FrancophonIA/ELRC3.0 huggingface dataset:
Danish: 3771 ME Barneveld The Netherlands
Latvian: 3771 ME Barneveld The Netherlands fexofenadine
Danish: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal
Latvian: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal nebivolol
Danish: Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany
Latvian: Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany venlafaksīns
Danish: Storbritannien Wockhardt UK Limited Ash Road North
Latvian: Lielbritānija Wockhardt UK Limited Ash Road North
Danish: Esomeprazolmagnesium ESOMEPRAZOLE/ GENERICS
Latvian: Esomeprazolmagnijs ESOMEPRAZOLE/ GENERICS
Danish: Wałbrzyska 13 60-198 Poznaň Poland
Latvian: Wałbrzyska 13 60-198 Poznaň Poland levocetirizine
Danish: Rumænien Dr. Reddy's Laboratories Romania SRL
Latvian: Reddy's Laboratories Romania SRL
Danish: Cherni vrah 14, bl.3
Latvian: Cherni vrah 14, bl.3 Sofia 1421
Danish: Grækenland Genepharm S.A. 18 Km Marathon Avenue, 15351 Pallini
Latvian: 18 Km Marathon Avenue, 15351 Pallini Greece
Danish: Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Latvian: Luksemburga Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Danish: Holland ratiopharm Nederland B.V.
Latvian: Nīderlande ratiopharm Nederland B.V.
Danish: 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom
Latvian: 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom venlafaksīns hidrohlorīds
Danish: H-4042 Debrecen Pallagi út 13.
Latvian: Teva Gyógyszergyár Zrt. H-4042 Debrecen Pallagi út 13.
Danish: Tramadol/paracetamol
Latvian: Tramadols/ paracetamols
Danish: UAB Norameda Meistru 8a Vilnius LT-02189 Lithuania
Latvian: UAB Norameda Meistru 8a Vilnius LT-02189 Lithuania bosentāna
Danish: Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom irbesartan
Latvian: Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Danish: Via dei Sabini, 28 63100 - Ascoli Piceno Italy
Latvian: FB Health S.p.A. Via dei Sabini, 28 63100 - Ascoli Piceno Italy venlafaksīns
Danish: Sussex BN22 9AG United Kingdom
Latvian: Sussex BN22 9AG United Kingdom fexofenadine
Danish: 2031 GA Haarlem The Netherlands
Latvian: 2031 GA Haarlem The Netherlands fexofenadine
Danish: Bilag IA: Lægemidler, for hvilke markedsføringstilladelserne anbefales opretholdt Medlemsland (i EØS)
Latvian: Pielikums: Zāles, kuru reģistrācijas apliecības tiek ieteikts saglabāt Dalībvalsts
Danish: Ranbaxy Italia S.P.A.
Latvian: Ranbaxy Italia S.P.
Danish: Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D-22767 Hamburg Germany
Latvian: Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D-22767 Hamburg Germany levocetirizine
Danish: Calea Floreasca Street No 169A, district 2
Latvian: Sandoz Pharma Services SRL Calea Floreasca Street No 169A, district 2
Danish: West Yorkshire WF10 5HX United Kingdom
Latvian: West Yorkshire WF10 5HX United Kingdom fexofenadine
Danish: Esomeprazolmagnesium Esopragen
Latvian: Esomeprazolmagnijs Esopragen
Danish: 71034 Böblingen Germany
Latvian: 71034 Böblingen Germany venlafaksīns
Danish: 20142 Milan Italy
Latvian: 20142 Milan Italy fexofenadine
Danish: 8502 Lannach Austria
Latvian: 8502 Lannach Austria nebivolol
Danish: Storbritannien Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Latvian: Lielbritānija Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Danish: Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Latvian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Danish: L'Hospitalet de Llobregat 08902 Barcelona
Latvian: L'Hospitalet de Llobregat 08902 Barcelona Spain venlafaksīns
Danish: Str. Domniţa Ruxandra nr.
Latvian: Teva Pharmaceuticals S.R.L. Str. Domniţa Ruxandra nr.
Danish: Storbritannien Morningside Healthcare Limited
Latvian: Lielbritānija Morningside Healthcare Limited
Danish: Tablets
Latvian: Tablete
Danish: Grækenland Sieger Pharma A.E. Marathonos Avenue 106
Latvian: Sieger Pharma A.E. Marathonos Avenue 106 Pikermi 19009
Danish: Slovenien Lek farmacevtska družba d.d.
Latvian: Lek farmacevtska družba d.d.
Danish: Esomeprazolmagnesium Esomylan 40 mg
Latvian: Esomeprazolmagnijs Esomylan 40 mg
Danish: Farmalider, S.A. Aragoneses 15 28108 Madrid Spain
Latvian: Aragoneses 15 28108 Madrid Spain
Danish: Irbesartanas/Hidrochlorot iazidas Torrent
Latvian: Irbesartanas/Hidrochlor otiazidas Torrent
Danish: Abbott Laboratories Poland Sp. z o.o.
Latvian: Abbott Laboratories Poland Sp. z o.o. ul.
Danish: Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Danish: Unichem Laboratories Ltd. Studio 8B Ard Gaoithe Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary
Latvian: Studio 8B Ard Gaoithe Commercial Centre, Business Park
Danish: Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal
Latvian: Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal venlafaksīns
Danish: Alembic Pharmaceuticals Europe Limited Palazzo Pietro Stiges, 103, Strait Street
Latvian: Palazzo Pietro Stiges, 103, Strait Street
Danish: Cipla Chanelle Generics Limited Athenry Road,
Latvian: Cipla Chanelle Generics Limited
Danish: Tactica Pharmaceuticals sp. z o.o.
Latvian: Tactica Pharmaceuticals sp. z o.o. ul.
Danish: DK-5260 Odense S Denmark
Latvian: DK-5260 Odense S Denmark fexofenadine
Danish: Cefpodoxima Alkaloid 200 mg Tablet
Latvian: Cefpodoxima Alkaloid 200 mg Tablete
Danish: Celon Pharma S.A. Ogrodowa 2A, Kiełpin 05-092 Łomianki, Poland
Latvian: Ogrodowa 2A, Kiełpin 05-092
Danish: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal
Latvian: João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal
Danish: S-Lab Sp. z o.o.
Latvian: S-Lab Sp. z o.o. ul.
Danish: Metforminhydrochlorid Bolamyn/Metabet SR 1000mg Prolonged
Latvian: Bolamyn/Metabet SR 1000mg Prolonged Release Tablets
Danish: Hydrocortison
Latvian: Hidrokortizons
Danish: 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
Danish: Chanelle Medical Dublin road Loughrea, Co. Galway Ireland
Latvian: Chanelle Medical Dublin road Loughrea, Co.
Danish: Brown & Burk UK, Ltd. 5, Marryat Close Hounslow
Latvian: 5, Marryat Close Hounslow
Danish: Tacpan 1 mg Hartkapseln 1 mg
Latvian: Tacpan 1 mg Hartkapseln
Danish: Valsartan/hydrochlorthiaz id "Fair-Med"
Latvian: Valsartan/hydrochlorthi azid "Fair-Med"
Danish: Metoclopramide Orifarm 10 mg Tablet
Latvian: Metoclopramide Orifarm 10 mg Tablete
Danish: Via Rossellini Ippolito, 12 20124 Milan
Latvian: Pensa Pharma S.P.A. Via Rossellini Ippolito, 12 20124 Milan
Danish: Loughrea, Co Galway Ireland
Latvian: Athenry Road, Loughrea, Co Galway Ireland fexofenadine
Danish: Esomeprazolmagnesium Esomeprazole 20mg Gastro-resistant
Latvian: Esomeprazolmagnijs Esomeprazole 20mg Gastro-resistant
Danish: Ewopharma International s.r.o., Hlavna 13
Latvian: Ewopharma International s.r.o.,
Danish: 3261 LW Oud-Beyerland The Netherlands
Latvian: Benjamin Franklinstraat 5-10 3261 LW Oud-Beyerland The Netherlands
Danish: 1000 mg Tablet
Latvian: 1000 mg Tablete
Danish: Esomeprazolmagnesium Esomeprazole 40mg Gastro-resistant
Latvian: Esomeprazolmagnijs Esomeprazole 40mg Gastro-resistant
Danish: Levetiracetam LEVETIRACETAM MYLAN GENERICS
Latvian: LEVETIRACETAM MYLAN GENERICS
Danish: 50-984 Wrocław Poland
Latvian: 50-984 Wrocław Poland fexofenadine hidrohlorīds
Danish: Forexo 200 mg comprimate filmate
Latvian: Cefpodoksīm Forexo 200 mg comprimate filmate
Danish: Bulgarien Neo Balkanika EOOD 35 Zemliane Str.
Latvian: Neo Balkanika EOOD 35 Zemliane Str. Sofia 1618
Danish: Valsartan/hydrochlorthiaz id "Fair-Med" Coated tablets
Latvian: Valsartan/hydrochlorthi azid "Fair-Med" Coated tablets
Danish: Metoclopramidemonohydr ochloride Accord 10 mg, Tabletten
Latvian: Metoclopramidemonohy drochloride Accord 10 mg, Tabletten
Danish: Forexo 200 mg potahované tablety
Latvian: Cefpodoksīm Forexo 200 mg potahované tablety
Danish: Via Cantu', 11
Latvian: Germed Pharma S.P.A. Via Cantu', 11
Danish: Metforminhydrochlorid Gluforlyn XR 500 mg retard tabletta
Latvian: Gluforlyn XR 500 mg retard tabletta
Danish: Storbritannien Fair-Med Healthcare GmbH Planckstrasse 13
Latvian: Lielbritānija Fair-Med Healthcare GmbH Planckstrasse 13
Danish: 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
Danish: Storbritannien Bluefish Pharmaceuticals AB Torsgatan 11
Latvian: Lielbritānija Bluefish Pharmaceuticals AB Torsgatan 11
Danish: 320 mg Kapsel
Latvian: 320 mg Kapsulas
Danish: Dipyridamol
Latvian: Dipiridamols
Danish: Levodopa/carbidopa/ent acapon
Latvian: Levodopa/karbidopa/ entakapons
Danish: Levetiracetam Levetiracetam beta 1000 mg, Filmtabeltten
Latvian: Levetiracetam beta 1000 mg, Filmtabeltten
Danish: Phenoxymethylpenicillin Phenoxymethylpenicillin 250mg Film-coated
Latvian: Phenoxymethylpenicillin 250mg Film-coated Tablets
Danish: ALENDRONATO AHCL 10 mg Tablet
Latvian: ALENDRONATO AHCL 10 mg Tablete
Danish: Storbritannien Accord Healthcare Limited Sage House, 319 Pinner Road
Latvian: Lielbritānija Accord Healthcare Limited Sage House, 319 Pinner Road
Danish: Alendroninsyre alendronic acid 70mg Once Daily Tablets
Latvian: Alendronskābe alendronic acid 70mg Once Daily Tablets
Danish: Pantoprazol
Latvian: Pantoprazols
Danish: 2,5 mg Tablet
Latvian: 2,5 mg Tablete
Danish: Calea Torontalului km 6PITT
Latvian: STADA Hemofarm S.R.L. Calea Torontalului km 6PITT
Danish: VALSARTAN ORION 320 mg Filmovertrukket tablet
Latvian: VALSARTAN ORION 320 mg Apvalkotā tablete
Danish: Holland
Latvian: The Netherlands
Danish: 0,5 mg Tablet
Latvian: 0,5 mg Tablete
Danish: VALSARTAN/HIDROCLOR OTIAZIDA CODRAMOL 320/25 MG
Latvian: VALSARTAN/HIDROCLO ROTIAZIDA CODRAMOL 320/25 MG
Danish: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé
Latvian: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Danish: Germany irbesartan
Latvian: Germany levetiracetāms
Danish: Rumænien Torrent Pharma SRL Str. Stirbei Voda nr. 36 et. 2, biroul A, sector 1
Latvian: Torrent Pharma SRL Str. Stirbei Voda nr.
Danish: VALSARTAN/HIDROCLOR OTIAZIDA CODRAMOL 160/25 MG
Latvian: VALSARTAN/HIDROCLO ROTIAZIDA CODRAMOL 160/25 MG
Danish: Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska 19 83-200 Starogard Gdański Poland
Latvian: 83-200 Starogard Gdański Poland fexofenadine hidrohlorīds
Danish: 0,5 mg Kapsel, hård Oral anvendelse
Latvian: 0,5 mg Cietās kapsulas Iekšķīgai lietošanai
Danish: Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
Latvian: Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
Danish: Metforminhydrochlorid Metformin Actavis Retard 750 mg
Latvian: Metformin Actavis Retard 750 mg
Danish: Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Latvian: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid)
Danish: Tacpan 5 mg Hartkapseln 5 mg
Latvian: Tacpan 5 mg Hartkapseln
Danish: Bendroflumethiazid Bendroflumetiazid Alternova
Latvian: DK-4230 Skælskør Denmark bendroflumethiazide Bendroflumetiazid Alternova
Danish: Trexodo 200 mg filmsko obložene tablete
Latvian: Cefpodoksīm Trexodo 200 mg filmsko obložene tablete
Danish: Ropinirolhydrochlorid Ropinirole Lambda
Latvian: Ropinirole Lambda
Danish: Telmisartan Dr. Reddy's 40 mg comprimate
Latvian: Reddy's 40 mg comprimate
Danish: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé
Latvian: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Danish: Thiaminhydrochlorid Tyvera 100mg Tablets 100 mg Tablet
Latvian: Tiamīna hidrohlorīds Tyvera 100mg Tablets 100 mg Tablete
Danish: Kapsel, hård Oral anvendelse
Latvian: Cietās kapsulas Iekšķīgai lietošanai
Danish: ALENDRONATO AHCL 70 mg Tablet
Latvian: ALENDRONATO AHCL 70 mg Tablete
Danish: Valsartan/Hydrochlorothi azide Fair-Med 160 mg/12.5 mg film-coated tablets.
Latvian: Valsartan/Hydrochloroth iazide Fair-Med 160 mg/12.5 mg film-coated tablets.
Danish: FOREXO 200 mg filmom obalené tablety
Latvian: Cefpodoksīm FOREXO 200 mg filmom obalené tablety
Danish: Apo-trimetazidin 35 mg 35 mg Depottablet
Latvian: Apo-trimetazidin 35 mg 35 mg Ilgstošās darbības tablete
Danish: Spanien RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura, 11
Latvian: RATIOPHARM ESPAÑA, S.A.
Danish: 750 mg Tablet
Latvian: 750 mg Tablete
Danish: Telmisartan HCT Dr. Reddy's 80 mg/25 mg comprimate
Latvian: Reddy's 80 mg/25 mg comprimate
Danish: 200 mg Kapsel
Latvian: 200 mg Kapsulas
Danish: Telmisartan Dr. Reddy's 80 mg comprimate
Latvian: Reddy's 80 mg comprimate
Danish: 250 mg Tablet
Latvian: 250 mg Tablete
Danish: 12, parter, sector 2,
Latvian: 12, parter, sector 2, Bucureşti, România
Danish: Donepezil
Latvian: Donezil
Danish: Donepezilhydrochlorid DONEPEZIL MYLAN GENERICS ITALIA
Latvian: DONEPEZIL MYLAN GENERICS ITALIA
Danish: Esomeprazolmagnesium Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula
Latvian: Esomeprazolmagnijs Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Danish: Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
Latvian: Levetiracetam beta 750 mg, Filmtabletten
Danish: Storbritannien Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Latvian: Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Danish: Trimetazidin
Latvian: Trimetazidīns
Danish: Bulgarien Accord Healthcare Limited Sage House, 319 Pinner Road
Latvian: Nīderlande Accord Healthcare Limited Sage House, 319 Pinner Road
Danish: Thiaminhydrochlorid Tyvera 50mg Tablets 50 mg Tablet
Latvian: Tiamīna hidrohlorīds Tyvera 50mg Tablets 50 mg Tablete
Danish: 70 mg tablet
Latvian: 70 mg Tablete
Danish: Levetiracetam Letiramyl 1000 mg potahované tablety
Latvian: Letiramyl 1000 mg potahované tablety
Danish: 50 mg Kapsel
Latvian: 50 mg Kapsulas
Danish: Esomeprazolmagnesium Neximyl 40 mg magensaftresistente Hartkapseln
Latvian: Esomeprazolmagnijs Neximyl 40 mg magensaftresistente Hartkapseln
Danish: Metforminhydrochlorid Metformin Actavis Retard 500 mg
Latvian: Metformin Actavis Retard 500 mg
Danish: Labesfal, Genéricos, S.A. Av. Dr. Afonso Costa, nº
Latvian: Afonso Costa, nº
Danish: 500 mg Tablet
Latvian: 500 mg Tablete
Danish: Metformin "Actavis PTC" 500 mg Depottablet
Latvian: Metformin "Actavis PTC" 500 mg Ilgstošās darbības tablete
Danish: Repaglinid
Latvian: Repaglinīds
Danish: Metformin SR Actavis 750 mg Filmovertrukket tablet
Latvian: Metformin SR Actavis 750 mg Apvalkotā tablete
Danish: Esomeprazolmagnesium Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula
Latvian: Esomeprazolmagnijs Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Danish: 160 mg Kapsel
Latvian: 160 mg Kapsulas
Danish: Esomeprazolmagnesium Neximyl 20 mg magensaftresistente Hartkapseln
Latvian: Esomeprazolmagnijs Neximyl 20 mg magensaftresistente Hartkapseln
Danish: 150 mg Kapsel
Latvian: 150 mg Kapsulas
Danish: 200 mg Tablet
Latvian: 200 mg Tablete
Danish: Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
Latvian: Levetiracetam beta 250 mg, Filmtabletten
Danish: VALSARTAN ORION 160 mg Filmovertrukket tablet
Latvian: VALSARTAN ORION 160 mg Apvalkotā tablete
Danish: Rexocef 200 mg filmom obložene tablete
Latvian: Cefpodoksīm Rexocef 200 mg filmom obložene tablete
Danish: Levetiracetam LEVETIRACETAM MYLAN PHARMA 1000mg, comprimé pelliculé
Latvian: LEVETIRACETAM MYLAN PHARMA 1000mg, comprimé pelliculé
Danish: 30 mg Tablet
Latvian: 30 mg Tablete
Danish: 32 mg tablet
Latvian: 32 mg Tablete
Danish: 20 mg Tablet
Latvian: 20 mg Tablete
Danish: Bosentanmonohydrat Bosentan Sandoz 62,5 mg
Latvian: Bosentan Sandoz 62,5 mg
Danish: Escitalopram 20mg Filmcoated tablets
Latvian: Escitalopram 20mg Film-coated tablets
Danish: 800 mg Tablet
Latvian: 800 mg Tablete
Danish: Levetiracetam Levetiracetam-Hormosan 750 mg Filmtabletten
Latvian: LevetiracetamHormosan 750 mg Filmtabletten
Danish: România
Latvian: Rumānija
Danish: 16 mg Tablet
Latvian: 16 mg Tablete
Danish: For ca. 300 andre lægemiddelformer og -styrker var der tilvejebragt tilstrækkelige underbyggende data fra andre kilder, hvorfor disse lægemidler vil forblive på markedet i EU.
Latvian: Aptuveni 300 citām zāļu formām un stiprumiem tika sniegti pietiekami atbalstoši dati no citiem avotiem, tāpēc šīs zāles paliek ES tirgū.
Danish: CHMP's anbefaling blev fremsendt til Europa-Kommissionen for en juridisk bindende beslutning.
Latvian: CHMP ieteikums tika nosūtīts Eiropas Komisijai likumīgi saistoša lēmuma pieņemšanai.
Danish: For lægemidler, der betragtes som værende af kritisk betydning, gives virksomheder 12 måneder til at fremsende yderligere data.
Latvian: Par zālēm, ko uzskata par kritiskām, uzņēmumiem tiek doti 12 mēneši papildu datu iesniegšanai.
Danish: 1 Bivolet (nebivolol), tabletter a 5 mg (indehaver af markedsføringstilladelsen: Neo Balkanika EOOD).
Latvian: 1 Bivolet (nebivolola) 5 mg tabletes (reģistrācijas apliecības īpašnieks: Neo Balkanika EOOD).
Danish: Nogle af disse lægemidler kan forblive på markedet i nogle lande, hvis de er af kritisk betydning for patienter, fordi alternative lægemiddelformer ikke kan opfylde patienters behov.
Latvian: Dažas no šīm zālēm var palikt tirgū dažās valstīs, ja tās ir kritiski svarīgas pacientiem, jo ar alternatīvām zālēm nevar apmierināt pacientu vajadzības.
Danish: Deres systematiske natur, den lange periode, hvor de fandt sted, og antallet af involverede medarbejdere gjorde, at der opstod tvivl om integriteten af forsøgenes gennemførelse generelt og om de frembragte datas pålidelighed.
Latvian: Pētījumu sistēmiskais raksturs, izstieptais laika periods un iesaistīto darbinieku skaits rada šaubas par izmēģinājumu veikšanas integritāti kopumā un uzticamību iegūtajiem datiem.
Danish: EMA og de nationale myndigheder arbejder tæt sammen med internationale partnere for at sikre, at undersøgelser, der underbygger markedsføringstilladelser i EU, udføres efter de højeste standarder, og at de involverede firmaer fuldt ud opfylder alle aspekter af god klinisk praksis (GCP).
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.
Danish: Kommissionen har truffet sin afgørelse, som gælder for alle medlemsstater, uanset om de har taget midlertidige foranstaltninger til at suspendere lægemidler eller ej.
Latvian: Komisija ir sagatavojusi lēmumu, kas attiecas uz visām dalībvalstīm neatkarīgi no tā, vai tās ir/nav veikušas pagaidu pasākumus zāļu reģistrācijas apliecību apturēšanai.
Danish: Inspektionen afslørede datamanipulationer af elektrokardiogrammer (EKG'er) under udførelsen af nogle undersøgelser af generiske lægemidler, som tilsyneladende havde fundet sted over en periode på mindst fem år.
Latvian: Pārbaudē tika konstatētas manipulācijas ar elektrokardiogrammu (EKG) datiem, veicot dažus ģenērisko zāļu pētījumus, kas, kā izrādījās,bija ilguši vismaz piecus gadus.
Danish: Afgørelsen af, om et lægemiddel er af kritisk betydning for patienter, ligger hos EU-medlemsstaternes nationale myndigheder.
Latvian: Lēmums par zāļu kritisku svarīgumu pacientiem ir jāpieņem ES dalībvalstu valsts iestādēm.
Danish: • Patienter bør fortsætte med at tage deres lægemidler som ordineret og kontakte deres læge eller apoteket, hvis de har spørgsmål.
Latvian: • Pacientiem ir jāturpina lietot zāles, kādas viņiem parakstītas, un jāsazinās ar ārstu vai farmaceitu,
Danish: CHMP's endelige udtalelse blev fremsendt til Europa-Kommissionen, der vedtog en endelig, juridisk bindende afgørelse med gyldighed i alle EU-medlemsstaterne den 16. juli 2015.
Latvian: CHMP galīgo atzinumu nosūtīja Eiropas Komisijai, kura 2015. gada 7. jūlijā izsniedza galīgu juridiski saistošu lēmumu, kas piemērojams visām Eiropas Savienības valstīm.
Danish: Den opdaterede liste over lægemidler, for hvilke CHMP anbefalede suspendering, er tilgængelig på EMA's websted.
Latvian: Atjaunināts saraksts ar zālēm, kurām CHMP ieteica reģistrācijas apliecību apturēšanu, ir pieejams EMA vietnē.
Danish: Efter anmodning fra visse indehavere af markedsføringstilladelser tog CHMP sin udtalelse fra januar 2015 op til fornyet overvejelse.
Latvian: Pēc dažu reģistrācijas apliecību īpašnieku lūguma CHMP atkārtoti pārskatīja savu 2015. gada janvāra atzinumu.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som i januar 2015 vedtog en udtalelse om markedsføringstilladelsen af disse lægemidler.
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.
Danish: De nationale myndigheder vil afgøre, om nogle af de lægemidler, der er anbefalet til suspendering, er af kritisk betydning i deres lande.
Latvian: Dalībvalstu iestādes lems, vai dažas no zālēm, kurām ieteikta reģistrācijas apliecību apturēšana, ir kritiskas attiecīgajās valstīs.
Danish: • De nationale myndigheder i EU vil overveje, hvor kritisk vigtige individuelle lægemidler er i deres lande, og træffe de endelige afgørelser om suspendering eller tilladelse til at forblive på markedet, mens nye data fremskaffes.
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.
Danish: • Nogle lægemidler, der betragtes som værende af kritisk betydning for patienter, vil forblive på markedet i nogle lande med forbehold for fremlæggelsen af nye data.
Latvian: • Dažas zāles, ko uzskata par kritiskām pacientiem, dažās valstīs paliek tirgū līdz jaunu datu iesniegšanai.
Danish: Lægemidler, der betragtes som værende af kritisk betydning for patienter, kan stadig fås
Latvian: Zāles, kas ir kritiski svarīgas pacientiem, joprojām būs pieejamas
Danish: CHMP konkluderede ved den fornyede overvejelse, at der fortsat herskede usikkerhed omkring de kliniske undersøgelsers pålidelighed, og opretholdt derfor sin anbefaling fra januar 2015 om suspendering af lægemidler, for hvilke ingen underbyggende data fra andre undersøgelser var tilgængelige.
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.
Danish: Dette er resultatet af en fornyet overvejelse efter anmodning fra indehavere af markedsføringstilladelserne for syv af de berørte lægemidler.
Latvian: Šis ir rezultāts atkārtotai pārskatīšanai, ko septiņām attiecīgajām zālēm pieprasīja reģistrācijas apliecību īpašnieki.
Danish: Patienter og sundhedspersonale gøres opmærksomme på følgende:
Latvian: Pacientiem un veselības aprūpes speciāliem tiek doti šādi ieteikumi.
Danish: Gennemgangen blev påbegyndt den 25. september 2014 efter anmodning fra Europa-Kommissionen i henhold til artikel 31 i direktiv 2001/83/EF i forbindelse med det franske lægemiddelagenturs påvisning af manglende overensstemmelse med god klinisk praksis (GCP) på GVK Biosciences' anlæg i Hyderabad, Indien.
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.
Danish: Dette med undtagelse af ét lægemiddel omfattet af den fornyede overvejelse, for hvilket bekymringer omkring undersøgelserne blev imødegået.
Latvian: Izņēmums ir vienas zāles, kas bija iekļautas atkārtotajā pārskatīšanā un par kuru izpēti tika izteiktas bažas.
Danish: Dette lægemiddel blev fjernet fra den liste over lægemidler, som var anbefalet til suspendering.1
Latvian: Šīs zāles tika izņemtas no to zāļu saraksta, kurām tika ieteikta reģistrācijas apliecību apturēšana.1