mg magensaftresistente Filmтаблеткаten
Danish: Calcium divalproate
Bulgarian: Калциев дивалпроат
Danish: Valpromid Depamide 300 mg comprimidos gastrorresistentes
Bulgarian: Валпромид Depamide 300 mg comprimidos gastrorresistentes
Danish: Epilim Chrono 500mg Prolonged Release Tablets.
Bulgarian: Epilim Chrono 500mg Prolonged Release Таблеткаs.
Danish: Depakine Chrono 300 mg slow-release film-coated tablets
Bulgarian: Depakine Chrono 300 mg slow-release film-coated таблеткаs
Danish: Valproinsäure- ratiopharm 600 Filmtabletten
Bulgarian: Valproinsäure- ratiopharm 600 Filmтаблеткаten
Danish: 2a
Bulgarian: Benzstr. 2a
Danish: Tyskland Aristo Pharma GmbH Wallenroder Str. 8-10
Bulgarian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany
Danish: Depakine Chrono 500 mg slow-release film-coated tablets
Bulgarian: Depakine Chrono 500 mg slow-release film-coated таблеткаs
Danish: Valproinsyre CONVULEX 100 mg/ml oldatos injekció
Bulgarian: CONVULEX 100 mg/ml oldatos injekció
Danish: Tyskland Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Bulgarian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Danish: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Lagos Park, Edíficio 5A, Piso 2
Bulgarian: Lagos Park, Edíficio 5A, Piso 2
Danish: Absenor 500 mg prolonged release tablets
Bulgarian: Absenor 500 mg prolonged release таблеткаs
Danish: Valproat HEXAL 150mg Filmtabletten
Bulgarian: Valproat HEXAL 150mg Filmтаблеткаten
Danish: Valpromid DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Bulgarian: Валпромид DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Danish: Depakine 57,64 mg/ml syrup 57,64 mg/ml
Bulgarian: Depakine 57,64 mg/ml Сироп 57.64 mg/ml
Danish: Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
Bulgarian: Avenida Professor Doutor Cavaco Silva, 10 E
Danish: Epilim Syrup 200mg/5ml
Bulgarian: Epilim Сироп 200mg/5ml
Danish: Valproinsyre Convulex 300 mg - Kapseln 300 mg
Bulgarian: Convulex 300 mg - Kapseln 300 mg
Danish: Valproinsäure- ratiopharm 300 Filmtabletten
Bulgarian: Valproinsäure- ratiopharm 300 Filmтаблеткаten
Danish: Valproinsyre Convulex 50 mg/ml - Sirup für Kinder
Bulgarian: Convulex 50 mg/ml - Sirup für Kinder
Danish: Valproat chrono Desitin 500mg Retardtabletten
Bulgarian: Valproat chrono Desitin 500mg Retardтаблеткаten
Danish: Convulex retard 300 mg prolonged release tablets
Bulgarian: Convulex retard 300 mg prolonged release таблеткаs
Danish: Epilim 200 Gastro Resistant Tablets
Bulgarian: Epilim 200 Gastro Resistant Таблеткаs
Danish: Epilim 500 Gastro resistant tablets
Bulgarian: Epilim 500 Gastro resistant таблеткаs
Danish: Convulex 50 mg/ml syrup 50 mg/ml
Bulgarian: Convulex 50 mg/ml Сироп 50 mg/ml
Danish: Convulex 300 mg/mlLösung zum Einnehmen
Bulgarian: Convulex 300 mg/ml - Lösung zum Einnehmen
Danish: Valproinsyre Valproat "Sandoz"
Bulgarian: Valproat "Sandoz"
Danish: Cypern Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14
Bulgarian: Sanofi-Aventis Cyprus Ltd
Danish: Epilim Chrono 200mg Prolonged Release Tablets
Bulgarian: Epilim Chrono 200mg Prolonged Release Таблеткаs
Danish: Valproat chrono Desitin 300mg Retardtabletten
Bulgarian: Valproat chrono Desitin 300mg Retardтаблеткаten
Danish: Rektal anvendelse
Bulgarian: Rectal use
Danish: Episenta 150mg Prolongedrelease capsules
Bulgarian: Episenta 150mg Капсула с удължено освобождаванеs
Danish: Tablet, filmovertrukket
Bulgarian: Film-coated таблетка
Danish: Convulex 500 mgRetardtabletten
Bulgarian: Convulex 500 mgRetardтаблеткаten
Danish: Valproinsyre Convulex 150 mg - Kapseln 150 mg
Bulgarian: Convulex 150 mg - Kapseln 150 mg
Danish: Valproinsyre Convulex 500 mg - Kapseln 500 mg
Bulgarian: Convulex 500 mg - Kapseln 500 mg
Danish: Convulex retard 500 mg prolonged release tablets
Bulgarian: Convulex retard 500 mg prolonged release таблеткаs
Danish: Tyskland 1 A Pharma GmbH Keltenring 1 + 3
Bulgarian: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Danish: Natriumvalproaat chrono 300 mg Teva, tabletten met gereguleerde afgifte
Bulgarian: Natriumvalproaat chrono 300 mg Teva, таблеткаten met gereguleerde afgifte
Danish: Valproat Heumann 150 mg magensaftresistente Tabletten
Bulgarian: Heumann 150 mg magensaftresistente Таблеткаten
Danish: Epilim Chrono 300mg Prolonged Release Tablets
Bulgarian: Epilim Chrono 300mg Prolonged Release Таблеткаs
Danish: Sodium valproate liquid 200mg/5ml
Bulgarian: Натриев валпроат liquid 200mg/5ml
Danish: Natriumvalproaat chrono 500 mg Teva, tabletten met gereguleerde afgifte
Bulgarian: Natriumvalproaat chrono 500 mg Teva, таблеткаten met gereguleerde afgifte
Danish: Valproinsyre Convulex gelule gastro résistante
Bulgarian: gelule gastro résistante
Danish: Depakine Enteric, maagsapresistente tabletten 150 mg
Bulgarian: Depakine Enteric, maagsapresistente таблеткаten 150 mg
Danish: DEPAKINE CHRONO 300 mg filmom obložene tablete
Bulgarian: DEPAKINE CHRONO 300 mg filmom obložene таблеткаe
Danish: Valproat HEXAL 600mg Filmtabletten
Bulgarian: Valproat HEXAL 600mg Filmтаблеткаten
Danish: D-22311 HAMBURG Deutschland
Bulgarian: Postfach 630164 D-22311 HAMBURG Deutschland
Danish: Valproat STADA 300 mg Retardtabletten
Bulgarian: Valproat STADA 300 mg Retardтаблеткаten
Danish: Natriumvalproaat Apotex 150 mg, maagsapresistente tabletten
Bulgarian: Natriumvalproaat Apotex 150 mg, maagsapresistente таблеткаten
Danish: Valproat Orion 300 mg Retardtabletten
Bulgarian: Valproat Orion 300 mg Retardтаблеткаten
Danish: Valproinsyre Convulex 100 mg/mlInjektionslösung
Bulgarian: Convulex 100 mg/mlInjektionslösung
Danish: Epilim Chrono 500mg Controlled Release Tablets
Bulgarian: Epilim Chrono 500mg Controlled Release Таблеткаs
Danish: Valproinsyre CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Bulgarian: CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Danish: Convulsofin Tabletten
Bulgarian: Обвита таблетка
Danish: Natriumvalproaat Chrono Sandoz 300 mg, tabletten met verlengde afgifte
Bulgarian: Natriumvalproaat Chrono Sandoz 300 mg, таблеткаten met verlengde afgifte
Danish: Valproat Orion 500 mg Retardtabletten
Bulgarian: Valproat Orion 500 mg Retardтаблеткаten
Danish: Valpro beta chrono 500 mg Retardtabletten
Bulgarian: Valpro beta chrono 500 mg Retardтаблеткаten
Danish: 13435 Berlin espa-valept 300 mg retard 199,8 mg, 87 mg
Bulgarian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany espa-valept 300 mg retard 199.8 mg, 87 mg
Danish: Natriumvalproaat Chrono Sandoz 500 mg, tabletten met verlengde afgifte
Bulgarian: Natriumvalproaat Chrono Sandoz 500 mg, таблеткаten met verlengde afgifte
Danish: Convulex 300 mgRetardtabletten
Bulgarian: Convulex 300 mgRetardтаблеткаten
Danish: Valproat STADA 500 mg Retardtabletten
Bulgarian: Valproat STADA 500 mg Retardтаблеткаten
Danish: Depakine chrono retard 300 mg Filmtabletten
Bulgarian: Depakine chrono retard 300 mg Filmтаблеткаten
Danish: Den 12. januar 2015
Bulgarian: 12 януари 2015 г.
Danish: Oplysningsmaterialet skal indsendes på samme tidspunkt som ansøgningen om ændring af produktinformationen.
Bulgarian: Образователните материали трябва да се подават едновременно със заявлението за изменение на информацията за продукта.
Danish: Aftalen gennemføres i medlemsstaterne (indsendelse af ændringsansøgningen med henblik på gennemførelse af de ændringer, markedsføringstilladelsesindehaveren har foretaget i produktinformationen):
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):
Danish: Tidsplan for gennemførelse af aftalen
Bulgarian: График за прилагане на одобрението
Danish: CMD(h)'s møde i november 2014
Bulgarian: ноември 2014 среща на CMDh
Danish: Bilag V Tidsplan for gennemførelse af aftalen
Bulgarian: Приложение V График за прилагане на одобрението
Danish: Vedtagelse af CMD(h)-aftalen:
Bulgarian: Приемане на съгласието на CMDh:
Danish: Undersøgelser under og efter overgangsperioden
Bulgarian: Изследване по време на преходния период и след него
Danish: • Hvis der er behov for yderligere tilbagekaldelser eller andre foranstaltninger, vil de nationale myndigheder informere dig om, hvad der skal gøres.
Bulgarian: Ако има нужда от по-нататъшни изтегляния или други мерки, националните органи ще Ви информират за действията, които трябва да се предприемат.
Danish: Aktivt stof (maksimal daglig dosis)
Bulgarian: Активно вещество (максимална дневна доза)
Danish: En vurderingsrapport med yderligere oplysninger om gennemgangen er offentliggjort på EMA's websted.
Bulgarian: Оценъчен доклад с повече подробности за прегледа е публикуван на уебсайта на ЕМА.
Danish: Undersøgelserne fortsætter
Bulgarian: Изследването продължава
Danish: 2 Vejledning fra International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH): M7(R1)
Bulgarian: Насоки на Международния съвет за хармонизация на техническите изисквания за лекарствени продукти за хуманна употреба (ICH): M7(R1)
Danish: Estimaterne er ekstrapoleret fra dyrestudier og er meget lave sammenholdt med livstidsrisikoen for kræft i EU (1 ud af 2).
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).
Danish: Du kan også kontakte de danske lægemiddelmyndigheder.
Bulgarian: Можете също така да се свържете с Вашия национален лекарствен орган.
Danish: Efter en række undersøgelser er nogle lægemidler blevet tilbagekaldt fra apoteker og anvendes ikke længere i EU.
Bulgarian: След изследвания някои лекарства са изтеглени от аптеките и вече не се използват в ЕС.
Danish: Gennemgangen af valsartan-lægemidler blev indledt den 5. juli 2018 på anmodning fra EuropaKommissionen i henhold til artikel 31 i direktiv 2001/83/EC.
Bulgarian: Прегледът на лекарствата, съдържащи валсартан, е започнат от Европейската комисия на 5 юли 2018 г. съгласно член 31 на Директива 2001/83/ЕО.
Danish: NDEA i disse lægemidler kan medføre 8 ekstra tilfælde pr. 100.000 patienter, der tager medicinen ved den højeste dosis dagligt i 4 år.1
Bulgarian: NDEA в тези лекарства може да доведе до 8 допълнителни случая при 100 000 пациенти, приемащи лекарството в най-високата доза всеки ден в продължение на 4 години.1
Danish: 17. april 2019 EMA/248364/2019 Rev 1
Bulgarian: EMA/248364/2019, рев. 1
Danish: • Hvis du har spørgsmål om et lægemiddel, som du aktuelt tager, eller som du tidligere har taget, kan du tale med lægen eller apotekspersonalet.
Bulgarian: Ако имате някакви въпроси относно Вашето лекарство или лекарство, което сте приемали в миналото, говорете с Вашия лекар или фармацевт.
Danish: EMA's anbefalinger vedrørende NDMA og NDEA blev sendt til Europa-Kommissionen, der traf juridisk bindende afgørelser.
Bulgarian: Препоръките на EMA за NDMA и NDEA са изпратени до Европейската комисия, която издава правно обвързващи решения.
Danish: Myndighederne i EU vil også bruge erfaringen fra denne gennemgang til at forbedre den måde, som urenheder i lægemidler opdages og håndteres på.
Bulgarian: Органите в ЕС ще вземат също предвид поуките, които могат да бъдат извлечени от този преглед, за да се подобри начинът, по който се идентифицират и обработват примесите в лекарствата.
Danish: Grænseværdierne er baseret på det maksimale daglige indtag for hver urenhed i dyrestudier:
Bulgarian: Границите се основават на максималния дневен прием за всеки примес, получен от проучвания върху животни:
Danish: 96,0 nanogram for NDMA og 26,5 nanogram for NDEA.
Bulgarian: 96,0 нанограма за NDMA и 26,5 нанограма за NDEA.
Danish: Gennemgangen skønnede den højest mulige kræftrisiko med disse urenheder.
Bulgarian: Прегледът оценява най-високия възможен риск от рак при тези примеси.
Danish: Virksomhederne skal nu træffe foranstaltninger for at undgå tilstedeværelsen af urenhederne og gennemføre grundige undersøgelser af deres produkter.
Bulgarian: Сега фирмите трябва да предприемат мерки за избягване на наличието на тези примеси и да извършват щателно изследване на продуктите си.
Danish: Candesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg)
Bulgarian: Candesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg)
Danish: Disse lægemidler anvendes til at behandle patienter med forhøjet blodtryk (hypertension) og patienter med visse hjerte- eller nyresygdomme.
Bulgarian: Тези лекарства се използват за лечение на пациенти с хипертония (високо кръвно налягане) и такива с определени сърдечни или бъбречни заболявания.
Danish: Efter denne periode skal virksomhederne dokumentere, at deres sartanprodukter ikke har målbare niveauer af urenhederne, før de kan bruges i EU.
Bulgarian: След този период фирмите ще трябва да докажат, че техните лекарствени продукти, съдържащи сартани, нямат количествено измерими нива на тези примеси, преди те да могат да бъдат използвани в ЕС.
Danish: CHMP's udtalelse blev sendt til Europa-Kommissionen, der traf juridisk bindende afgørelser med gyldighed i alle EU's medlemsstater for de berørte lægemidler mellem den 2. april og den 17. april
Bulgarian: Становището на CHMP е предадено на Европейската комисия, която издава окончателни правнообвързващи решения за съответните лекарства между 2 април и 17 април 2019 г., които са приложими във всички държави - членки на ЕС.
Danish: Gennemgangen blev foretaget af EMA's udvalg for humanmedicinske lægemidler (CHMP), der har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets udtalelse.
Bulgarian: Прегледът е извършен от Комитета по лекарствените продукти за хуманна употреба (CHMP) на EMA, отговарящ за въпросите, свързани с лекарствата за хуманна употреба, който приема становището на Агенцията.
Danish: Efter overgangsperioden skal virksomhederne sikre, at der er endnu lavere niveauer af NDEA eller NDMA i deres produkter (færre end 0,03 ppm).
Bulgarian: След преходния период фирмите трябва да изключат наличието дори на още по-ниски нива на NDEA или NDMA в продуктите си (< 0,03 части на милион).