FrancophonIA/ELRC3.0 huggingface dataset:
Romanian: COMPRIMIDOS
Latvian: Tablete
Romanian: 2031 GA Haarlem The Netherlands
Latvian: 2031 GA Haarlem The Netherlands fexofenadine
Romanian: Portugalia Daquimed - Comércio de Produtos Farmacêuticos, S.A.
Latvian: Daquimed - Comércio de Produtos Farmacêuticos, S.A.
Romanian: Calea Floreasca Street No 169A, district 2
Latvian: Sandoz Pharma Services SRL Calea Floreasca Street No 169A, district 2
Romanian: Hidrocortizon
Latvian: Hidrokortizons
Romanian: Farmaceutyczna Spółdzielnia Pracy Galena Krucza 62
Latvian: Farmaceutyczna Spółdzielnia Pracy Galena
Romanian: Bio-Profil Polska Sp.
Latvian: Bio-Profil Polska Sp. z o.o.
Romanian: Unit 6, Fulcrum 1, Solent Way
Latvian: Lielbritānija FDC Pharma Unit 6, Fulcrum 1, Solent Way
Romanian: West Yorkshire WF10 5HX United Kingdom
Latvian: West Yorkshire WF10 5HX United Kingdom fexofenadine
Romanian: 71034 Böblingen Germany
Latvian: 71034 Böblingen Germany venlafaksīns
Romanian: L'Hospitalet de Llobregat 08902 Barcelona
Latvian: L'Hospitalet de Llobregat 08902 Barcelona Spain venlafaksīns
Romanian: România Torrent Pharma SRL Str. Stirbei Voda nr. 36 et.
Latvian: Torrent Pharma SRL Str. Stirbei Voda nr.
Romanian: 20142 Milan Italy
Latvian: 20142 Milan Italy fexofenadine
Romanian: 8502 Lannach Austria
Latvian: 8502 Lannach Austria nebivolol
Romanian: Str. Domniţa Ruxandra nr. 12, parter, sector 2, Bucureşti, România
Latvian: 12, parter, sector 2, Bucureşti, România
Romanian: z o.o. ul. Wałbrzyska 13 60-198 Poznaň Poland
Latvian: Wałbrzyska 13 60-198 Poznaň Poland levocetirizine
Romanian: Portugalia Laboratórios AnovaProdutos Farmacêuticos, Lda.
Latvian: Laboratórios AnovaProdutos Farmacêuticos, Lda.
Romanian: România Labormed Pharma SA Bd. Theodor Pallady nr. 44 B
Latvian: Labormed Pharma SA Bd. Theodor Pallady nr.
Romanian: Rua Alto do Montijo, 131º Dto - Edifício Monsanto Portela de Carnaxide
Latvian: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide 2790-012 Portela de Carnaxide
Romanian: Portugalia Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Latvian: Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Romanian: Levodopa/carbidopa /entacaponă
Latvian: Levodopa/karbidopa/ entakapons
Romanian: PharmaS d.o.o. Radnička cesta 47 Zagreb 10000 Croatia
Latvian: Radnička cesta 47 Zagreb 10000 Croatia
Romanian: Levodopa/Carbidopa/E ntacapone film-coated tablets
Latvian: Levodopa/Carbidopa/En tacapone film-coated tablets
Romanian: Germania Farmaprojects, S.A.U. Santa Eulalia, 240-242
Latvian: Santa Eulalia, 240-242
Romanian: Progefarm S.r.l. Largo Donegani 4/A 28100 - Novara Italy
Latvian: Largo Donegani 4/A 28100 - Novara Italy venlafaksīns
Romanian: Portugalia Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Latvian: Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Romanian: Slovenia Lek farmacevtska družba d.d.
Latvian: Lek farmacevtska družba d.d.
Romanian: Portugalia Teva Pharma - Produtos Farmacêuticos,Lda.
Latvian: Teva Pharma - Produtos Farmacêuticos,Lda.
Romanian: GNR Czech s.r.o. Slavojova 579/9 128 00 Praha 2
Latvian: Slavojova 579/9 128 00 Praha 2
Romanian: z o.o. ul.Ziębicka 40
Latvian: US Pharmacia Sp. z o.o. ul.Ziębicka 40
Romanian: Portugalia Germed Farmacêutica, Lda.
Latvian: Germed Farmacêutica, Lda.
Romanian: Abbott Laboratories Poland Sp.
Latvian: Abbott Laboratories Poland Sp. z o.o. ul.
Romanian: Van-der-Smissen-Strasse 1 D-22767 Hamburg Germany
Latvian: Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D-22767 Hamburg Germany levocetirizine
Romanian: Celon Pharma S.A. Ogrodowa 2A, Kiełpin 05-092 Łomianki, Poland
Latvian: Ogrodowa 2A, Kiełpin 05-092
Romanian: Farmalider, S.A. Aragoneses 15 28108 Madrid Spain
Latvian: Aragoneses 15 28108 Madrid Spain
Romanian: ESOMEPRAZOLE/ GENERICS
Latvian: Esomeprazolmagnijs ESOMEPRAZOLE/ GENERICS
Romanian: Südwestpark 50
Latvian: Generica KG Südwestpark 50
Romanian: Portugalia Sandoz Farmaceutica Lda.
Latvian: Sandoz Farmaceutica Lda.
Romanian: Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º
Latvian: Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal
Romanian: Alembic Pharmaceuticals Europe Limited Palazzo Pietro Stiges, 103, Strait Street
Latvian: Palazzo Pietro Stiges, 103, Strait Street
Romanian: Valsartan/hydrochlort hiazid "Fair-Med"
Latvian: Valsartan/hydrochlorthi azid "Fair-Med"
Romanian: Fenoximetilpenicilin ă
Latvian: Fenoksimetilpenicilīn s
Romanian: RECUBIERTOS CON PELICULA EFG
Latvian: COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Romanian: DK-5260 Odense S Denmark
Latvian: DK-5260 Odense S Denmark fexofenadine
Romanian: Irbesartanas/Hidrochlo rotiazidas Torrent
Latvian: Irbesartanas/Hidrochlor otiazidas Torrent
Romanian: Bosentan monohidrat
Latvian: Czech Republic bosentāna monohidrāts
Romanian: Metoclopramidemonoh ydrochloride Accord 10 mg, Tabletten
Latvian: Metoclopramidemonohy drochloride Accord 10 mg, Tabletten
Romanian: Pantoprazole
Latvian: Pantoprazols
Romanian: Tramadol/paraceta mol
Latvian: Tramadols/ paracetamols
Romanian: Olanda ratiopharm Nederland B.V. Swensweg 5
Latvian: Nīderlande ratiopharm Nederland B.V.
Romanian: Loughrea, Co Galway Ireland
Latvian: Athenry Road, Loughrea, Co Galway Ireland fexofenadine
Romanian: Forum Products Limted Crown House 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom
Latvian: 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom venlafaksīns hidrohlorīds
Romanian: Cefpodoxim Forexo 200 mg comprimate filmate
Latvian: Cefpodoksīm Forexo 200 mg comprimate filmate
Romanian: Germania Unichem Laboratories Ltd. Studio 8B Ard Gaoithe Commercial Centre,
Latvian: Studio 8B Ard Gaoithe Commercial Centre, Business Park
Romanian: Clonazepam Clonazepam 500mcg Tablet
Latvian: Clonazepam 500mcg Tablet
Romanian: YJBPort Limited 74 Briarwood Drive Northwood Hills Middlesex HA6 1PL United Kingdom
Latvian: Lielbritānija YJBPort Limited 74 Briarwood Drive Northwood Hills
Romanian: Brown & Burk UK, Ltd. 5, Marryat Close Hounslow
Latvian: 5, Marryat Close Hounslow
Romanian: Lambda Therapeutic Limited
Latvian: Lambda Therapeutic Limited Sage House
Romanian: 17 Athinon Street Ergates Industrial Area 2643 Ergates P.O. Box 28629
Latvian: Delorbis Pharmaceuticals Ltd 17 Athinon Street Ergates Industrial Area 2643 Ergates
Romanian: Valsartan/hydrochlort hiazid "Fair-Med" Coated tablets
Latvian: Valsartan/hydrochlorthi azid "Fair-Med" Coated tablets
Romanian: Trimetazidină
Latvian: Trimetazidīns
Romanian: Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Romanian: Phenoxymethylpenicilli n 250mg Film-coated Tablets
Latvian: Phenoxymethylpenicillin 250mg Film-coated Tablets
Romanian: Medicplast Polska Sp.
Latvian: Medicplast Polska Sp. z o.o ul.
Romanian: 50-984 Wrocław Poland
Latvian: 50-984 Wrocław Poland fexofenadine hidrohlorīds
Romanian: 3261 LW Oud-Beyerland The Netherlands
Latvian: Benjamin Franklinstraat 5-10 3261 LW Oud-Beyerland The Netherlands
Romanian: Edifícios AzevedosEstrada Nacional 117-2, Alfragide
Latvian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Romanian: Statul Membru SEE
Latvian: Dalībvalsts ES/EEA
Romanian: Levetiracetam LevetiracetamHormosan 1000 mg Filmtabletten
Latvian: LevetiracetamHormosan 1000 mg Filmtabletten
Romanian: Levetiracetam LEVETIRACETAM MYLAN GENERICS
Latvian: LEVETIRACETAM MYLAN GENERICS
Romanian: Dipyridamol
Latvian: Dipiridamols
Romanian: Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
Latvian: Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
Romanian: Germania Torrent Pharma GmbH Südwestpark 50
Latvian: Lielbritānija Torrent Pharma GmbH Südwestpark 50
Romanian: Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene tablete
Latvian: Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene tablete mg/325 mg
Romanian: Ropinirol
Latvian: Ropinirole Accord
Romanian: Nebivolol Torrent 5 mg
Latvian: Nebivolol Torrent 5 mg 5 mg
Romanian: Clonazepam Clonazepam TioFarma 0,5 mg tabletten, tabletten
Latvian: Clonazepam TioFarma 0,5 mg tabletten, tabletten
Romanian: ESOMEPRAZOL MYLAN 40 mg CAPSULAS GASTRORRESISTENTE S EFG
Latvian: ESOMEPRAZOL MYLAN 40 mg CAPSULAS GASTRORRESISTENTES EFG
Romanian: FEXOFENADINE MYLAN 180 Filmcoated Tablet
Latvian: FEXOFENADINE MYLAN 180 Film-coated Tablet
Romanian: ESOMEPRAZOL MYLAN 20 mg CAPSULAS GASTRORRESISTENTE S EFG
Latvian: ESOMEPRAZOL MYLAN 20 mg CAPSULAS GASTRORRESISTENTES EFG
Romanian: Slovakia
Latvian: Slovākija
Romanian: România Terapia SA Str. Fabricii nr. 124 Cluj Napoca
Latvian: 124 Cluj Napoca România venlafaksīns
Romanian: 92707 Colombes Cedex
Latvian: 92707 Colombes Cedex fexofenadine
Romanian: Germania Heumann Pharma GmbH & Co.
Latvian: Heumann Pharma GmbH & Co.
Romanian: FEXOFENADINE MYLAN 120 Filmcoated Tablet
Latvian: FEXOFENADINE MYLAN 120 Film-coated Tablet
Romanian: Clonazepam Clonazepam TioFarma 2 mg tabletten, tabletten
Latvian: Clonazepam TioFarma 2 mg tabletten, tabletten
Romanian: Edifício Monsanto 2790-012 Carnaxide Portugal
Latvian: Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal venlafaksīns
Romanian: Tyvera 100mg Tablets 100 mg
Latvian: Tiamīna hidrohlorīds Tyvera 100mg Tablets 100 mg Tablete
Romanian: Clonazepam Clonazepam Sandoz 0,5 mg, tabletten
Latvian: Clonazepam Sandoz 0,5 mg, tabletten
Romanian: Cefpodoxim Trexodo 200 mg filmsko obložene tablete
Latvian: Cefpodoksīm Trexodo 200 mg filmsko obložene tablete
Romanian: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé
Latvian: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Romanian: Acid alendronic alendronic acid 70mg Once Daily Tablets
Latvian: Alendronskābe alendronic acid 70mg Once Daily Tablets
Romanian: Escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete
Latvian: Escitalopram PharmaS 10 mg filmom obložene tablete
Romanian: Escitalopram Escitalopram Brown 5 mg
Latvian: Escitalopram Brown 5 mg
Romanian: D-80637 München
Latvian: Landshuter Allee 8-10 D-80637 München Germany
Romanian: Telmisartan Dr. Reddy's 40 mg comprimate
Latvian: Reddy's 40 mg comprimate
Romanian: Cefpodoxim Cefpodoxima Alkaloid 200 mg
Latvian: Cefpodoxima Alkaloid 200 mg Tablete
Romanian: Esomylan 40 mg
Latvian: Esomeprazolmagnijs Esomylan 40 mg
Romanian: 05-152 Czosnów k.
Latvian: 05-152 Czosnów k. Warszawy Poland
Romanian: Teva Pharma S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta
Latvian: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta Madrid 28108
Romanian: Diclorhidrat de trimetazidină
Latvian: Trimetazidīna dihidrohlorīds
Romanian: Accord Healthcare, S.L.U. Moll de Barcelona s/n.
Latvian: Moll de Barcelona s/n. World Trade Center.
Romanian: Cefpodoxim Rexocef 200 mg filmom obložene tablete
Latvian: Cefpodoksīm Rexocef 200 mg filmom obložene tablete
Romanian: Germania Accord Healthcare Limited Sage House, 319 Pinner Road
Latvian: Lielbritānija Accord Healthcare Limited Sage House, 319 Pinner Road
Romanian: Farmaceutici Caber S.P.A. Viale Citta' D'Europa, 681 00144 Rome
Latvian: D'Europa, 681 00144 Rome
Romanian: Telmisartan Dr. Reddy's 80 mg comprimate
Latvian: Reddy's 80 mg comprimate
Romanian: Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
Latvian: Levetiracetam beta 750 mg, Filmtabletten
Romanian: Islanda ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Latvian: Islande ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Romanian: ALENDRONATO AHCL 10 mg
Latvian: ALENDRONATO AHCL 10 mg Tablete
Romanian: Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Latvian: Esomeprazolmagnijs Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Romanian: Ebastină
Latvian: Ebastīns
Romanian: TRAMADOL PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé
Latvian: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Romanian: Levetiracetam Letiramyl 1000 mg potahované tablety
Latvian: Letiramyl 1000 mg potahované tablety
Romanian: Clonazepam Clonazepam Sandoz 2 mg, tabletten
Latvian: Clonazepam Sandoz 2 mg, tabletten
Romanian: Desloratadine/Geneph arm 2,5 mg δισκία
Latvian: Desloratadine/Genephar m 2,5 mg δισκία διασπειρόμενα στο στόμα
Romanian: Valsartan/Hydrochloro thiazide Fair-Med 160 mg/12.5 mg filmcoated tablets.
Latvian: Valsartan/Hydrochloroth iazide Fair-Med 160 mg/12.5 mg film-coated tablets.
Romanian: Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Latvian: Esomeprazolmagnijs Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Romanian: Rizatriptan Mylan 5 mg
Latvian: Rizatriptan Mylan 5 mg 5 mg
Romanian: Entacaponă
Latvian: Entakapons
Romanian: Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
Latvian: Levetiracetam beta 250 mg, Filmtabletten
Romanian: Levetiracetam Levetiracetam beta 500 mg, Filmtabletten
Latvian: Levetiracetam beta 500 mg, Filmtabletten
Romanian: Telmisartan/Hydrochlo rothiazide 80mg/25mg Tablets
Latvian: Telmisartan/Hydrochlor othiazide 80mg/25mg Tablets
Romanian: Danemarca Fair-Med Healthcare GmbH Planckstrasse 13
Latvian: Nīderlande Fair-Med Healthcare GmbH Planckstrasse 13
Romanian: Acid alendronic alendronic acid 10mg Tablets
Latvian: Alendronskābe alendronic acid 10mg Tablets
Romanian: Lithuania
Latvian: Lietuva
Romanian: Clorhidrat de venlafaxină
Latvian: Venlafaksīna hidrohlorīds
Romanian: Lanobax 30 mg gastro-resistant capsules, hard
Latvian: Lanobax 30 mg gastroresistant capsules, hard
Romanian: Tyvera 50mg Tablets 50 mg
Latvian: Tiamīna hidrohlorīds Tyvera 50mg Tablets 50 mg Tablete
Romanian: Germania Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7
Latvian: Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7 82031 Grünwald Germany fexofenadine
Romanian: Inaller 5 mg filmtabletta
Latvian: Inaller 5 mg filmtabletta 5 mg
Romanian: În cazul medicamentelor considerate esențiale, companiilor li se acordă 12 luni pentru a prezenta date suplimentare.
Latvian: Par zālēm, ko uzskata par kritiskām, uzņēmumiem tiek doti 12 mēneši papildu datu iesniegšanai.
Romanian: Recomandarea CHMP a fost transmisă Comisiei Europene pentru luarea unei decizii finale obligatorii din punct de vedere juridic.
Latvian: CHMP ieteikums tika nosūtīts Eiropas Komisijai likumīgi saistoša lēmuma pieņemšanai.
Romanian: Este posibil ca o parte dintre aceste medicamente să rămână pe piață în unele țări în cazul în care sunt esențiale pentru pacienți întrucât alternativele nu pot întruni nevoile acestora.
Latvian: Dažas no šīm zālēm var palikt tirgū dažās valstīs, ja tās ir kritiski svarīgas pacientiem, jo ar alternatīvām zālēm nevar apmierināt pacientu vajadzības.
Romanian: • Pacienții trebuie să continue să urmeze tratamentul cu medicamentele respective, conform prescripției, și să contacteze medicul sau farmacistul dacă au întrebări.
Latvian: • Pacientiem ir jāturpina lietot zāles, kādas viņiem parakstītas, un jāsazinās ar ārstu vai farmaceitu,
Romanian: EMA și autoritățile naționale colaborează strâns cu partenerii internaționali pentru a se asigura că studiile pe baza cărora se emit autorizațiile de introducere pe piață în UE sunt efectuate la cele mai înalte standarde și că companiile implicate respectă deplin toate aspectele privind bunele practici clinice(BPC).
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.
Romanian: Medicamentele considerate esențiale pentru pacienți rămân disponibile
Latvian: Zāles, kas ir kritiski svarīgas pacientiem, joprojām būs pieejamas
Romanian: Caracterul sistematic al acestora, perioada extinsă de timp în care au avut loc și numărul de membri ai personalului implicați pun sub semnul întrebării integritatea modului în care au fost desfășurate studiile la acest sediu, în general, și fiabilitatea datelor generate.
Latvian: Pētījumu sistēmiskais raksturs, izstieptais laika periods un iesaistīto darbinieku skaits rada šaubas par izmēģinājumu veikšanas integritāti kopumā un uzticamību iegūtajiem datiem.
Romanian: Decizia dacă un medicament este esențial sau nu pentru pacienți trebuie luată de autoritățile naționale ale statelor membre ale UE.
Latvian: Lēmums par zāļu kritisku svarīgumu pacientiem ir jāpieņem ES dalībvalstu valsts iestādēm.
Romanian: Comisia a emis decizia sa care se aplică în toate statele membre, indiferent dacă au luat sau nu măsuri intermediare de suspendare a medicamentelor.
Latvian: Komisija ir sagatavojusi lēmumu, kas attiecas uz visām dalībvalstīm neatkarīgi no tā, vai tās ir/nav veikušas pagaidu pasākumus zāļu reģistrācijas apliecību apturēšanai.
Romanian: Autoritățile naționale vor decide dacă unele dintre medicamentele recomandate pentru suspendare sunt esențiale în respectivele țări.
Latvian: Dalībvalstu iestādes lems, vai dažas no zālēm, kurām ieteikta reģistrācijas apliecību apturēšana, ir kritiskas attiecīgajās valstīs.
Romanian: • Anumite medicamente considerate esențiale pentru pacienți vor rămâne pe piață în unele țări, în așteptarea furnizării de noi date.
Latvian: • Dažas zāles, ko uzskata par kritiskām pacientiem, dažās valstīs paliek tirgū līdz jaunu datu iesniegšanai.
Romanian: Inspecția a scos la iveală manipulări ale datelor privind rezultatele electrocardiogramelor (ECG) pe durata efectuării unora dintre studiile dedicate medicamentelor generice, situație ce părea să se fi desfășurat pe o perioadă de cel puțin cinci ani.
Latvian: Pārbaudē tika konstatētas manipulācijas ar elektrokardiogrammu (EKG) datiem, veicot dažus ģenērisko zāļu pētījumus, kas, kā izrādījās,bija ilguši vismaz piecus gadus.
Romanian: Acesta este rezultatul unui reexaminări solicitate de titularii autorizației de introducere pe piață pentru șapte dintre medicamentele vizate.
Latvian: Šis ir rezultāts atkārtotai pārskatīšanai, ko septiņām attiecīgajām zālēm pieprasīja reģistrācijas apliecību īpašnieki.
Romanian: • Autoritățile naționale din UE analizează cât de esențiale sunt anumite medicamente în țările respective și vor lua decizia finală de a le suspenda sau de a permite ca acestea să rămână disponibile, în timp ce noi date sunt generate.
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.
Romanian: 1 Bivolet (nebivolol) 5 mg, comprimate (titularul autorizației de introducere pe piață:
Latvian: 1 Bivolet (nebivolola) 5 mg tabletes (reģistrācijas apliecības īpašnieks: Neo Balkanika EOOD).
Romanian: Lista actualizată a medicamentelor în cazul cărora CHMP a recomandat suspendarea este disponibilă pe site-ul EMA.
Latvian: Atjaunināts saraksts ar zālēm, kurām CHMP ieteica reģistrācijas apliecību apturēšanu, ir pieejams EMA vietnē.
Romanian: Avizul final al CHMP a fost transmis Comisiei Europene, care a emis o decizie finală obligatorie din punct de vedere juridic, aplicabilă în toate statele membre ale UE, la 16/07/2015.
Latvian: CHMP galīgo atzinumu nosūtīja Eiropas Komisijai, kura 2015. gada 7. jūlijā izsniedza galīgu juridiski saistošu lēmumu, kas piemērojams visām Eiropas Savienības valstīm.
Romanian: Pacienților și personalului medical li se recomandă următoarele:
Latvian: Pacientiem un veselības aprūpes speciāliem tiek doti šādi ieteikumi.
Romanian: În urma unei solicitări provenite de la câțiva titulari ai autorizației de introducere pe piață, CHMP a reexaminat avizul său emis în ianuarie 2015.
Latvian: Pēc dažu reģistrācijas apliecību īpašnieku lūguma CHMP atkārtoti pārskatīja savu 2015. gada janvāra atzinumu.
Romanian: Evaluarea a fost inițiată la 25 septembrie 2014, la solicitarea Comisiei Europene, în temeiul articolului 31 din Directiva 2001/ 83/ CE, pe baza concluziilor agenției franceze pentru medicamente (ANSM) legate de nerespectarea bunelor practici clinice (BPC) la sediul GVK Biosciences din Hyderabad, India.
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.
Romanian: În timpul reexaminării, CHMP a concluzionat că motivele de îngrijorare legate de fiabilitatea studiilor clinice rămân valabile și ca atare și-a menținut recomandarea din ianuarie 2015 de a suspenda medicamentele pentru care nu erau disponibile date justificative provenite din alte studii.
Latvian: Atkārtotās pārskatīšanas laikā CHMP secināja, ka šaubas par klīnisko pētījumu uzticamību joprojām pastāv, un tāpēc tika saglabāts tās 2015. gada janvāra ieteikums apturēt to zāļu reģistrācijas apliecības, kurām nebija pieejami atbalstoši dati no citiem pētījumiem.
Romanian: Evaluarea a fost realizată de Comitetul pentru medicamente de uz uman (CHMP), responsabil pentru problemele care privesc medicamentele de uz uman, care, în ianuarie 2015, a adoptat un aviz privind autorizația de introducere pe piață pentru aceste medicamente.
Latvian: Pārskatīšanu veica Cilvēkiem paredzēto zāļu komiteja (CHMP), kas ir atbildīga par jautājumiem saistībā ar cilvēkiem paredzētajām zālēm un kas 2015. gada janvārī pieņēma atzinumu par šo zāļu reģistrācijas apliecību.
Romanian: • Nu există dovezi ale efectelor dăunătoare sau ale lipsei eficacității în cazul niciunuia dintre medicamentele care au legătură cu studiile efectuate de GVK Biosciences.
Latvian: • Nav pierādījumu par kaitējumu vai efektivitātes trūkumu zālēm, kas saistītas ar GVK Biosciences veiktajiem pētījumiem.
Romanian: Respectivul medicament a fost exclus de pe lista medicamentelor recomandate pentru suspendare.1
Latvian: Šīs zāles tika izņemtas no to zāļu saraksta, kurām tika ieteikta reģistrācijas apliecību apturēšana.1
Romanian: suficiente date justificative provenite din alte surse; în consecință, respectivele medicamente vor rămâne pe piață în UE.
Latvian: Aptuveni 300 citām zāļu formām un stiprumiem tika sniegti pietiekami atbalstoši dati no citiem avotiem, tāpēc šīs zāles paliek ES tirgū.
Romanian: Ca urmare a avizului emis de CHMP în ianuarie 2015 și a reexaminării, au fost recomandate pentru suspendare aproximativ 700 forme farmaceutice și concentrații de medicamente studiate la sediul din Hyderabad.
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.
Romanian: CHMP a remarcat că nu există dovezi ale efectelor dăunătoare sau ale lipsei eficacității care să derive din studiile efectuate de GVK Biosciences la Hyderabad.
Latvian: CHMP atzīmēja, ka nav pierādījumu par kaitējumu vai efektivitātes trūkumu saistībā ar GVK Biosciences veiktajiem pētījumiem Haidarābādu.
Romanian: Recomandarea a rămas valabilă cu excepția unui medicament inclus în procesul de reexaminare, în cazul căruia problemele legate de studii au fost soluționate.
Latvian: Izņēmums ir vienas zāles, kas bija iekļautas atkārtotajā pārskatīšanā un par kuru izpēti tika izteiktas bažas.
Romanian: La 21 mai 2015, Agenția Europeană pentru Medicamente (EMA) a confirmat recomandarea sa de suspendare a anumitor medicamente pentru care autorizația pe teritoriul Uniunii Europene (UE) a avut la bază în principal studii clinice desfășurate la sediul GVK Biosciences din Hyderabad, India.
Latvian: Eiropas Zāļu aģentūra (EMA) 2015. gada 21. maijā apstiprināja tās ieteikumu apturēt vairāku to zāļu reģistrācijas apliecības, kurām reģistrācija Eiropas Savienībā (ES) galvenokārt tika balstīta uz klīniskajiem pētījumiem, kas veikti GVK Biosciences centrā Haidarābādu, Indijā.
Romanian: Evaluarea a inclus medicamente autorizate pe plan național, ale căror cereri de autorizație de introducere pe piață includeau date clinice provenite din studii desfășurate de GVK Biosciences la sediul său din Hyderabad.
Latvian: Pārskatā bija iekļautas nacionāli apstiprinātās zāles, kuru reģistrācijas apliecības iesniegumos bija iekļauti klīniskie dati no pētījumiem, ko veica GVK Biosciences, kas atrodas Haidarābādu.
Romanian: Tel.
Latvian: ja rodas jautājumi.