FrancophonIA/ELRC3.0 huggingface dataset:
Bulgarian: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria бозентан
Latvian: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria bosentāna
Bulgarian: Триметазидин Energotrim
Latvian: Energotrim
Bulgarian: Деслоратадин Desloratadine/Genepharm 5 mg δισκία επικαλυμμένα με υμένιο,
Latvian: Desloratadine/Genephar m 5 mg δισκία επικαλυμμένα με υμένιο,
Bulgarian: Трамадол/параце тамол
Latvian: Tramadols/ paracetamols
Bulgarian: Irbesartan HCTZ Fair-Med 300+25 mg Filmtabletten
Latvian: Irbesartan HCTZ FairMed 300+25 mg Filmtabletten
Bulgarian: Wörwag Pharma GmbH & Co. KG
Latvian: Wörwag Pharma GmbH & Co.
Bulgarian: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide
Latvian: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide 2790-012 Portela de Carnaxide
Bulgarian: João II, Lote 1.06.2.2 C - 7.3 e 7.4
Latvian: João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal
Bulgarian: Ципрофлоксацин Ciprofloxacin Fair-Med Coated Tablets
Latvian: Ciprofloxacin Fair-Med Coated Tablets
Bulgarian: Grange Road Dublin 13
Latvian: Grange Road
Bulgarian: Valsartan/hydrochlorthiazi d "Fair-Med"
Latvian: Valsartan/hydrochlorthi azid "Fair-Med"
Bulgarian: Великобритания Fannin (UK) Ltd 42-46 Booth Drive Park Farm South
Latvian: Lielbritānija Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Bulgarian: Rua Henrique Paiva Couceiro, 29 - Venda Nova
Latvian: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal nebivolol
Bulgarian: H-6724 Szeged Cserzy Mihály u. 32.
Latvian: Goodwill Pharma Kft. H-6724 Szeged Cserzy Mihály u.
Bulgarian: Деслоратадин Desloratadine Labormed 2.5 mg comprimate orodispersabile
Latvian: Desloratadine Labormed 2.5 mg comprimate orodispersabile
Bulgarian: Деслоратадин Inaller 5 mg filmtabletta 5 mg
Latvian: Inaller 5 mg filmtabletta 5 mg
Bulgarian: Sandoz B.V.
Latvian: Nīderlande Sandoz B.V.
Bulgarian: Adamed Sp. z o.o. Pieńków
Latvian: Adamed Sp. z o.o.
Bulgarian: Brown & Burk UK, Ltd. 5, Marryat Close Hounslow
Latvian: 5, Marryat Close Hounslow
Bulgarian: Кандесартан цилексетил
Latvian: Kandesartāna cileksetils
Bulgarian: Veluwezoom 22 1327 AH Almere The Netherlands
Latvian: 1327 AH Almere The Netherlands
Bulgarian: Великобритания Fair-Med Healthcare GmbH Planckstrasse 13
Latvian: Lielbritānija Fair-Med Healthcare GmbH Planckstrasse 13
Bulgarian: Деслоратадин Desloratadina Peseri
Latvian: Desloratadina Peseri
Bulgarian: SE-11123 Stockholm Sweden венлафаксин хидрохлорид
Latvian: SE-11123 Stockholm Sweden venlafaksīns hidrohlorīds
Bulgarian: Деслоратадин Desloratadine Teva
Latvian: Desloratadine Teva
Bulgarian: Austria небиволол
Latvian: Austria nebivolol
Bulgarian: Цефподоксим Cefpodoxima Alkaloid 200 mg таблетка
Latvian: Cefpodoxima Alkaloid 200 mg Tablete
Bulgarian: Lambda Therapeutic Limited
Latvian: Lambda Therapeutic Limited Sage House
Bulgarian: SE-11123 Stockholm Sweden венлафаксин
Latvian: SE-11123 Stockholm Sweden venlafaksīns
Bulgarian: Деслоратадин Alvotadin 2.5 mg szájban diszpergálódó tabletta
Latvian: Alvotadin 2.5 mg szájban diszpergálódó tabletta
Bulgarian: Via Rossellini Ippolito, 12 20124 Milan
Latvian: Pensa Pharma S.P.A. Via Rossellini Ippolito, 12 20124 Milan
Bulgarian: Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº
Latvian: Edíficio Arquiparque 1, R/C Esqº
Bulgarian: Триметазидин Trimetazidina Mylan 35 mg comprimate filmate cu eliberare prelungita
Latvian: Trimetazidina Mylan 35 mg comprimate filmate cu eliberare prelungita
Bulgarian: RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain небиволол
Latvian: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid)
Bulgarian: Финландия Bluefish Pharmaceuticals AB Torsgatan 11
Latvian: Lielbritānija Bluefish Pharmaceuticals AB Torsgatan 11
Bulgarian: Slovenia бозентан
Latvian: Slovenia bosentāna
Bulgarian: Irbesartan Fair-Med
Latvian: Irbesartan HCT FairMed
Bulgarian: 2031 GA
Latvian: 2031 GA Haarlem
Bulgarian: 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Latvian: Medipha Sante Les Fjords - Immeuble Oslo 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Bulgarian: Biofarm Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznaň Poland левоцетиризин хидрохлорид
Latvian: Wałbrzyska 13 60-198 Poznaň Poland levocetirizine hidrohlorīds
Bulgarian: Деслоратадин Desloratadine Smelttablet 2,5 mg Teva, orodispergeerbare tabletten
Latvian: Desloratadine Smelttablet 2,5 mg Teva, orodispergeerbare tabletten
Bulgarian: Hertfordshire SG4 0TW United Kingdom
Latvian: Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Bulgarian: Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska 19 83-200 Starogard Gdański Poland фексофенадин хидрохлорид
Latvian: 83-200 Starogard Gdański Poland fexofenadine hidrohlorīds
Bulgarian: Bulgaria небиволол
Latvian: Bulgaria nebivolol
Bulgarian: Valsartan/hydrochlorthiazi d "Fair-Med" Coated tablets
Latvian: Valsartan/hydrochlorthi azid "Fair-Med" Coated tablets
Bulgarian: Деслоратадин Desloratadine Peseri
Latvian: Desloratadine Peseri
Bulgarian: 3261 LW Oud-Beyerland The Netherlands
Latvian: Benjamin Franklinstraat 5-10 3261 LW Oud-Beyerland The Netherlands
Bulgarian: Metoclopramidemonohydr ochloride Accord 10 mg, Tabletten
Latvian: Metoclopramidemonohy drochloride Accord 10 mg, Tabletten
Bulgarian: Словашка Република
Latvian: Slovākijas Republika
Bulgarian: Edifícios AzevedosEstrada Nacional 117-2, Alfragide
Latvian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Bulgarian: Великобритания Torrent Pharma GmbH Südwestpark 50
Latvian: Lielbritānija Torrent Pharma GmbH Südwestpark 50
Bulgarian: Деслоратадин Desloratadina Alvogen 5 mg comprimate filmate
Latvian: Desloratadina Alvogen 5 mg comprimate filmate
Bulgarian: Romania небиволол
Latvian: Romania nebivolol
Bulgarian: Метформин хидрохлорид metoclopramide hydrochloride 10mg tablets
Latvian: Metoklopramīda hidrohlorīds metoclopramide hydrochloride 10mg tablets
Bulgarian: Цефподоксим Forexo 200 mg comprimate filmate
Latvian: Cefpodoksīm Forexo 200 mg comprimate filmate
Bulgarian: Деслоратадин Alerdin 2,5 mg raspadljive tablete za usta
Latvian: Alerdin 2,5 mg raspadljive tablete za usta
Bulgarian: Деслоратадин Escontral direkt 2,5 mg raspadljiva tableta za usta
Latvian: Escontral direkt 2,5 mg raspadljiva tableta za usta
Bulgarian: 02-954 Warszawa Poland ланзопразол
Latvian: 02-954 Warszawa Poland lansoprazols
Bulgarian: Великобритания Accord Healthcare Limited Sage House, 319 Pinner Road
Latvian: Lielbritānija Accord Healthcare Limited Sage House, 319 Pinner Road
Bulgarian: 02-954 Warszawa Poland венлафаксин
Latvian: 02-954 Warszawa Poland venlafaksīns
Bulgarian: Celon Pharma S.A. Ogrodowa 2A, Kiełpin 05-092 Łomianki, Poland бозентан
Latvian: Ogrodowa 2A, Kiełpin 05-092
Bulgarian: Cyprus левоцетиризин хидрохлорид
Latvian: Cyprus levocetirizine hidrohlorīds
Bulgarian: Деслоратадин Dezloratadin Alvogen 5 mg filmom obalené tablety
Latvian: Dezloratadin Alvogen 5 mg filmom obalené tablety
Bulgarian: Деслоратадин Desloratadin Teva 2.5 mg szájban diszpergálódó tabletta
Latvian: Desloratadin Teva 2.5 mg szájban diszpergálódó tabletta
Bulgarian: 1000 mg таблетка
Latvian: 1000 mg Tablete
Bulgarian: Леводопа/карбид опа/ентакапон
Latvian: Levodopa/karbidopa/ entakapons
Bulgarian: Дексаметазон Dexamethasone 2mg Tablets таблетка
Latvian: Dexamethasone 2mg Tablets
Bulgarian: Триметазидин TRIMETAZIDINE MYLAN 35 mg Modified Release Tablets
Latvian: TRIMETAZIDINE MYLAN 35 mg Modified Release Tablets
Bulgarian: Цефподоксим Forexo 200 mg potahované tablety
Latvian: Cefpodoksīm Forexo 200 mg potahované tablety
Bulgarian: Greece венлафаксин
Latvian: Greece venlafaksīns
Bulgarian: DK-5260 Odense S Denmark фексофенадин хидрохлорид
Latvian: DK-5260 Odense S Denmark fexofenadine hidrohlorīds
Bulgarian: Деслоратадин Desloratadina Teva
Latvian: Desloratadina Teva
Bulgarian: Via Cantu', 11
Latvian: Germed Pharma S.P.A. Via Cantu', 11
Bulgarian: SE-104 35 Stockholm Sweden фексофенадин Nefoxef
Latvian: SE-104 35 Stockholm Sweden fexofenadine
Bulgarian: 2770-071 Edificio D.
Latvian: 2770-071 Edificio D. Pedro I Paco de Arcos
Bulgarian: Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Bulgarian: Nebivolol Torrent 5 mg
Latvian: Nebivolol Torrent 5 mg 5 mg
Bulgarian: Деслоратадин Desloratadin ratiopharm 2,5 mg Schmelztabletten
Latvian: Desloratadin ratiopharm 5 mg Schmelztabletten
Bulgarian: Есциталопрам Escitalopram PharmaS 10 mg filmom obložene tablete
Latvian: Escitalopram PharmaS 10 mg filmom obložene tablete
Bulgarian: Деслоратадин Alvotadin 5 mg filmtabletta
Latvian: Alvotadin 5 mg filmtabletta
Bulgarian: Триметазидин Trimetazidine Mylan 35 mg retard tabletta
Latvian: Trimetazidine Mylan 35 mg retard tabletta
Bulgarian: 90449 Nürnberg Germany венлафаксин
Latvian: 90449 Nürnberg Germany venlafaksīns
Bulgarian: Леветирацетам Levetiracetam beta 1000 mg, Filmtabeltten
Latvian: Levetiracetam beta 1000 mg, Filmtabeltten
Bulgarian: DK-5260 Odense S Denmark метоклопрамид хидрохлорид
Latvian: DK-5260 Odense S Denmark metoklopramīds hidrohlorīds
Bulgarian: Valsartan 320mg Capsules 320 mg капсула
Latvian: Valsartan 320mg Capsules
Bulgarian: The Netherlands Accord Healthcare Limited Sage House, 319 Pinner Road
Latvian: Nīderlande Accord Healthcare Limited Sage House, 319 Pinner Road
Bulgarian: DK-5260 Odense S Denmark фексофенадин Altifex
Latvian: DK-5260 Odense S Denmark fexofenadine
Bulgarian: Valsartan/Hydrochlorothia zide Fair-Med 160 mg/12.5 mg film-coated tablets.
Latvian: Valsartan/Hydrochloroth iazide Fair-Med 160 mg/12.5 mg film-coated tablets.
Bulgarian: 0,5 mg таблетка
Latvian: 0,5 mg Tablete
Bulgarian: TRAMADOL PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Latvian: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Bulgarian: Centrafarm B.V.
Latvian: Nīderlande Centrafarm B.V.
Bulgarian: Деслоратадин Lotera 5 mg potahované tablety
Latvian: Lotera 5 mg potahované tablety
Bulgarian: Хидрокортизон Hydrocortisone 20mg Tablets
Latvian: Hydrocortisone 20mg Tablets
Bulgarian: Piazza Filippo Meda, 4, 3 20121 - Milano Italy венлафаксин
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy venlafaksīns
Bulgarian: Sweden венлафаксин хидрохлорид
Latvian: Sweden venlafaksīns hidrohlorīds
Bulgarian: 200 mg капсула
Latvian: 200 mg Kapsulas
Bulgarian: Алендронова киселина alendronic acid 70mg Once Daily Tablets
Latvian: Alendronskābe alendronic acid 70mg Once Daily Tablets
Bulgarian: Medicplast Polska Sp. z o.o ul. Wólczyńska 232
Latvian: Medicplast Polska Sp. z o.o ul.
Bulgarian: Цефподоксим Trexodo 200 mg filmsko obložene tablete
Latvian: Cefpodoksīm Trexodo 200 mg filmsko obložene tablete
Bulgarian: 97-107 Uxbridge Road London W5 5TL
Latvian: Lielbritānija Aptil Pharma Limited 9th Floor, CP House 97-107 Uxbridge Road London W5 5TL
Bulgarian: Clonazepam 2mg Tablet 2 mg таблетка
Latvian: Clonazepam 2mg Tablet 2 mg
Bulgarian: Piazza Filippo Meda, 4, 3 20121 - Milano Italy ланзопразол
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy lansoprazols
Bulgarian: Деслоратадин LOTERA 5 mg filmom obalené tablety
Latvian: LOTERA 5 mg filmom obalené tablety
Bulgarian: Pioglitazone 30mg Tablets 30 mg таблетка
Latvian: Pioglitazone 30mg Tablets
Bulgarian: Metformin "Actavis PTC" 750 mg таблетка с удължено освобождаване
Latvian: Metformin "Actavis PTC" 750 mg Ilgstošās darbības tablete
Bulgarian: 90449 Nürnberg Germany небиволол
Latvian: 90449 Nürnberg Germany nebivolol
Bulgarian: Десмопресин DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Latvian: DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Bulgarian: 70 mg таблетка
Latvian: 70 mg Tablete
Bulgarian: TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Latvian: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Bulgarian: 150 mg капсула
Latvian: 150 mg Kapsulas
Bulgarian: Valsartan 80mg Capsules 80 mg капсула
Latvian: Valsartan 80mg Capsules
Bulgarian: Триметазидин Apstar 35mg Comprimate cu eliberare prelungită
Latvian: Apstar 35mg Comprimate cu eliberare prelungită
Bulgarian: Clonazepam Sandoz 2 mg, tabletten таблетка
Latvian: Clonazepam Sandoz 2 mg, tabletten
Bulgarian: 32 mg таблетка
Latvian: 32 mg Tablete
Bulgarian: Хидрокортизон Hydrocortisone 10mg Tablets
Latvian: Hydrocortisone 10mg Tablets
Bulgarian: Telmisartan 80mg Tablets 80 mg таблетка
Latvian: Telmisartan 80mg Tablets
Bulgarian: Алендронова киселина alendronic acid 10mg Tablets
Latvian: Alendronskābe alendronic acid 10mg Tablets
Bulgarian: Valsartan/hydrochlorthiazi d "Fair-Med" Coated tablets mg/12,5 mg
Latvian: Valsartan/hydrochlorthi azid "Fair-Med" Coated tablets mg/12,5 mg
Bulgarian: Valsartan 160mg Capsules 160 mg капсула
Latvian: Valsartan 160mg Capsules
Bulgarian: Унгария
Latvian: 32. Hungary
Bulgarian: Amlodipine 5mg Tablets 5 mg таблетка
Latvian: Amlodipine 5mg Tablets 5 mg
Bulgarian: Alvogen IPCo S.àr.l. Rue Heienhaff 5
Latvian: Alvogen IPCo S.àr.l.
Bulgarian: 750 mg таблетка
Latvian: 750 mg Tablete
Bulgarian: Деслоратадин DESLORATADINE GNR 5 mg comprimé pelliculé
Latvian: DESLORATADINE GNR 5 mg comprimé pelliculé
Bulgarian: Spain фексофенадин Fexofenadina Tevagen 180 mg comprimidos recubiertos con pelicula efg
Latvian: Fexofenadina Tevagen 180 mg comprimidos recubiertos con pelicula efg
Bulgarian: 16 mg таблетка
Latvian: 16 mg Tablete
Bulgarian: Spain фексофенадин Fexofenadina Tevagen 120 mg comprimidos recubiertos con pelicula efg
Latvian: Fexofenadina Tevagen 120 mg comprimidos recubiertos con pelicula efg
Bulgarian: Clonazepam TioFarma 2 mg tabletten, tabletten таблетка
Latvian: Clonazepam TioFarma 2 mg tabletten, tabletten
Bulgarian: Portugal небиволол
Latvian: Portugal nebivolol
Bulgarian: Farmaprojects, S.A.U. Santa Eulalia, 240-242 L'Hospitalet de Llobregat 08902 Barcelona Spain венлафаксин
Latvian: L'Hospitalet de Llobregat 08902 Barcelona Spain venlafaksīns
Bulgarian: Цефподоксим FOREXO 200 mg filmom obalené tablety
Latvian: Cefpodoksīm FOREXO 200 mg filmom obalené tablety
Bulgarian: Триметазидин Apstar 35 mg prolonged-release tablets
Latvian: Apstar 35 mg prolonged-release tablets
Bulgarian: Escitalopram 20mg Filmcoated tablets
Latvian: Escitalopram 20mg Film-coated tablets
Bulgarian: Есциталопрам SAVANDRA 20 mg comprimate filmate
Latvian: SAVANDRA 20 mg comprimate filmate
Bulgarian: 50 mg капсула
Latvian: 50 mg Kapsulas
Bulgarian: Valsartan 40mg Capsules 40 mg капсула
Latvian: Valsartan 40mg Capsules
Bulgarian: Pioglitazone 45mg Tablets 45 mg таблетка
Latvian: Pioglitazone 45mg Tablets
Bulgarian: Цефподоксим Rexocef 200 mg filmom obložene tablete
Latvian: Cefpodoksīm Rexocef 200 mg filmom obložene tablete
Bulgarian: Aceon 150mg Prolongedrelease tablets
Latvian: Aceon 150mg Prolonged-release tablets
Bulgarian: Репаглинид
Latvian: Repaglinīds
Bulgarian: Slovakia фексофенадин хидрохлорид
Latvian: Slovakia fexofenadine hidrohlorīds
Bulgarian: Portugal фексофенадин Fexofenadina Generis 180 mg
Latvian: Fexofenadin Generics 180 mg
Bulgarian: Telmisartan 20mg Tablets 20 mg таблетка
Latvian: Telmisartan 20mg Tablets
Bulgarian: Десмопресин DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Latvian: DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Bulgarian: Клобазам
Latvian: Escitaloprāms
Bulgarian: Деслоратадин GESLORA 5 mg
Latvian: Geslora 5 mg
Bulgarian: Деслоратадин Geslora 5 mg
Latvian: GESLORA 5 mg
Bulgarian: Леветирацетам Levetiracetam beta 750 mg, Filmtabletten
Latvian: Levetiracetam beta 750 mg, Filmtabletten
Bulgarian: Telmisartan Dr. Reddy's 80 mg comprimate
Latvian: Reddy's 80 mg comprimate
Bulgarian: 800 mg таблетка
Latvian: 800 mg Tablete
Bulgarian: Pioglitazone 15mg Tablets 15 mg таблетка
Latvian: Pioglitazone 15mg Tablets
Bulgarian: 250 mg таблетка
Latvian: 250 mg Tablete
Bulgarian: Десмопресин DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Latvian: DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Bulgarian: Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA United Kingdom венлафаксин хидрохлорид
Latvian: 115 Narborough Road Leicester, LE3 0PA United Kingdom venlafaksīns hidrohlorīds
Bulgarian: Леветирацетам Levetiracetam beta 250 mg, Filmtabletten
Latvian: Levetiracetam beta 250 mg, Filmtabletten
Bulgarian: Telmisartan 40mg Tablets 40 mg таблетка
Latvian: Telmisartan 40mg Tablets
Bulgarian: Telmisartan Dr. Reddy's 40 mg comprimate
Latvian: Reddy's 40 mg comprimate
Bulgarian: Alvogen IPCo S.ar.l. Rue Heienhaff 5
Latvian: Alvogen IPCo S.ar.l.
Bulgarian: +44 (0)20 3660 8427 Имейл: press@ema.europa.eu
Latvian: Tālr.: +44 (0)20 3660 8427 E-pasts: press@ema.europa.eu
Bulgarian: Препоръката на CHMP е изпратена на Европейската комисия за правно обвързващо решение.
Latvian: CHMP ieteikums tika nosūtīts Eiropas Komisijai likumīgi saistoša lēmuma pieņemšanai.
Bulgarian: Някои от тези лекарства може да останат на пазара в някои държави, ако са изключително важни за пациентите, тъй като алтернативите не могат да отговорят на техните нужди.
Latvian: Dažas no šīm zālēm var palikt tirgū dažās valstīs, ja tās ir kritiski svarīgas pacientiem, jo ar alternatīvām zālēm nevar apmierināt pacientu vajadzības.
Bulgarian: EMA и националните органи ще работят в близко сътрудничество с международните партньори, за да гарантират, че проучванията, използвани като основание за издаване на разрешения за употреба в ЕС, се провеждат в съответствие с най-високите стандарти, както и че участващите фирми спазват изцяло всички аспекти на добрата клинична практика (ДКП).
Latvian: EMA un valsts iestādes cieši sadarbojas ar starptautiskajiem partneriem, lai nodrošinātu, ka pētījumi, uz kuriem pamatojas reģistrācijas apliecības Eiropas Savienībā, tiek veikti pēc augstākajiem standartiem un ka iesaistītie uzņēmumi pilnībā ievēro visus labas klīniskās prakses (GCP) aspektus.
Bulgarian: Системният характер, продължителният период, през който се осъществяват, както и броят на участващите членове на персонала, поставят под съмнение добросъвестността при провеждането на изпитванията на обекта по принцип и надеждността на събраните данни.
Latvian: Pētījumu sistēmiskais raksturs, izstieptais laika periods un iesaistīto darbinieku skaits rada šaubas par izmēģinājumu veikšanas integritāti kopumā un uzticamību iegūtajiem datiem.
Bulgarian: Решението дали едно лекарство е изключително важно за пациентите трябва да се вземе от националните органи на държавите членки на ЕС.
Latvian: Lēmums par zāļu kritisku svarīgumu pacientiem ir jāpieņem ES dalībvalstu valsts iestādēm.
Bulgarian: Проверката разкрива манипулации на данните от електрокардиограмите (ЕКГ) при провеждането на някои проучвания на генерични лекарства, което изглежда продължава от поне пет години.
Latvian: Pārbaudē tika konstatētas manipulācijas ar elektrokardiogrammu (EKG) datiem, veicot dažus ģenērisko zāļu pētījumus, kas, kā izrādījās,bija ilguši vismaz piecus gadus.
Bulgarian: След молба от някои притежатели на разрешения за употреба CHMP преразглежда становището си от януари 2015 г.
Latvian: Pēc dažu reģistrācijas apliecību īpašnieku lūguma CHMP atkārtoti pārskatīja savu 2015. gada janvāra atzinumu.
Bulgarian: Окончателното становище на CHMP е изпратено до Европейската комисия, която издаде окончателно, правно обвързващо решение, валидно във всички държави членки на ЕС, на 16 юли 2015 г.
Latvian: CHMP galīgo atzinumu nosūtīja Eiropas Komisijai, kura 2015. gada 7. jūlijā izsniedza galīgu juridiski saistošu lēmumu, kas piemērojams visām Eiropas Savienības valstīm.
Bulgarian: Комисията издава решение, което важи за всички държави членки, независимо дали те междувременно са взели, или не са взели мерки за временно спиране на лекарствата.
Latvian: Komisija ir sagatavojusi lēmumu, kas attiecas uz visām dalībvalstīm neatkarīgi no tā, vai tās ir/nav veikušas pagaidu pasākumus zāļu reģistrācijas apliecību apturēšanai.
Bulgarian: 1 Bivolet (nebivolol) 5 mg таблетки (притежател на разрешението за употреба:
Latvian: 1 Bivolet (nebivolola) 5 mg tabletes (reģistrācijas apliecības īpašnieks: Neo Balkanika EOOD).
Bulgarian: Това е резултатът от преразглеждане, поискано от притежателите на разрешения за употреба за седем от засегнатите лекарства.
Latvian: Šis ir rezultāts atkārtotai pārskatīšanai, ko septiņām attiecīgajām zālēm pieprasīja reģistrācijas apliecību īpašnieki.
Bulgarian: Лекарствата, които се считат за изключително важни за пациентите, остават налични
Latvian: Zāles, kas ir kritiski svarīgas pacientiem, joprojām būs pieejamas
Bulgarian: Актуализираният списък на лекарствата, за които CHMP препоръчва временно спиране е наличен на уебсайта на EMA.
Latvian: Atjaunināts saraksts ar zālēm, kurām CHMP ieteica reģistrācijas apliecību apturēšanu, ir pieejams EMA vietnē.
Bulgarian: Пациентите трябва да продължат да приемат лекарствата съгласно лекарските предписания и да се свържат със своя лекар или фармацевт, ако имат някакви въпроси.
Latvian: • Pacientiem ir jāturpina lietot zāles, kādas viņiem parakstītas, un jāsazinās ar ārstu vai farmaceitu,
Bulgarian: Прегледът започва на 25 септември 2014 г. по искане на Европейската комисия, по член 31 от Директива 2001/83/ЕО, във връзка с установеното от френската агенция по лекарствата (ANSM) неспазване на добрата клинична практика (ДКП) в обекта на GVK Biosciences в Хайдарабад, Индия.
Latvian: Pārskatīšanu uzsāka 2014. gada 25. septembrī pēc Eiropas Komisijas pieprasījuma saskaņā ar Direktīvas 2001/83/EK 31. pantu saistībā ar Francijas zāļu aģentūras (ANSM) atklājumiem par labas klīniskās prakses (GCP) neatbilstību GVK Biosciences centrā Haidarābādu, Indijā.
Bulgarian: На пациентите и медицинските специалисти се препоръчва следното:
Latvian: Pacientiem un veselības aprūpes speciāliem tiek doti šādi ieteikumi.
Bulgarian: Националните органи ще вземат решение дали някои от лекарствата, препоръчани за временно спиране, са изключително важни в техните държави.
Latvian: Dalībvalstu iestādes lems, vai dažas no zālēm, kurām ieteikta reģistrācijas apliecību apturēšana, ir kritiskas attiecīgajās valstīs.
Bulgarian: Националните органи в ЕС ще обмислят колко важни са отделните лекарства в техните държави и ще вземат окончателни решения дали да ги спрат временно, или да позволят оставането им на пазара, докато бъдат събрани нови данни.
Latvian: • ES valsts iestādes apsvērs, cik kritiskas atsevišķas zāles ir attiecīgajās valstīs, un pieņems galīgos lēmumus par to, vai apturēt zāļu reģistrācijas apliecību, vai arī atļaut to pieejamību, kamēr tiek iegūti jauni dati.
Bulgarian: Някои лекарства, за които се счита, че са изключително важни за пациентите, остават на пазара в някои държави, като се очаква представяне на нови данни.
Latvian: • Dažas zāles, ko uzskata par kritiskām pacientiem, dažās valstīs paliek tirgū līdz jaunu datu iesniegšanai.
Bulgarian: Фирмите имат 12 месеца да представят допълнителни данни за лекарствата, които се считат за изключително важни.
Latvian: Par zālēm, ko uzskata par kritiskām, uzņēmumiem tiek doti 12 mēneši papildu datu iesniegšanai.
Bulgarian: Това изключва едно лекарство, включено в преразглеждането, за което забележките относно проучванията са разрешени.
Latvian: Izņēmums ir vienas zāles, kas bija iekļautas atkārtotajā pārskatīšanā un par kuru izpēti tika izteiktas bažas.
Bulgarian: CHMP отбелязва, че няма доказателства за увреждания или липса на ефективност, свързани с проучванията, провеждани от GVK Biosciences в Хайдарабад.
Latvian: CHMP atzīmēja, ka nav pierādījumu par kaitējumu vai efektivitātes trūkumu saistībā ar GVK Biosciences veiktajiem pētījumiem Haidarābādu.
Bulgarian: Лекарството е премахнато от списъка с лекарства, препоръчани за временно спиране.1
Latvian: Šīs zāles tika izņemtas no to zāļu saraksta, kurām tika ieteikta reģistrācijas apliecību apturēšana.1
Bulgarian: Няма доказателства за увреждания или липса на ефективност при нито едно от лекарствата, свързани с проучванията, провеждани от GVK Biosciences.
Latvian: • Nav pierādījumu par kaitējumu vai efektivitātes trūkumu zālēm, kas saistītas ar GVK Biosciences veiktajiem pētījumiem.
Bulgarian: 2015 г. и на преразглеждането за временно спиране са препоръчани около 700 лекарствени форми и концентрации на лекарствата, проучвани на обекта в Хайдарабад.
Latvian: CHMP 2015. gada janvārī pieņemtā atzinuma un atkārtotas pārskatīšanas rezultātā tika ieteikts apturēt reģistrācijas apliecības aptuveni 700 zāļu formām un zāļu stiprumiem, kas tika pētīti Haidarābādu.