FrancophonIA/ELRC3.0 huggingface dataset:
Italian: Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom irbesartan
Swedish: Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Italian: Regno Unito Brown & Burk UK, Ltd. 5, Marryat Close
Swedish: Storbritannien Brown & Burk UK, Ltd. 5, Marryat Close
Italian: Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2 - Vinohrady Czech Republic
Swedish: Slovakien Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2Vinohrady
Italian: 18 Km Marathon Avenue, 15351 Pallini Greece
Swedish: Grekland Genepharm S.A. 18 Km Marathon Avenue, 15351 Pallini
Italian: Panacea Biotec Germany GmbH
Swedish: Tyskland Panacea Biotec Germany GmbH
Italian: 71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania
Swedish: Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania
Italian: Teva Pharmaceuticals S.R.L. Str. Domniţa Ruxandra nr. 12, parter, sector 2, Bucureşti, România
Swedish: Str. Domniţa Ruxandra nr. 12, parter, sector 2, Bucureşti, România
Italian: Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Swedish: Huetteldorfer Straße 299 1140 Wien
Italian: Sandoz Pharma Services SRL Calea Floreasca Street No 169A, district 2
Swedish: Calea Floreasca Street No 169A, district 2
Italian: Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom
Swedish: Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT
Italian: Regno Unito Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Swedish: Storbritannien Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Italian: Lek farmacevtska družba d.d.
Swedish: Slovenien Lek farmacevtska družba d.d.
Italian: Sieger Pharma A.E. Marathonos Avenue 106 Pikermi 19009
Swedish: Grekland Sieger Pharma A.E. Marathonos Avenue 106
Italian: Alembic Pharmaceuticals Europe Limited Palazzo Pietro Stiges, 103, Strait Street
Swedish: Alembic Pharmaceuticals Europe Limited Palazzo Pietro Stiges, 103, Strait Street VLT 1436 Valletta Malta
Italian: 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom
Swedish: Redhill Surrey RH1 1FH United Kingdom
Italian: Clobazam CLOBAZAM AUDEN 10mg TABLETS
Swedish: CLOBAZAM AUDEN 10mg TABLETS
Italian: Metoclopramide METOCLOPRAMIDE ACCORD
Swedish: METOCLOPRAMIDE ACCORD
Italian: Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Swedish: Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Italian: Regno Unito Morningside Healthcare Limited
Swedish: Storbritannien Morningside Healthcare Limited
Italian: Mylan Pharmaceuticals, S.L. Plom 2-4, 5º Planta 8038 Barcelona Spain
Swedish: Plom 2-4, 5º Planta 8038 Barcelona Spain
Italian: Regno Unito Torrent Pharma GmbH Südwestpark 50
Swedish: Storbritannien Torrent Pharma GmbH Südwestpark 50
Italian: Generica KG Südwestpark 50
Swedish: Südwestpark 50
Italian: Regno Unito Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE
Swedish: Storbritannien Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE
Italian: Trimetazidina
Swedish: Trimetazidin
Italian: Valsartan/hydrochlorthiazi d "Fair-Med"
Swedish: Valsartan/hydrochlort hiazid "Fair-Med"
Italian: Teva Pharmaceuticals Slovakia s.r.o.
Swedish: Slovakien Teva Pharmaceuticals Slovakia s.r.o.
Italian: Wrexham Industrial Estate Wrexham LL13 9UF
Swedish: Wrexham LL13 9UF
Italian: Cipla Chanelle Generics Limited
Swedish: Cipla Chanelle Generics Limited Athenry Road,
Italian: Clobazam Clobazam Sandoz 10 mg, tabletten
Swedish: Clobazam Sandoz 10 mg, tabletten
Italian: Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
Swedish: Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF United Kingdom
Italian: Dosaggio Forma farmaceutica
Swedish: Läkemedelsform Administrationssätt
Italian: Tramadolo/paracet amolo
Swedish: Tramadol/paracetamol
Italian: EBASTINE BROWN & BURK 10 mg, comprimé Compressa orodispersibile
Swedish: EBASTINE BROWN & BURK 10 mg, comprimé orodispersible
Italian: H-4042 Debrecen Pallagi út 13.
Swedish: H-4042 Debrecen
Italian: Esomeprazole Mylan
Swedish: ESOMEPRAZOLO MYLAN
Italian: Northamptonshire NN8 6GT United Kingdom
Swedish: Northamptonshire NN8
Italian: Lambda Therapeutic Limited Sage House
Swedish: Lambda Therapeutic Limited
Italian: Venlafaxina cloridrato Venlafaxina Labesfal
Swedish: Venlafaxinhydroklorid Venlafaxina Labesfal
Italian: Ewopharma International s.r.o.,
Swedish: Ewopharma International s.r.o., Hlavna 13
Italian: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide 2790-012 Portela de Carnaxide
Swedish: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide
Italian: Clonazepam Clonazepam 500mcg Tablet
Swedish: Clonazepam 500mcg Tablet
Italian: Pensa Pharma S.P.A. Via Rossellini Ippolito, 12 20124 Milan
Swedish: Via Rossellini Ippolito, 12 20124 Milan
Italian: Desloratadine/Genepharm 5 mg δισκία επικαλυμμένα με υμένιο,
Swedish: Desloratadine/Geneph arm 5 mg δισκία επικαλυμμένα με υμένιο,
Italian: Acido alendronico ALENDRONATO RANBAXY ITALIA
Swedish: ALENDRONATO RANBAXY ITALIA
Italian: Accord Healthcare Limited Sage House, 319 Pinner Road
Swedish: Sage House, 319 Pinner Road
Italian: Medipha Sante Les Fjords - Immeuble Oslo 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Swedish: 19 avenue de Norvège 91953 Courtaboeuf Cedex
Italian: Nebivolol Inventis
Swedish: Nebivolol Inventis tablett
Italian: Valsartan/hydrochlorthiazi d "Fair-Med" Coated tablets
Swedish: Valsartan/hydrochlort hiazid "Fair-Med" Coated tablets
Italian: Acido alendronico Ácido alendrónico Labesfal
Swedish: Ácido alendrónico Labesfal
Italian: Goodwill Pharma Kft. H-6724 Szeged Cserzy Mihály u. 32.
Swedish: Grekland Goodwill Pharma Kft. H-6724 Szeged
Italian: Grange Road
Swedish: Grange Road Dublin 13
Italian: Sandoz Hungária Kft. H-1114 Budapest Bartók Béla út 43-47.
Swedish: Bartók Béla út 43-47.
Italian: Desloratadine/Genepharm 2,5 mg δισκία διασπειρόμενα στο στόμα
Swedish: Desloratadine/Geneph arm 2,5 mg δισκία διασπειρόμενα στο στόμα
Italian: Edíficio Arquiparque 1, R/C Esqº
Swedish: Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº
Italian: Cefpodoxima Alkaloid 200 mg Compressa
Swedish: Cefpodoxima Alkaloid 200 mg
Italian: Benjamin Franklinstraat 5-10 3261 LW Oud-Beyerland The Netherlands
Swedish: 3261 LW Oud-Beyerland The Netherlands
Italian: Clobazam Clobazam TioFarma 20 mg, tabletten
Swedish: Clobazam TioFarma 20 mg, tabletten
Italian: Nebivolol Labesfal
Swedish: Nebivolol Labesfal tablett
Italian: 83-200 Starogard Gdański Poland
Swedish: Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska 19 83-200 Starogard Gdański Poland
Italian: Germed Pharma S.P.A. Via Cantu', 11
Swedish: Via Cantu', 11
Italian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom
Swedish: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate
Italian: Bosentan monoidrato Bosentan Sandoz 125 mg
Swedish: Bosentanmonohydrat Bosentan Sandoz 125 mg
Italian: Gluforlyn XR 500 mg retard tabletta
Swedish: Metforminhydroklorid Gluforlyn XR 500 mg retard tabletta
Italian: Tacpan 1 mg Hartkapseln 1 mg
Swedish: Tacpan 1 mg Hartkapseln
Italian: Bosentan monoidrato Bosentan Sandoz 62,5 mg
Swedish: Bosentanmonohydrat Bosentan Sandoz 62,5 mg
Italian: Cefpodoxima
Swedish: Cefpodoxim
Italian: Desloratadine/Genepharm 5 mg δισκία διασπειρόμενα στο στόμα
Swedish: Desloratadine/Geneph arm 5 mg δισκία διασπειρόμενα στο στόμα
Italian: DE-22765 Hamburg
Swedish: D-22767 Hamburg
Italian: Bolamyn/Metabet SR 1000mg Prolonged Release Tablets
Swedish: Metforminhydroklorid Bolamyn/Metabet SR 1000mg Prolonged
Italian: Glenmark Pharmaceuticals s.r.o.
Swedish: Grekland Glenmark Pharmaceuticals s.r.o.
Italian: 1000 mg Compressa
Swedish: 1000 mg Depottablett
Italian: Valsartan 320mg Capsules 320 mg Capsula
Swedish: Valsartan 320mg Capsules
Italian: Athenry Road, Loughrea, Co Galway Ireland
Swedish: Loughrea, Co Galway Ireland
Italian: Levetiracetam Levetiracetam beta 1000 mg, Filmtabeltten
Swedish: Levetiracetam beta 1000 mg, Filmtabeltten
Italian: Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7 82031 Grünwald Germany
Swedish: Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7
Italian: Clobazam Clobazam TioFarma 10 mg, tabletten
Swedish: Clobazam TioFarma 10 mg, tabletten
Italian: Clonazepam Clonazepam TioFarma 0,5 mg tabletten, tabletten
Swedish: Clonazepam TioFarma 0,5 mg tabletten, tabletten
Italian: Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula
Swedish: Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Italian: STADA Hemofarm S.R.L. Calea Torontalului km 6PITT
Swedish: Calea Torontalului km 6PITT
Italian: Regno Unito Bluefish Pharmaceuticals AB Torsgatan 11
Swedish: Storbritannien Bluefish Pharmaceuticals AB Torsgatan 11
Italian: 15 mg Compressa gastroresistente
Swedish: 15 mg Gastroresistent tablett
Italian: Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Swedish: Edifícios AzevedosEstrada Nacional 117-2, Alfragide
Italian: Regno Unito Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Swedish: Storbritannien Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Italian: Acido alendronico ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Swedish: ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Italian: 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
Swedish: East Yorkshire HU17 0LD United Kingdom
Italian: Repubblica ceca Teva Pharmaceuticals CR, s.r.o.
Swedish: Teva Pharmaceuticals CR, s.r.o.
Italian: Bosentan monoidrato Bosentan Abdi 62,5 mg potahované tablety
Swedish: Bosentanmonohydrat Bosentan Abdi 62,5 mg potahované tablety
Italian: Levodopa/Carbidopa/Enta capone film-coated tablets 150/37.5/200mg mg/37,5 mg/200 mg
Swedish: Levodopa/Carbidopa/ Entacapone filmcoated tablets 150/37.5/200mg
Italian: Metoclopramidemonohydr ochloride Accord 10 mg, Tabletten
Swedish: Metoclopramidemono hydrochloride Accord 10 mg, Tabletten
Italian: Phenoxymethylpenicillin 250mg Film-coated Tablets
Swedish: Fenoxymetylpenicillin Phenoxymethylpenicill in 250mg Film-coated
Italian: Irbesartanas/Hidrochloroti azidas Torrent
Swedish: Irbesartanas/Hidrochl orotiazidas Torrent
Italian: Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula
Swedish: Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Italian: Alvogen IPCo S.àr.l.
Swedish: Slovakien Alvogen IPCo S.àr.l.
Italian: Clonazepam Clonazepam TioFarma 2 mg tabletten, tabletten
Swedish: Clonazepam TioFarma 2 mg tabletten, tabletten
Italian: TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Swedish: TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé
Italian: Acido alendronico Alendronat Accord Veckotablett
Swedish: Alendronat Accord Veckotablett
Italian: TRAMADOL PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Swedish: TRAMADOL PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé
Italian: Acido alendronico Acide Alendronique Ranbaxy 70 mg, comprimé
Swedish: Acide Alendronique Ranbaxy 70 mg, comprimé
Italian: Quetiapina
Swedish: Kvetiapin
Italian: Clonazepam Clonazepam Sandoz 0,5 mg, tabletten
Swedish: Clonazepam Sandoz 0,5 mg, tabletten
Italian: Metformin Actavis Retard 750 mg
Swedish: Metforminhydroklorid Metformin Actavis Retard 750 mg
Italian: Valsartan 160mg Capsules 160 mg Capsula
Swedish: Valsartan 160mg Capsules
Italian: 45 Rue de Fbg de Roubaix 59000 Lille
Swedish: ACCORD HEALTHCARE France SAS 45 Rue de Fbg de Roubaix
Italian: Donepezil/Generics
Swedish: Esomeprazole/ Generics
Italian: Peseri Trading Limited 20 Queen Frederica Street El-Greco House, office 301 1066 Nicosia Cyprus
Swedish: Peseri Trading Limited 20 Queen Frederica Street
Italian: Aleric Deslo Active
Swedish: Aleric Deslo Active 5 mg
Italian: 0,5 mg Tablet
Swedish: 2,5 mg Tablett
Italian: DONEPEZIL MYLAN GENERICS ITALIA
Swedish: Donepezilhydroklorid DONEPEZIL MYLAN GENERICS ITALIA
Italian: Desmopressina DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Swedish: DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Italian: Escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete
Swedish: Escitalopram PharmaS 10 mg filmom obložene tablete
Italian: Venlafaxine Fair-Med
Swedish: VENLAFAXINE FAIRMED
Italian: Acido alendronico alendronic acid 10mg Tablets
Swedish: Alendronsyra alendronic acid 10mg Tablets
Italian: Rizatriptan Mylan 5 mg 5 mg
Swedish: Rizatriptan Mylan 5 mg
Italian: Acido alendronico ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Swedish: ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Italian: Valsartan 80mg Capsules 80 mg Capsula
Swedish: Valsartan 80mg Capsules
Italian: Levodopa/carbidop a/entacapone
Swedish: Levodopa/karbidopa/en takapon
Italian: Acido alendronico alendronic acid 70mg Once Daily Tablets
Swedish: Alendronsyra alendronic acid 70mg Once Daily Tablets
Italian: Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene tablete mg/325 mg
Swedish: Tramadol/Paracetamo l PharmaS 37,5 mg/ 325 mg filmom obložene tablete
Italian: Landshuter Allee 8-10 D-80637 München Germany
Swedish: D-80637 München
Italian: Repubblica slovacca
Swedish: Slovakiska republiken
Italian: Irbesartan/idroclor otiazide
Swedish: Irbesartan/Hydrochlor othiazide
Italian: UE/SEE
Swedish: Medlemsstat (i EES)
Italian: Repubblica ceca Sandoz s.r.o.
Swedish: Sandoz s.r.o.
Italian: Tacpan 5 mg Hartkapseln 5 mg
Swedish: Tacpan 5 mg Hartkapseln
Italian: Metformin Actavis Retard 500 mg
Swedish: Metforminhydroklorid Metformin Actavis Retard 500 mg
Italian: Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
Swedish: Levetiracetam beta 750 mg, Filmtabletten
Italian: Bosentan monoidrato Bosentan Teva 125 mg potahované tablety
Swedish: Bosentanmonohydrat Bosentan Teva 125 mg potahované tablety
Italian: Regno Unito Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Swedish: Storbritannien Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF United Kingdom
Italian: 30 mg Compressa gastroresistente
Swedish: 30 mg Gastroresistent tablett
Italian: Bosentan monoidrato Bosentan Abdi 125 mg potahované tablety
Swedish: Bosentanmonohydrat Bosentan Abdi 125 mg potahované tablety
Italian: Desmopressina DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Swedish: DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Italian: Clonazepam Clonazepam Sandoz 2 mg, tabletten
Swedish: Clonazepam Sandoz 2 mg, tabletten
Italian: Acido alendronico Alendronat Ranbaxy Veckotablett 70 mg tabletter
Swedish: Alendronat Ranbaxy Veckotablett 70 mg tabletter
Italian: Valsartan/Hydrochlorothia zide Fair-Med 160 mg/12.5 mg film-coated tablets.
Swedish: Valsartan/Hydrochloro thiazide Fair-Med 160 mg/12.5 mg filmcoated tablets.
Italian: Metoclopramide cloridrato metoclopramide hydrochloride 10mg tablets
Swedish: Metoklopramidhydroklo rid metoclopramide hydrochloride 10mg tablets
Italian: Desmopressina DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Swedish: DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Italian: Fair-Med Healthcare GmbH Planckstrasse 13
Swedish: Fair-Med Healthcare GmbH
Italian: Metoclopramide Orifarm 10 mg Compressa
Swedish: Metoclopramide Orifarm 10 mg Tablett
Italian: Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
Swedish: Levetiracetam beta 250 mg, Filmtabletten
Italian: Capsula rigida Uso orale
Swedish: Enterokapsel, hård oral användning
Italian: Regno Unito Fair-Med Healthcare GmbH Planckstrasse 13
Swedish: Storbritannien Fair-Med Healthcare GmbH
Italian: Acido alendronico Alendronic Acid Once Weekly 70 mg Tablets
Swedish: Alendronic Acid Once Weekly 70 mg Tablets
Italian: Acido alendronico Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Swedish: Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Italian: DE-22765 Hamburg Germany irbesartan
Swedish: Planckstrasse 13 DE-22765 Hamburg Germany irbesartan
Italian: Escitalopram 20mg Filmcoated tablets
Swedish: Escitalopram 20mg Film-coated tablets
Italian: Donepezil Hydrochloride 5mg Orodispersible Tables
Swedish: Donepezilhydroklorid Donepezil Hydrochloride 5mg Orodispersible Tables
Italian: VALSARTAN/HIDROCLORO TIAZIDA CODRAMOL 160/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Swedish: VALSARTAN/HIDROCL OROTIAZIDA CODRAMOL 160/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Italian: Valsartan 40mg Capsules 40 mg Capsula
Swedish: Valsartan 40mg Capsules
Italian: Inaller 5 mg filmtabletta 5 mg
Swedish: Inaller 5 mg filmtabletta
Italian: Trimetazidina Mylan
Swedish: Trimetazidina Pharmakern
Italian: Ai pazienti e agli operatori sanitari vengono fornite le seguenti informazioni:
Swedish: Patienter och sjukvårdspersonal informeras om följande:
Italian: La raccomandazione del CHMP è stata trasmessa alla Commissione europea, per una decisione giuridicamente vincolante.
Swedish: CHMP:s rekommendation översändes till Europeiska kommissionen för ett rättsligt bindande beslut.
Italian: È questo l'esito di un riesame chiesto dai titolari dell'autorizzazione all'immissione in commercio per sette dei medicinali interessati.
Swedish: Detta är resultatet av en förnyad prövning som begärdes av innehavarna av godkännande för försäljning för sju av de berörda läkemedlen.
Italian: Il parere finale del CHMP è stato trasmesso alla Commissione europea, che in data 16 luglio 2015 ha emesso una decisione definitiva, giuridicamente vincolante, valida in tutti gli Stati membri dell'UE.
Swedish: CHMP:s slutliga yttrande översändes till Europeiska kommissionen, som den 16 juli 2015 utfärdade ett slutligt rättsligt bindande beslut som gäller i alla EU:s medlemsstater.
Italian: • I pazienti devono continuare ad assumere i medicinali come prescritto e contattare il medico o il farmacista per eventuali domande.
Swedish: • Patienterna ska fortsätta ta sina läkemedel enligt ordination och kontakta läkare eller apotekspersonal vid frågor.
Italian: L'ispezione ha rivelato manipolazioni dei dati degli elettrocardiogrammi (ECG) durante la conduzione di alcuni studi di generici, che sembrano essere avvenute nell'arco di almeno cinque anni.
Swedish: Vid inspektionen avslöjades datamanipulationer av elektrokardiogram (EKG) under utförandet av vissa studier av generiska läkemedel, något som verkar ha pågått i minst fem år.
Italian: Alcuni di questi medicinali possono rimanere in commercio in alcuni Paesi se essi sono d'importanza critica per i pazienti, poiché le alternative non sono in grado di soddisfare le esigenze dei pazienti.
Swedish: En del av dessa läkemedel kan komma att finnas kvar på marknaden i vissa länder om de är av kritisk betydelse för patienterna och inga andra alternativ kan fylla patienternas behov.
Italian: La natura sistematica di tali manipolazioni, il prolungato periodo durante il quale esse sono avvenute e il numero di componenti del personale coinvolti gettano dubbi sull'integrità della conduzione delle sperimentazioni presso il centro in generale e sull'affidabilità dei dati prodotti.
Swedish: Det systematiska genomförandet, den långa tid under vilken manipulationerna utförts och antalet anställda som var inblandade gav upphov till generella tvivel om utförandet av prövningar på anläggningen och tillförlitligheten hos resultaten av dessa.
Italian: L'EMA e le autorità nazionali lavorano a stretto contatto con i partner internazionali, per assicurare che gli studi alla base delle autorizzazioni all'immissione in commercio nell'UE siano eseguiti secondo i più elevati standard e che le aziende coinvolte rispettino pienamente tutti gli aspetti della buona pratica clinica (BPC).
Swedish: EMA och de nationella myndigheterna har ett nära samarbete med internationella partner för att se till att de studier som ligger till grund för godkännandena för försäljning i EU utförs enligt högsta standard och att företagen följer god klinisk sed i alla dess aspekter.
Italian: La decisione in merito alla criticità di un medicinale per i pazienti spetta alle autorità nazionali degli Stati membri dell'UE.
Swedish: Beslutet om huruvida ett läkemedel är av kritisk betydelse för patienterna eller inte åvilar de nationella myndigheterna i EU:s medlemsstater.
Italian: L'elenco aggiornato dei medicinali per i quali il CHMP ha raccomandato la sospensione è disponibile sul sito web dell'EMA.
Swedish: Den uppdaterade förteckningen över läkemedel för vilka CHMP rekommenderat tillfälligt upphävande finns på EMA:s webbplats.
Italian: • Alcuni medicinali considerati critici per i pazienti resteranno in commercio in alcuni Paesi in attesa della presentazione di nuovi dati.
Swedish: • En del läkemedel som anses vara mycket viktiga för patienterna kommer att finnas kvar på marknaden i vissa länder i avvaktan på nya data.
Italian: Per circa 300 ulteriori forme farmaceutiche e dosaggi erano stati forniti dati di supporto sufficienti; questi medicinali resteranno quindi in commercio nell'UE.
Swedish: 300 andra läkemedelsformer och -styrkor, varför dessa läkemedel kommer att finnas kvar på EUmarknaden.
Italian: In seguito alla richiesta di alcuni titolari dell'autorizzazione all'immissione in commercio, il CHMP ha riesaminato il parere del gennaio 2015.
Swedish: På begäran av några innehavare av godkännande för försäljning gjorde CHMP en förnyad prövning av sitt yttrande från januari 2015.
Italian: La Commissione ha formulato la sua decisione, valida per tutti gli Stati membri indipendentemente dall'eventuale adozione di misure provvisorie per la sospensione dei medicinali.
Swedish: Kommissionen har fattat sitt beslut, vilket gäller i alla medlemsstater oavsett om de har vidtagit interimsåtgärder för att tillfälligt upphäva godkännandena för försäljning av läkemedlen eller inte.
Italian: I medicinali considerati d'importanza critica per i pazienti resteranno disponibili
Swedish: Läkemedel som anses vara av kritisk betydelse för patienterna berörs inte
Italian: GVK Biosciences: L'Agenzia europea per i medicinali conferma la raccomandazione di sospendere i medicinali per difetti negli studi
Swedish: GVK Biosciences: Europeiska läkemedelsmyndigheten bekräftar rekommendationen om tillfälligt upphävande av godkännanden för försäljning på grund av bristfälliga studier
Italian: • Non vi sono prove di danno o di assenza di efficacia con alcuno dei medicinali, correlati agli studi condotti da parte di GVK Biosciences.
Swedish: • Det finns inga tecken på skador eller bristande effektivitet hos några av de läkemedel för vilka studierna utförts av GVK Biosciences.
Italian: Durante il riesame, il CHMP ha concluso che permangono i timori in merito all'affidabilità degli studi clinici e pertanto ha ribadito la raccomandazione del gennaio 2015 di sospendere i medicinali per cui non erano disponibili dati di supporto provenienti da altri studi.
Swedish: Vid den förnyade prövningen fann CHMP att farhågorna om de kliniska studiernas tillförlitlighet kvarstod, varför rekommendationen från januari 2015 om att tillfälligt upphäva godkännandet för försäljning för läkemedel som saknar understödjande data från andra studier fortfarande gäller.
Italian: Per i medicinali ritenuti critici, alle aziende vengono concessi 12 mesi per presentare dati supplementari.
Swedish: Företagen har beviljats en tidsfrist på 12 månader för att lämna in kompletterande data för de läkemedel som anses vara av kritisk betydelse.
Italian: Il prodotto è stato eliminato dall'elenco di medicinali di cui si raccomanda la sospensione.1
Swedish: Detta läkemedel togs bort från förteckningen över läkemedel för vilka tillfälligt upphävande rekommenderas.1
Italian: • Le autorità nell'UE considereranno il livello di criticità dei singoli medicinali nei rispettivi Paesi e adotteranno decisioni finali in merito all'eventualità di sospenderli o consentirne la disponibilità, in attesa della generazione di nuovi dati.
Swedish: • De nationella myndigheterna i EU kommer att bedöma hur viktiga de enskilda läkemedlen är i respektive land, och slutgiltigt besluta om godkännandena för dessa läkemedel tillfälligt ska upphävas eller om läkemedlen ska finnas kvar på marknaden medan nya data tas fram.