FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Ikke alle faser af undersøgelsen er udført hos GVK Bio: Til den oprindelige ansøgning havde indehaverne af markedsføringstilladelse udført en bioækvivalensundersøgelse, der sammenlignede det testede lægemiddel, natriumalendronat, tabletter, 70 mg, med det oprindelige europæiske præparat, Fosamax, tabletter, 70 mg, hos fastende raske mandlige forsøgspersoner.
Estonian: Esialgse taotluse esitamiseks viis müügiloa hoidja läbi bioekvivalentsusuuringu, milles võrreldi selle katseravimi Alendronate Sodium 70 mg tablette Euroopa uuendusliku ravimi Fosamax 70 mg tablettidega tervetel täiskasvanud meespatsientidel tühja kõhuga manustamise tingimustes.
Danish: CHMP traf derfor følgende konklusioner på grundlag af vurderingen af besvarelserne fra indehaverne af markedsføringstilladelse efter at have taget alle disses argumenter i behørig betragtning:
Estonian: Müügiloa hoidjate asjakohaste vastuste hindamise põhjal ja võttes nõuetekohaselt arvesse kõiki müügiloa hoidjate argumente, võttis inimravimite komitee vastu järgmised järeldused.
Danish: CHMP anerkender, at der ikke blev konstateret kritiske mangler ved en række revisioner foretaget af GVK's kunder eller ved inspektioner foretaget af de kompetente myndigheder hos GVK Bio i Hyderabad gennem en lang periode.
Estonian: Inimravimite komitee möönab, et GVK Bio Hyderabadi käitises viisid GVK kliendid pika aja jooksul läbi mitu auditit ja pädevad asutused tegid mitu kontrolli, avastamata olulisi tõendeid.
Danish: For lægemidler, der anses for kritisk nødvendige, kan suspenderingen af markedsføringstilladelsen i de pågældende medlemsstater udsættes i en periode af højst 24 måneder efter Kommissionens beslutning.
Estonian: Asjaomane liikmesriik (asjaomased liikmesriigid) võib (võivad) väga oluliseks peetava ravimi müügiloa (müügilubade) peatamise edasi lükata ajaks, mis ei tohi olla pikem kui 24 kuud alates Euroopa Komisjoni otsusest.
Danish: • CHMP finder bioækvivalensen fastlagrt for lægemidler i bilag IA (dvs. lægemidler indeholdende bendroflumethiazid, bosentan, fexofenadin, lansoprazol, levetiracetam, levocetirizin, metoclopramid, nebivolol og venlafaxin), for hvilke CHMP har modtaget, vurderet og godkendt enten andre bioækvivalensundersøgelser end den, der er udført på GVK Biosciences center i Hyderabad, eller påberåbelse af, at lægemidlerne opfylder kriterierne for dispensation for bioækvivalensundersøgelse baseret på biofarmaceutisk klassificering (BCS) som beskrevet i Appendix III til vejledningen om undersøgelser af bioækvivalens (CPMP/EWP/QWP/1401/98).
Estonian: • Seoses ravimitega (IA lisa), mille kohta esitati muud bioekvivalentsusuuringud kui GVK Bio Hyderabadi käitises tehtud uuring(ud) või väidetakse, et ravimid vastavad bioloogiliste ravimite klassifitseerimise süsteemil põhineva bioekvivalentsusuuringu nõudest loobumise kriteeriumidele, nagu on kirjeldatud bioekvivalentsusuuringute suunise (CHMP/EWP/QWP/1401/98) III lisas, ning mida inimravimite komitee hindas ja pidas positiivseks (st bendroflumetiasiidi, bosentaani, feksfenadiini, lansoprasooli, levetiratsetaami, levotsetirisiini, metoklopramiidi, nebivolooli ja venlafaksiini sisaldavad ravimid), on inimravimite komitee arvamusel, et bioekvivalentsus on tõestatud.
Danish: CVMP finder, at ovenstående argument fra markedsføringstilladelsesindehaverne må afvises, da det ikke kan træde i stedet for fastlæggelse af bioækvivalens med et EU-referencelægemiddel med henblik på en konklusion om et positivt benefit/risk-forhold for de omfattede lægemidler.
Estonian: Inimravimite komitee on arvamusel, et müügiloa hoidjate eespool esitatud argument ei asenda vajadust tõestada bioekvivalentsust ELis heakskiidetud võrdlusravimiga, et teha järeldus asjaomaste ravimite positiivse kasulikkuse ja riski suhte kohta, ning seetõttu tuleb see tagasi lükata.
Danish: Storbritannien Forum Products Limted Crown House
Estonian: Suurbritannia Forum Products Limted Crown House
Danish: 46015- Valencia (Valencia) Spain
Estonian: 46015- Valencia (Valencia)
Danish: Bilag I Liste over navne, lægemiddelforme, styrker ved lægemidlerne, administrationsmåder, indehavere af markedsføringstilladelsen i medlemslandene
Estonian: Lisa I Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
Danish: ACCORD HEALTHCARE France SAS
Estonian: Prantsusmaa ACCORD HEALTHCARE France SAS
Danish: Bulgarien Ecopharm Group AD bul.
Estonian: Ecopharm Group AD bul.
Danish: 300633 Timişoara
Estonian: 300633 Timişoara Romania
Danish: Storbritannien Chanelle Medical Dublin road
Estonian: Suurbritannia Chanelle Medical Dublin road
Danish: Calea Floreasca Street No 169A, district 2
Estonian: Calea Floreasca Street No 169A, district 2 Bucharest
Danish: Grækenland Pharmazac SA 31 Naoussis street Athens 1447
Estonian: Pharmazac SA 31 Naoussis street Athens 1447
Danish: Frankrig Plus Pharmacie SA 26 Boulevard Paul VaillantCouturier
Estonian: Prantsusmaa Plus Pharmacie SA 26 Boulevard Paul Vaillant-Couturier
Danish: Bulgarien Aquachim AD blvd. Prof. Tsvetan Lazarov
Estonian: Aquachim AD blvd. Prof. Tsvetan Lazarov
Danish: Spanien Aristo Pharma Iberia, S.L, c/ Solana, 26, Torrejon de Ardoz,
Estonian: Aristo Pharma Iberia, S.L, c/ Solana, 26, Torrejon de Ardoz,
Danish: Via dei Sabini, 28 63100 - Ascoli Piceno Italy
Estonian: Via dei Sabini, 28 63100 - Ascoli Piceno Italy venlafaksiin
Danish: P.O. Box 28629
Estonian: Box 28629
Danish: Østrig ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Estonian: Austria ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Danish: Tyskland Lannacher Heilmittel Ges.m.b.H.
Estonian: Lannacher Heilmittel Ges.m.b.H.
Danish: Storbritannien Teva UK Limited Brampton Road
Estonian: Suurbritannia Teva UK Limited Brampton Road
Danish: Bendroflumethiazid Bendroflumetiazid Alternova
Estonian: Bendroflumetiazid Alternova
Danish: 2770-071 Edificio D. Pedro I Paco de Arcos
Estonian: 2770-071 Edificio D. Pedro I
Danish: Cœur Défense - 100-110 Esplanade du Général de Gaulle
Estonian: Prantsusmaa Teva Sante Cœur Défense - 100-110 Esplanade du Général de Gaulle
Danish: Celon Pharma S.A. Ogrodowa 2A, Kiełpin 05-092 Łomianki, Poland
Estonian: Celon Pharma S.A. Ogrodowa 2A, Kiełpin 05-092 Łomianki, Poland bosentaan
Danish: Largo Donegani 4/A 28100 - Novara Italy
Estonian: Largo Donegani 4/A 28100 - Novara Italy venlafaksiin
Danish: Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK Ridings Point, Whistler Drive Castleford
Estonian: Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK Ridings Point, Whistler Drive
Danish: F-94200 Ivry-sur-Seine France
Estonian: F-94200 Ivry-sur-Seine France nebivolool
Danish: 11-15 Quai Dion Bouton 92800 Puteaux France
Estonian: 11-15 Quai Dion Bouton 92800 Puteaux
Danish: Storbritannien Waymade PLC Sovereign House Miles Grat Road, Basildon Essex SS14 3FR United Kingdom
Estonian: Waymade PLC Sovereign House Miles Grat Road, Basildon Essex SS14 3FR United Kingdom
Danish: Rumænien Torrent Pharma SRL Str. Stirbei Voda nr. 36 et. 2, biroul A, sector 1
Estonian: Torrent Pharma SRL Str. Stirbei Voda nr. 36 et. 2, biroul A, sector 1 Bucharest
Danish: 2081 Lefkosia
Estonian: 2081 Lefkosia Cyprus
Danish: Venipharm SAS 4 Bureaux de la Colline 92213 Saint-Cloud France
Estonian: Prantsusmaa Venipharm SAS 4 Bureaux de la Colline 92213 Saint-Cloud France
Danish: Wałbrzyska 13 60-198 Poznaň Poland
Estonian: Wałbrzyska 13 60-198 Poznaň Poland levotsetirisiin
Danish: Santa Eulalia, 240-242 L'Hospitalet de Llobregat 08902 Barcelona Spain
Estonian: Santa Eulalia, 240-242 L'Hospitalet de Llobregat 08902 Barcelona Spain venlafaksiin
Danish: 20 Balderton Street London W1K 6TL Untied Kingdom
Estonian: 20 Balderton Street London W1K 6TL Untied Kingdom lansoprasool
Danish: Desmopressin
Estonian: Desmopressiin
Danish: UAB Norameda Meistru 8a Vilnius LT-02189 Lithuania
Estonian: UAB Norameda Meistru 8a Vilnius LT-02189 Lithuania bosentaan
Danish: Laboratoires Biogaran 15, boulevard Charles de Gaulle
Estonian: Prantsusmaa Laboratoires Biogaran 15, boulevard Charles de Gaulle
Danish: Ljubljana SI-1000
Estonian: Ljubljana SI-1000 Slovenia
Danish: Sanofi Aventis France 1-13 bd Romain Rolland 75159 Paris Cedex 14 France
Estonian: Prantsusmaa Sanofi Aventis France 1-13 bd Romain Rolland 75159 Paris Cedex 14
Danish: Sussex BN22 9AG United Kingdom
Estonian: Sussex BN22 9AG United Kingdom feksofenadiin
Danish: Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2 - Vinohrady Czech Republic
Estonian: Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2Vinohrady
Danish: 319 Pinner Road, North Harrow
Estonian: Sage House 319 Pinner Road, North Harrow
Danish: Storbritannien Aptil Pharma Limited 9th Floor, CP House 97-107 Uxbridge Road London W5 5TL
Estonian: Aptil Pharma Limited 9th Floor, CP House 97-107 Uxbridge Road London W5 5TL United Kingdom
Danish: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta Madrid 28108
Estonian: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta
Danish: Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Estonian: Luksemburg Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Danish: Cherni vrah 14, bl.3
Estonian: Cherni vrah 14, bl.3 Sofia 1421
Danish: Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany
Estonian: Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany venlafaksiin
Danish: Fexofenadinhydrochlorid "Ivax"
Estonian: Fexofenadinhydrochlori d "Ivax"
Danish: Grækenland Genepharm S.A. 18 Km Marathon Avenue, 15351 Pallini
Estonian: 18 Km Marathon Avenue, 15351 Pallini Greece
Danish: Ulica grada Vukovara 226 F Zagreb 10000
Estonian: Ulica grada Vukovara 226 F
Danish: Zydus France Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Estonian: Prantsusmaa Zydus France Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Danish: Storbritannien FDC Pharma Unit 6, Fulcrum 1, Solent Way
Estonian: Unit 6, Fulcrum 1, Solent Way
Danish: Storbritannien Brown & Burk UK, Ltd. 5, Marryat Close
Estonian: Prantsusmaa Brown & Burk UK, Ltd. 5, Marryat Close
Danish: Rumænien Sandoz Pharma Services SRL
Estonian: Sandoz Pharma Services SRL
Danish: Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom
Estonian: Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT
Danish: Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal
Estonian: Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal
Danish: Farmaceutyczna Spółdzielnia Pracy Galena
Estonian: Farmaceutyczna Spółdzielnia Pracy Galena Krucza 62
Danish: Metforminhydrochlorid Bolamyn/Metabet SR 1000mg Prolonged
Estonian: Metformiinhüdrokloriid Bolamyn/Metabet SR 1000mg Prolonged
Danish: West Yorkshire WF10 5HX United Kingdom
Estonian: West Yorkshire WF10 5HX United Kingdom feksofenadiin
Danish: Medlemsland (i EØS)
Estonian: EL/EMP Liikmesriik
Danish: 71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania
Estonian: Dr. Reddy's Laboratories Romania SRL 71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania
Danish: 8502 Lannach Austria
Estonian: 8502 Lannach Austria nebivolool
Danish: Delorbis Pharmaceuticals Ltd 17 Athinon Street Ergates Industrial Area 2643 Ergates
Estonian: 17 Athinon Street Ergates Industrial Area 2643 Ergates P.O.
Danish: 20142 Milan Italy
Estonian: 20142 Milan Italy feksofenadiin
Danish: 71034 Böblingen Germany
Estonian: 71034 Böblingen Germany venlafaksiin
Danish: Storbritannien Morningside Healthcare Limited
Estonian: Suurbritannia Morningside Healthcare Limited
Danish: Grækenland Sieger Pharma A.E. Marathonos Avenue 106
Estonian: Sieger Pharma A.E. Marathonos Avenue 106 Pikermi 19009
Danish: 3771 ME Barneveld The Netherlands
Estonian: 3771 ME Barneveld The Netherlands feksofenadiin
Danish: Slovenien Lek farmacevtska družba d.d.
Estonian: Lek farmacevtska družba d.d.
Danish: DK-5260 Odense S Denmark
Estonian: DK-5260 Odense S Denmark feksofenadiin
Danish: Generis Farmacêutica, S. A. Rua João de Deus, 19 2700-487 Amadora Portugal
Estonian: Rua João de Deus, 19 2700-487 Amadora Portugal
Danish: Esomeprazolmagnesium ESOMEPRAZOLE/ GENERICS
Estonian: ESOMEPRAZOLE/ GENERICS
Danish: Tramadol/paracetamol
Estonian: Tramadool/paratsetamool
Danish: Frankrig ratiopharm GmbH Graf-Arco-Strasse 3
Estonian: Prantsusmaa ratiopharm GmbH Graf-Arco-Strasse 3
Danish: 22, quai Galliéni 92150 Suresnes France
Estonian: Prantsusmaa Cristers 22, quai Galliéni 92150 Suresnes France
Danish: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal
Estonian: Rua Henrique Paiva Couceiro, 29 - Venda Nova
Danish: São Martinho do Bispo 3045-016 Coimbra Portugal
Estonian: Bluepharma GenéricosComércio de Medicamentos, S.A. São Martinho do Bispo 3045-016 Coimbra Portugal venlafaksiin
Danish: Cefpodoxima Alkaloid 200 mg Tablet
Estonian: Cefpodoxima Alkaloid 200 mg Tablett
Danish: Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal
Estonian: Rua Alto do Montijo, 132º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal venlafaksiin
Danish: Cipla Chanelle Generics Limited Athenry Road,
Estonian: Cipla Chanelle Generics Limited
Danish: Bilag IA: Lægemidler, for hvilke markedsføringstilladelserne anbefales opretholdt Medlemsland (i EØS)
Estonian: IA lisa: Ravimid, mille müügiload soovitatakse säilitada EL/EMP
Danish: Rumænien STADA Hemofarm S.R.L.
Estonian: STADA Hemofarm S.R.L.
Danish: Rumænien Terapia SA Str. Fabricii nr. 124
Estonian: Terapia SA Str. Fabricii nr. 124 Cluj Napoca România venlafaksiin
Danish: BILAG IB: Lægemidler, for hvilke markedsføringstilladelserne anbefales suspenderet Medlemsland (i EØS)
Estonian: IB lisa: Ravimid, mille müügiload soovitatakse peatada EL/EMP
Danish: Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
Estonian: 577a Vouliagmenis Avenue Argyroupoli
Danish: Rumænien Abbott Products SAS 42 rue Rouget de Lisle 92150 Suresnes
Estonian: Prantsusmaa Abbott Products SAS 42 rue Rouget de Lisle 92150 Suresnes
Danish: Trimetazidin
Estonian: Trimetasidiin
Danish: Lambda Therapeutic Limited Sage House
Estonian: Lambda Therapeutic Limited
Danish: Esomeprazolmagnesium Esomylan 40 mg
Estonian: Esomylan 40 mg
Danish: Metoclopramide Orifarm 10 mg Tablet
Estonian: Metoclopramide Orifarm 10 mg Tablett
Danish: Metforminhydrochlorid Gluforlyn XR 500 mg retard tabletta
Estonian: Metformiinhüdrokloriid Gluforlyn XR 500 mg retard tabletta
Danish: Donepezilhydrochlorid DONEPEZIL MYLAN GENERICS ITALIA
Estonian: Donepesiilhüdrokloriid DONEPEZIL MYLAN GENERICS ITALIA
Danish: Irbesartanas/Hidrochlorot iazidas Torrent
Estonian: Irbesartanas/Hidrochlor otiazidas Torrent
Danish: Loughrea, Co. Galway Ireland
Estonian: Loughrea, Co. Galway Ireland feksofenadiin
Danish: Grange Road
Estonian: Grange Road Dublin 13
Danish: Entacapon
Estonian: Entakapoon
Danish: Storbritannien YJBPort Limited 74 Briarwood Drive Northwood Hills
Estonian: YJBPort Limited 74 Briarwood Drive Northwood Hills Middlesex HA6 1PL United Kingdom
Danish: Bulgarien Neo Balkanika EOOD 35 Zemliane Str.
Estonian: Neo Balkanika EOOD 35 Zemliane Str. Sofia 1618
Danish: Ropinirolhydrochlorid Ropinirole Lambda
Estonian: Ropinirool/hüdrokloriid Ropinirole Lambda
Danish: Valsartan/hydrochlorthiaz id "Fair-Med"
Estonian: Valsartan/hydrochlorthi azid "Fair-Med"
Danish: Metforminhydrochlorid Metformin Actavis Retard 750 mg
Estonian: Metformiinhüdrokloriid Metformin Actavis Retard 750 mg
Danish: Sweden
Estonian: Rootsi
Danish: Tacpan 1 mg Hartkapseln 1 mg
Estonian: Tacpan 1 mg Hartkapseln
Danish: 1 G. M. Dimitrov Blvd.
Estonian: 1 G. M. Dimitrov Blvd. Sofia 1172
Danish: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide
Estonian: Rua Alto do Montijo, 131º Dto - Edifício Monsanto Portela de Carnaxide 2790-012 Portela de Carnaxide
Danish: Ewopharma International s.r.o., Hlavna 13
Estonian: Ewopharma International s.r.o.,
Danish: Bosentanmonohydrat Bosentan Sandoz 62,5 mg
Estonian: Czech Republic bosentaan monohüdraat Bosentan Sandoz 62,5 mg
Danish: Edíficio Arquiparque 1, R/C Esqº
Estonian: Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº
Danish: Donepezilhydrochlorid Donezil
Estonian: Donepesiilhüdrokloriid Donezil
Danish: Desloratadine/Genephar m 5 mg δισκία επικαλυμμένα με υμένιο,
Estonian: Desloratadine/Genepha rm 5 mg δισκία επικαλυμμένα με υμένιο,
Danish: Desloratadine/Genephar m 2,5 mg δισκία διασπειρόμενα στο στόμα
Estonian: Desloratadine/Genepha rm 2,5 mg δισκία διασπειρόμενα στο στόμα
Danish: Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Estonian: 28108 Alcobendas (Madrid)
Danish: Levetiracetam LEVETIRACETAM MYLAN GENERICS
Estonian: LEVETIRACETAM MYLAN GENERICS
Danish: Venlafaxinhydrochlorid Venlafaxina Labesfal
Estonian: Portugal venlafaksiinvesinikkloriid Venlafaxina Labesfal
Danish: Medipha Sante Les Fjords - Immeuble Oslo 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Estonian: 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Danish: 1000 mg Tablet
Estonian: 1000 mg Tablett
Danish: Phenoxymethylpenicillin Phenoxymethylpenicillin 250mg Film-coated
Estonian: Fenoksümetüülpenitsilliin Phenoxymethylpenicillin 250mg Film-coated
Danish: Alendroninsyre alendronic acid 10mg Tablets
Estonian: Alendroonhape alendronic acid 10mg Tablets
Danish: Valsartan/hydrochlorthiaz id "Fair-Med" Coated tablets
Estonian: Valsartan/hydrochlorthi azid "Fair-Med" Coated tablets
Danish: Venlafaxina Bluefish
Estonian: Venlafaxina Bluepharma
Danish: Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene tablete
Estonian: Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene tablete mg/325 mg
Danish: Loughrea, Co Galway Ireland
Estonian: Athenry Road, Loughrea, Co Galway Ireland feksofenadiin
Danish: Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Estonian: Edifícios AzevedosEstrada Nacional 117-2, Alfragide
Danish: Storbritannien Dr Reddy's Laboratories (UK) Limited
Estonian: Dr Reddy's Laboratories (UK) Limited 6 Riverview Road, Beverley
Danish: ALENDRONATO AHCL 10 mg Tablet
Estonian: ALENDRONATO AHCL 10 mg Tablett
Danish: Metforminhydrochlorid Metformin Actavis Retard 500 mg
Estonian: Metformiinhüdrokloriid Metformin Actavis Retard 500 mg
Danish: Levetiracetam Levetiracetam beta 1000 mg, Filmtabeltten
Estonian: Levetiracetam beta 1000 mg, Filmtabeltten
Danish: Alendroninsyre alendronic acid 70mg Once Daily Tablets
Estonian: Alendroonhape alendronic acid 70mg Once Daily Tablets
Danish: Clindamycinhydrochlorid Clindamycin Alternova 150 mg Kapsel, hård Oral anvendelse
Estonian: Klindamütsiinhüdrokloriid Clindamycin Alternova 150 mg Kõvakapsel
Danish: 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
Estonian: East Yorkshire HU17 0LD United Kingdom
Danish: Rumænien Teva Pharmaceuticals S.R.L.
Estonian: Teva Pharmaceuticals S.R.L.
Danish: Desloratadine/Genephar m 5 mg δισκία διασπειρόμενα στο στόμα
Estonian: Desloratadine/Genepha rm 5 mg δισκία διασπειρόμενα στο στόμα
Danish: VALSARTAN/HIDROCLOR OTIAZIDA CODRAMOL 320/25 MG
Estonian: VALSARTAN/HIDROCLO ROTIAZIDA CODRAMOL 320/25 MG
Danish: 2,5 mg Tablet
Estonian: 2,5 mg Tablett
Danish: ALENDRONATO AHCL 70 mg Tablet
Estonian: ALENDRONATO AHCL 70 mg Tablett
Danish: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé
Estonian: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Danish: Cefpodoximproxetil
Estonian: Tsefpodoksiimproksetiil
Danish: VALSARTAN/HIDROCLOR OTIAZIDA CODRAMOL 160/25 MG
Estonian: VALSARTAN/HIDROCLO ROTIAZIDA CODRAMOL 160/25 MG
Danish: Trimetazidinhydrochlorid Vazidin 35 mg tablete s produljenim oslobađanjem
Estonian: Trimetasidiinhüdrokloriid Vazidin 35 mg tablete s produljenim oslobađanjem
Danish: Trimetazidinhydrochlorid Lupamadazine 35 mg Retardtabletten
Estonian: Trimetasidiinhüdrokloriid Lupamadazine 35 mg Retardtabletten
Danish: 0,5 mg Tablet
Estonian: 0,5 mg Tablett
Danish: Trimetazidinhydrochlorid Trimeluzine 35 mg tablete s podaljšanim sproščanjem
Estonian: Trimetasidiinhüdrokloriid Trimeluzine 35 mg tablete s podaljšanim sproščanjem
Danish: Tacpan 5 mg Hartkapseln 5 mg
Estonian: Tacpan 5 mg Hartkapseln
Danish: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé
Estonian: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Danish: Esomeprazolmagnesium Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula
Estonian: Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Danish: Donepezilhydrochlorid Donepezil/Generics
Estonian: Donepesiilhüdrokloriid DONEPEZIL/ GENERICS
Danish: Donepezilhydrochlorid DONEPEZIL/ GENERICS
Estonian: Donepesiilhüdrokloriid Donepezil/Generics
Danish: Storbritannien Bluefish Pharmaceuticals AB Torsgatan 11
Estonian: Suurbritannia Bluefish Pharmaceuticals AB
Danish: Storbritannien Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Estonian: Suurbritannia Lupin (Europe) Limited Victoria Court, Bexton Road
Danish: VALSARTAN ORION 320 mg Filmovertrukket tablet
Estonian: VALSARTAN ORION 320 mg Õhukese polümeerikattega tablett
Danish: 15 mg Gastroresistent tablet
Estonian: 15 mg Gastroresistentne tablett
Danish: Esomeprazolmagnesium Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula
Estonian: Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Danish: Levetiracetam Letiramyl 1000 mg potahované tablety
Estonian: Letiramyl 1000 mg potahované tablety
Danish: 750 mg Tablet
Estonian: 750 mg Tablett
Danish: Nebivolol
Estonian: Nebivolool
Danish: Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
Estonian: Levetiracetam beta 750 mg, Filmtabletten
Danish: Valsartan/Hydrochlorothi azide Fair-Med 160 mg/12.5 mg film-coated tablets.
Estonian: Valsartan/Hydrochlorot hiazide Fair-Med 160 mg/12.5 mg filmcoated tablets.
Danish: 200 mg Depottablet
Estonian: 200 mg Kõvakapsel
Danish: 250 mg Tablet
Estonian: 250 mg Tablett
Danish: 150 mg Depottablet
Estonian: 150 mg Kõvakapsel
Danish: Spanien RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura, 11
Estonian: RATIOPHARM ESPAÑA, S.A.
Danish: Esomeprazolmagnesium Neximyl 40 mg magensaftresistente Hartkapseln
Estonian: Neximyl 40 mg magensaftresistente Hartkapseln
Danish: 70 mg Tablet
Estonian: 70 mg Tablett
Danish: Clopidogrelhydrochlorid Clopidogrel 75mg filmcoated tablets
Estonian: Klopidogreelhüdrokloriid Clopidogrel 75mg filmcoated tablets
Danish: Esomeprazolmagnesium Neximyl 20 mg magensaftresistente Hartkapseln
Estonian: Neximyl 20 mg magensaftresistente Hartkapseln
Danish: Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
Estonian: Levetiracetam beta 250 mg, Filmtabletten
Danish: Donepezilhydrochlorid Donepezil Mylan 5 mg comprimate orodispersabile
Estonian: Donepesiilhüdrokloriid Donepezil Mylan 5 mg comprimate orodispersabile
Danish: Tablet med delekærv
Estonian: Õhukese polümeerikattega tablett
Danish: 20 mg Tablet
Estonian: 20 mg Tablett
Danish: Escitalopram 20mg Filmcoated tablets
Estonian: Escitalopram 20mg Film-coated tablets
Danish: Inaller 5 mg filmtabletta 5 mg
Estonian: Inaller 5 mg filmtabletta
Danish: Levetiracetam Levetiracetam-Hormosan 750 mg Filmtabletten
Estonian: LevetiracetamHormosan 750 mg Filmtabletten
Danish: Levetiracetam LEVETIRACETAM MYLAN PHARMA 1000mg, comprimé pelliculé
Estonian: LEVETIRACETAM MYLAN PHARMA 1000mg, comprimé pelliculé
Danish: Tlf. +44 (0) 20 3660 8427 E-mail: press@ema.europa.eu
Estonian: Tel +44 (0)2036608427 E-post: press@ema.europa.eu
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.
Estonian: Umbes 300 muu ravimvormi ja tugevuse kohta esitati piisavaid toetavaid andmeid muudest allikatest; need ravimid jäävad seega Euroopa Liidu turule.
Danish: For lægemidler, der betragtes som værende af kritisk betydning, gives virksomheder 12 måneder til at fremsende yderligere data.
Estonian: Kriitiliselt tähtsaks peetavate ravimite puhul on ettevõtetel 12 kuud aega lisaandmete esitamiseks.
Danish: CHMP's anbefaling blev fremsendt til Europa-Kommissionen for en juridisk bindende beslutning.
Estonian: Inimravimite komitee soovitus edastati Euroopa Komisjonile õiguslikult siduva otsuse tegemiseks.