FrancophonIA/ELRC3.0 huggingface dataset:
Czech: Výbor CHMP je tedy toho názoru, že při stanovování bioekvivalence s referenčním léčivým přípravkem registrovaným v EU se o tyto studie nelze opírat.
Latvian: Tāpēc CHMP uzskata, ka nevar atsaukties uz šiem pētījumiem, lai noteiktu bioekvivalenci attiecībā uz ES references zālēm.
Czech: Do této kategorie spadají přípravky, v souvislosti s nimiž držitelé rozhodnutí o registraci nepředložili žádnou žádost o výjimku ani studii bioekvivalence s referenčním léčivým přípravkem registrovaným v EU provedenou jinde než v zařízení společnosti GVK Biosciences Pvt. Ltd. v indickém Hyderabadu, a přípravky, v souvislosti s nimiž držitelé rozhodnutí o registraci neposkytli žádné odpovědi.
Latvian: Šajā kategorijā ir ietvertas zāles, kurām reģistrācijas apliecību īpašnieki nav iesnieguši jaunu bioekvivalences pētījuma pieprasījumu vai bioekvivalences pētījumu attiecībā uz ES references zālēm, kas veikts citur, nevis Haidarābādu GVK Biosciences Pvt.
Czech: Do této kategorie spadají léčivé přípravky, v souvislosti s nimiž držitelé rozhodnutí o registraci podali žádost o výjimku, tj.
Latvian: Šajā kategorijā ir ietvertas zāles, kurām reģistrācijas apliecības īpašnieki ir iesnieguši bioekvivalences pētījuma pieprasījumu [t.
Czech: Poměr přínosů a rizik přípravků uvedených v příloze IA zůstává příznivý, a výbor CHMP proto doporučuje registraci dotčených přípravků zachovat.
Latvian: pielikumā, saglabājas pozitīva, un CHMP iesaka saglabāt reģistrācijas apliecības šīm zālēm.
Czech: • Pokud jde o léčivé přípravky (příloha IA), k nimž byly předloženy jiné studie bioekvivalence než studie provedená/é na pracovišti společnosti GVK Biosciences v Hyderabadu nebo prohlášení, že léčivý přípravek splňuje na základě biofarmaceutického klasifikačního systému (BCS) kritéria pro výjimku, jak je popsáno v příloze III pokynu ke zkoumání bioekvivalence (CPMP/EWP/QWP/1401/98), které výbor CHMP posoudil a považoval za příznivé (tj.
Latvian: pielikumā), kurām tika iesniegti citi bioekvivalences pētījumi, nevis pētījumi, kas veikti Haidarābādu GVK Biosciences centrā, vai arī iesniegta prasība ievērot bioekvivalences kritērijus, kas atbilst biofarmaceitiskajai klasifikācijas sistēmai, kā aprakstīts Vadlīniju par bioekvivalences izpēti (CPMP/EWP/QWP/1401/98) III pielikumā, lai noteiktu bioekvivalenci attiecībā uz ES references zālēm, un un kuras CHMP novērtēja un atzina par pozitīvām (piemēram, zāles, kuras satur bendroflumetiazīdu, bosentānu, feksofenadīnu, lansoprazolu, levetiracetāmu, levocetirizīnu, metoklopramīdu, nebivololu un venlafaksīnu), CHMP uzskata, ka bioekvivalence ir pierādīta.
Czech: 46015- Valencia (Valencia) Spain
Latvian: 46015- Valencia (Valencia)
Czech: Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da
Latvian: Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha
Czech: Velká Británie Forum Products Limted Crown House
Latvian: Lielbritānija Forum Products Limted Crown House
Czech: Příloha I Seznam názvů léčivých přípravků, lékových forem, koncentrací, způsobů podání, držitelů rozhodnutí o registraci v členských státech
Latvian: Zāļu nosaukumi, zāļu formas, stiprumi, lietošanas veidi un reģistrācijas apliecību īpašnieki dalībvalstīs
Czech: Chorvatsko Belupo, lijekovi i kozmetika d.d.
Latvian: Belupo, lijekovi i kozmetika d.d.
Czech: Velká Británie Auden McKenzie Limited McKenzie House
Latvian: Lielbritānija Auden McKenzie Limited McKenzie House
Czech: Velká Británie Niche Generics Limited 1 The Cam Centre
Latvian: Lielbritānija Niche Generics Limited 1 The Cam Centre
Czech: Velká Británie Chanelle Medical Dublin road
Latvian: Lielbritānija Chanelle Medical Dublin road
Czech: Velká Británie Dr Reddy's Laboratories (UK) Limited
Latvian: Lielbritānija Dr Reddy's Laboratories (UK) Limited
Czech: 4510-688 Fânzeres
Latvian: 4510-688 Fânzeres Portugal
Czech: Rakousko ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Latvian: Austrija ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Czech: Cefpodoxim FOXERO
Latvian: Cefpodoksīm FOXERO
Czech: Nizozemsko Alembic Pharmaceuticals Europe Limited
Latvian: Nīderlande Alembic Pharmaceuticals Europe Limited
Czech: PŘÍLOHA IB: Přípravky, u kterých je doporučeno pozastavení rozhodnutí o registraci Členský stát
Latvian: IB pielikums: Zāles, kuru reģistrācijas apliecības tiek ieteikts apturēt Dalībvalsts
Czech: P.O. Box 28629
Latvian: Box 28629
Czech: Velká Británie FDC Pharma Unit 6, Fulcrum 1, Solent Way
Latvian: Lielbritānija FDC Pharma Unit 6, Fulcrum 1, Solent Way
Czech: Dr. Reddy's Laboratories Romania SRL
Latvian: Reddy's Laboratories Romania SRL
Czech: 1499-016 Algés
Latvian: 1499-016 Algés Portugal
Czech: Avenida Professor Doutor Cavaco Silva, n. 10E
Latvian: Avenida Professor Doutor Cavaco Silva, n. 10E Taguspark
Czech: ul. Kiełczowska 2 55-095 Mirków Poland
Latvian: Kiełczowska 2 55-095 Mirków Poland
Czech: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora
Latvian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Czech: Camí Real, 51-57, 08184 Palau-solita i Plegamans (Barcelona) Spain
Latvian: Camí Real, 51-57, 08184 Palau-solita i Plegamans (Barcelona)
Czech: Velká Británie Waymade PLC Sovereign House Miles Grat Road, Basildon Essex SS14 3FR United Kingdom
Latvian: Lielbritānija Waymade PLC Sovereign House Miles Grat Road, Basildon Essex SS14 3FR United Kingdom
Czech: 20 Balderton Street London W1K 6TL Untied Kingdom lansoprazol
Latvian: 20 Balderton Street London W1K 6TL Untied Kingdom lansoprazols
Czech: Chorvatsko Jadran Galenski Laboratorij d.d.
Latvian: Jadran Galenski Laboratorij d.d.
Czech: Velká Británie YJBPort Limited 74 Briarwood Drive Northwood Hills
Latvian: Lielbritānija YJBPort Limited 74 Briarwood Drive Northwood Hills
Czech: Velká Británie Teva UK Limited Brampton Road
Latvian: Lielbritānija Teva UK Limited Brampton Road
Czech: Largo Donegani 4/A 28100 - Novara Italy venlafaxin
Latvian: Largo Donegani 4/A 28100 - Novara Italy venlafaksīns
Czech: UAB Norameda Meistru 8a Vilnius LT-02189 Lithuania bosentan
Latvian: UAB Norameda Meistru 8a Vilnius LT-02189 Lithuania bosentāna
Czech: Viale Citta' D'Europa, 681 00144 Rome
Latvian: D'Europa, 681 00144 Rome
Czech: Velká Británie Aptil Pharma Limited 9th Floor, CP House 97-107 Uxbridge Road London W5 5TL
Latvian: Lielbritānija Aptil Pharma Limited 9th Floor, CP House 97-107 Uxbridge Road London W5 5TL
Czech: São Martinho do Bispo 3045-016 Coimbra
Latvian: São Martinho do Bispo 3045-016 Coimbra Portugal venlafaksīns
Czech: PŘÍLOHA IA: Přípravky, u kterých je doporučeno zachování rozhodnutí o registraci Členský stát
Latvian: Pielikums: Zāles, kuru reģistrācijas apliecības tiek ieteikts saglabāt Dalībvalsts
Czech: ul. Postępu 21B 02-676 Warszawa Poland
Latvian: Postępu 21B 02-676 Warszawa Poland
Czech: Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D-22767 Hamburg Germany levocetirizin
Latvian: Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1 D-22767 Hamburg Germany levocetirizine
Czech: Slovenia bosentan
Latvian: Slovenia bosentāna
Czech: Velká Británie Wockhardt UK Limited Ash Road North
Latvian: Lielbritānija Wockhardt UK Limited Ash Road North
Czech: Lucembursko Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Latvian: Luksemburga Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart
Czech: DK-4230 Skælskør Denmark bendroflumethiazid Bendroflumetiazid Alternova
Latvian: DK-4230 Skælskør Denmark bendroflumethiazide Bendroflumetiazid Alternova
Czech: Nizozemsko Unichem Laboratories Ltd.
Latvian: Nīderlande Unichem Laboratories Ltd.
Czech: ul. Bankowa 4
Latvian: Bankowa 4
Czech: 3771 ME Barneveld The Netherlands fexofenadin
Latvian: 3771 ME Barneveld The Netherlands fexofenadine
Czech: Portugalsko GP - Genéricos Portugueses, Lda.
Latvian: GP - Genéricos Portugueses, Lda.
Czech: Athenry Road, Loughrea, Co Galway Ireland fexofenadin
Latvian: Athenry Road, Loughrea, Co Galway Ireland fexofenadine
Czech: West Yorkshire WF10 5HX United Kingdom fexofenadin
Latvian: West Yorkshire WF10 5HX United Kingdom fexofenadine
Czech: 83-200 Starogard Gdański Poland fexofenadinhydrochlorid
Latvian: 83-200 Starogard Gdański Poland fexofenadine hidrohlorīds
Czech: 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom venlafaxinhydrochlorid
Latvian: 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom venlafaksīns hidrohlorīds
Czech: Czech Republic monohydrát bosentanu
Latvian: Czech Republic bosentāna monohidrāts
Czech: Sussex BN22 9AG United Kingdom fexofenadin
Latvian: Sussex BN22 9AG United Kingdom fexofenadine
Czech: Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany venlafaxin
Latvian: Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany venlafaksīns
Czech: Str. Domniţa Ruxandra nr. 12, parter, sector 2, Bucureşti, România
Latvian: 12, parter, sector 2, Bucureşti, România
Czech: Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom irbesartan
Latvian: Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom
Czech: Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park
Latvian: Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park
Czech: H-4042 Debrecen Pallagi út 13.
Latvian: Teva Gyógyszergyár Zrt. H-4042 Debrecen Pallagi út 13.
Czech: Velká Británie Morningside Healthcare Limited
Latvian: Lielbritānija Morningside Healthcare Limited
Czech: Ranbaxy Italia S.P.A.
Latvian: Ranbaxy Italia S.P.
Czech: Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7 82031 Grünwald Germany fexofenadin
Latvian: Dermapharm Aktiengesellschaft Lil-Dagover-Ring 7 82031 Grünwald Germany fexofenadine
Czech: Portugalsko Daquimed - Comércio de Produtos Farmacêuticos, S.A.
Latvian: Daquimed - Comércio de Produtos Farmacêuticos, S.A.
Czech: ul. Wałbrzyska 13 60-198 Poznaň Poland levocetirizin
Latvian: Wałbrzyska 13 60-198 Poznaň Poland levocetirizine
Czech: 71034 Böblingen Germany venlafaxin
Latvian: 71034 Böblingen Germany venlafaksīns
Czech: AAA-Pharma GmbH Liebknechstrasse 33 70565 Stuttgart Germany venlafaxin
Latvian: AAA-Pharma GmbH Liebknechstrasse 33 70565 Stuttgart Germany venlafaksīns
Czech: Velká Británie Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Latvian: Lielbritānija Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Czech: Via dei Sabini, 28 63100 - Ascoli Piceno Italy venlafaxin
Latvian: FB Health S.p.A. Via dei Sabini, 28 63100 - Ascoli Piceno Italy venlafaksīns
Czech: SE-104 35 Stockholm Sweden fexofenadin
Latvian: SE-104 35 Stockholm Sweden fexofenadine
Czech: 50-984 Wrocław Poland fexofenadinhydrochlorid
Latvian: 50-984 Wrocław Poland fexofenadine hidrohlorīds
Czech: Portugalsko Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Latvian: Eurogenus Farmacêutica, Sociedade Unipessoal, Lda.
Czech: Portugalsko Laboratórios AnovaProdutos Farmacêuticos, Lda.
Latvian: Laboratórios AnovaProdutos Farmacêuticos, Lda.
Czech: Abbott Laboratories Poland Sp. z o.o.
Latvian: Abbott Laboratories Poland Sp. z o.o. ul.
Czech: Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska
Latvian: Zakłady Farmaceutyczne POLPHARMA S.A.
Czech: Portugalsko Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Latvian: Pharmakern PortugalProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Czech: Portugal monohydrát bosentanu
Latvian: Portugal bosentāna monohidrāts
Czech: 11-15 Quai Dion Bouton 92800 Puteaux France venlafaxin
Latvian: 11-15 Quai Dion Bouton 92800 Puteaux France venlafaksīns
Czech: Farmalider, S.A. Aragoneses 15 28108 Madrid Spain
Latvian: Aragoneses 15 28108 Madrid Spain
Czech: Levodopa/karbidopa/ entakapon
Latvian: Levodopa/karbidopa/ entakapons
Czech: Hydrokortison
Latvian: Hidrokortizons
Czech: 1231 Ljubljana - Črnuče Slovenia levetiracetam Lyvam
Latvian: 1231 Ljubljana - Črnuče Slovenia levetiracetāms
Czech: Terapia SA Str. Fabricii nr. 124 Cluj Napoca România venlafaxin
Latvian: 124 Cluj Napoca România venlafaksīns
Czech: L'Hospitalet de Llobregat 08902 Barcelona
Latvian: L'Hospitalet de Llobregat 08902 Barcelona Spain venlafaksīns
Czech: Tactica Pharmaceuticals sp. z o.o.
Latvian: Tactica Pharmaceuticals sp. z o.o. ul.
Czech: Kyselina alendronová ALENDRONATO RANBAXY ITALIA
Latvian: ALENDRONATO RANBAXY ITALIA
Czech: GNR Czech s.r.o. Slavojova 579/9 128 00 Praha 2
Latvian: Slavojova 579/9 128 00 Praha 2
Czech: 20142 Milan Italy fexofenadin
Latvian: 20142 Milan Italy fexofenadine
Czech: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria bosentan
Latvian: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria bosentāna
Czech: Portugalsko Sandoz Farmaceutica Lda.
Latvian: Sandoz Farmaceutica Lda.
Czech: ESOMEPRAZOLE/ GENERICS
Latvian: Esomeprazolmagnijs ESOMEPRAZOLE/ GENERICS
Czech: Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide
Latvian: Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal venlafaksīns
Czech: Chorvatsko Fidifarm d.o.o.
Latvian: Fidifarm d.o.o.
Czech: 3752 LB Bunschoten The Netherlands fexofenadin
Latvian: 3752 LB Bunschoten The Netherlands fexofenadine
Czech: Fenoxymethylpenicilli n
Latvian: Fenoksimetilpenicilīn s
Czech: 02101 Espoo Finland venlafaxin
Latvian: 02101 Espoo Finland venlafaksīns
Czech: Kyselina alendronová Ácido alendrónico Accord
Latvian: Ácido alendrónico Accord
Czech: 92707 Colombes Cedex fexofenadin
Latvian: 92707 Colombes Cedex fexofenadine
Czech: 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
Czech: 1000 mg Tableta
Latvian: 1000 mg Tablete
Czech: 92931 La Défense Cedex France fexofenadin
Latvian: 92931 La Défense Cedex France fexofenadine
Czech: DK-5260 Odense S Denmark fexofenadin
Latvian: DK-5260 Odense S Denmark fexofenadine
Czech: S-Lab Sp. z o.o.
Latvian: S-Lab Sp. z o.o. ul.
Czech: Portugalsko Teva Pharma - Produtos Farmacêuticos,Lda.
Latvian: Teva Pharma - Produtos Farmacêuticos,Lda.
Czech: Slovakia fexofenadinhydrochlorid
Latvian: Slovakia fexofenadine hidrohlorīds
Czech: Nizozemsko TioFarma b.v.
Latvian: Nīderlande TioFarma b.v.
Czech: ul. Wałbrzyska 13 60-198 Poznaň Poland levocetirizinhydrochlorid
Latvian: Wałbrzyska 13 60-198 Poznaň Poland levocetirizine hidrohlorīds
Czech: Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º
Latvian: Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal
Czech: Cefpodoxim Forexo 200 mg comprimate filmate
Latvian: Cefpodoksīm Forexo 200 mg comprimate filmate
Czech: Couceiro, 29 - Venda Nova 2700-451 Amadora
Latvian: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal nebivolol
Czech: Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores
Latvian: José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal
Czech: 02101 Espoo Finland venlafaxinhydrochlorid
Latvian: 02101 Espoo Finland venlafaksīns hidrohlorīds
Czech: Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
Latvian: Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF
Czech: RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain nebivolol
Latvian: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid)
Czech: Kandesartan
Latvian: Kandesartāns
Czech: Klonazepam Clonazepam 500mcg Tablet
Latvian: Clonazepam 500mcg Tablet
Czech: Brown & Burk UK, Ltd. 5, Marryat Close Hounslow
Latvian: 5, Marryat Close Hounslow
Czech: 115 Narborough Road Leicester, LE3 0PA United Kingdom venlafaxinhydrochlorid
Latvian: 115 Narborough Road Leicester, LE3 0PA United Kingdom venlafaksīns hidrohlorīds
Czech: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal fexofenadin
Latvian: João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal fexofenadine
Czech: Loughrea, Co. Galway Ireland fexofenadin
Latvian: Galway Ireland fexofenadine
Czech: Spain fexofenadin
Latvian: Spain fexofenadine
Czech: 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
Czech: Chorvatsko Sandoz d.o.o.
Latvian: Sandoz d.o.o.
Czech: Kyselina alendronová Alendronat Accord Veckotablett
Latvian: Alendronat Accord Veckotablett
Czech: Celon Pharma S.A. Ogrodowa 2A, Kiełpin 05-092 Łomianki, Poland bosentan
Latvian: Ogrodowa 2A, Kiełpin 05-092
Czech: Slovakia fexofenadin
Latvian: Slovakia fexofenadine
Czech: Via Rossellini Ippolito, 12 20124 Milan
Latvian: Pensa Pharma S.P.A. Via Rossellini Ippolito, 12 20124 Milan
Czech: 02-954 Warszawa Poland lansoprazol
Latvian: 02-954 Warszawa Poland lansoprazols
Czech: Metoklopramidhydrochlorid metoclopramide hydrochloride 10mg tablets
Latvian: Metoklopramīda hidrohlorīds metoclopramide hydrochloride 10mg tablets
Czech: SE-11123 Stockholm Sweden venlafaxin
Latvian: SE-11123 Stockholm Sweden venlafaksīns
Czech: Via Cantu', 11
Latvian: Germed Pharma S.P.A. Via Cantu', 11
Czech: Dipyridamol
Latvian: Dipiridamols
Czech: Klonazepam Clonazepam 2mg Tablet 2 mg
Latvian: Clonazepam 2mg Tablet 2 mg
Czech: Velká Británie Bluefish Pharmaceuticals AB Torsgatan 11
Latvian: Lielbritānija Bluefish Pharmaceuticals AB Torsgatan 11
Czech: 117 allée des Parcs 69792 Saint-Priest Cedex France fexofenadin
Latvian: 117 allée des Parcs 69792 Saint-Priest Cedex France fexofenadine
Czech: 02-954 Warszawa Poland venlafaxin
Latvian: 02-954 Warszawa Poland venlafaksīns
Czech: 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
Czech: 90449 Nürnberg Germany venlafaxin
Latvian: 90449 Nürnberg Germany venlafaksīns
Czech: Pantoprazol
Latvian: Pantoprazols
Czech: Nizozemsko Apothecon B.V.
Latvian: Apothecon B.V.
Czech: Levetiracetam Levetiracetam beta 1000 mg, Filmtabeltten
Latvian: Levetiracetam beta 1000 mg, Filmtabeltten
Czech: Portugalsko Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Latvian: Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Czech: Escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete
Latvian: Escitalopram PharmaS 10 mg filmom obložene tablete
Czech: Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy
Czech: Portugal venlafaxinhydrochlorid
Latvian: Portugal venlafaksīns hidrohlorīds
Czech: Velká Británie Fair-Med Healthcare GmbH Planckstrasse 13
Latvian: Lielbritānija Fair-Med Healthcare GmbH Planckstrasse 13
Czech: Via Vittor Pisani, 20 20124 Milan Italy fexofenadin
Latvian: Via Vittor Pisani, 20 20124 Milan Italy fexofenadine
Czech: Nizozemsko Fair-Med Healthcare GmbH Planckstrasse 13
Latvian: Nīderlande Fair-Med Healthcare GmbH Planckstrasse 13
Czech: SE-11123 Stockholm Sweden venlafaxinhydrochlorid
Latvian: SE-11123 Stockholm Sweden venlafaksīns hidrohlorīds
Czech: Calea Torontalului km 6PITT
Latvian: STADA Hemofarm S.R.L. Calea Torontalului km 6PITT
Czech: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé
Latvian: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Czech: Cefpodoxim Trexodo 200 mg filmsko obložene tablete
Latvian: Cefpodoksīm Trexodo 200 mg filmsko obložene tablete
Czech: Klonazepam Clonazepam TioFarma 0,5 mg tabletten, tabletten
Latvian: Clonazepam TioFarma 0,5 mg tabletten, tabletten
Czech: Kyselina alendronová alendronic acid 70mg Once Daily Tablets
Latvian: Alendronskābe alendronic acid 70mg Once Daily Tablets
Czech: Kyselina alendronová ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Latvian: ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Czech: Klonazepam Clonazepam TioFarma 2 mg tabletten, tabletten
Latvian: Clonazepam TioFarma 2 mg tabletten, tabletten
Czech: Piazza Filippo Meda, 4, 3 20121 - Milano Italy lansoprazol
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy lansoprazols
Czech: Kyselina alendronová Acide Alendronique Ranbaxy 70 mg, comprimé
Latvian: Acide Alendronique Ranbaxy 70 mg, comprimé
Czech: Kyselina alendronová Ácido alendrónico Labesfal
Latvian: Ácido alendrónico Labesfal
Czech: Tramadol/paracetam ol
Latvian: Tramadols/ paracetamols
Czech: Telmisartan Dr. Reddy's 40 mg comprimate
Latvian: Reddy's 40 mg comprimate
Czech: Germany irbesartan
Latvian: Germany levetiracetāms
Czech: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé
Latvian: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Czech: Escitalopram Escitalopram Brown 5 mg
Latvian: Escitalopram Brown 5 mg
Czech: Piazza Filippo Meda, 4, 3 20121 - Milano Italy venlafaxin
Latvian: A. Piazza Filippo Meda, 4, 3 20121 - Milano Italy venlafaksīns
Czech: Klonazepam Clonazepam Sandoz 0,5 mg, tabletten
Latvian: Clonazepam Sandoz 0,5 mg, tabletten
Czech: Cefpodoxim Rexocef 200 mg filmom obložene tablete
Latvian: Cefpodoksīm Rexocef 200 mg filmom obložene tablete
Czech: Esomylan 40 mg
Latvian: Esomeprazolmagnijs Esomylan 40 mg
Czech: Cefpodoxim Cefpodoxima Alkaloid 200 mg
Latvian: Cefpodoxima Alkaloid 200 mg Tablete
Czech: Kyselina alendronová Alendronato Pensa 70 mg compresse
Latvian: Alendronato Pensa 70 mg compresse
Czech: Velká Británie Torrent Pharma GmbH Südwestpark 50
Latvian: Lielbritānija Torrent Pharma GmbH Südwestpark 50
Czech: Kyselina alendronová Alendronat Ranbaxy Veckotablett 70 mg tabletter
Latvian: Alendronat Ranbaxy Veckotablett 70 mg tabletter
Czech: Chorvatsko PharmaS d.o.o.
Latvian: PharmaS d.o.o.
Czech: Kyselina alendronová Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Latvian: Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Czech: Kyselina alendronová alendronic acid 10mg Tablets
Latvian: Alendronskābe alendronic acid 10mg Tablets
Czech: United Kingdom venlafaxinhydrochlorid
Latvian: United Kingdom venlafaksīns hidrohlorīds
Czech: Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Latvian: Esomeprazolmagnijs Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Czech: Telmisartan HCT Dr. Reddy's 80 mg/25 mg comprimate
Latvian: Reddy's 80 mg/25 mg comprimate
Czech: DK-5260 Odense S Denmark fexofenadinhydrochlorid
Latvian: DK-5260 Odense S Denmark fexofenadine hidrohlorīds
Czech: Kyselina alendronová Alendronic Acid Once Weekly 70 mg Tablets
Latvian: Alendronic Acid Once Weekly 70 mg Tablets
Czech: Kyselina alendronová ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Latvian: ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Czech: Telmisartan Dr. Reddy's 80 mg comprimate
Latvian: Reddy's 80 mg comprimate
Czech: Thiamin-hydrochlorid Tyvera 100mg Tablets 100 mg
Latvian: Tiamīna hidrohlorīds Tyvera 100mg Tablets 100 mg Tablete
Czech: Cyprus levocetirizinhydrochlorid
Latvian: Cyprus levocetirizine hidrohlorīds
Czech: Klopidogrel
Latvian: Klopidogrēls
Czech: 1 G. M. Dimitrov Blvd. Sofia 1172
Latvian: 1 G. M. Dimitrov Blvd.
Czech: Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
Latvian: Levetiracetam beta 750 mg, Filmtabletten
Czech: Nizozemsko Torrent Pharma GmbH Südwestpark 50
Latvian: Nīderlande Torrent Pharma GmbH Südwestpark 50
Czech: Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Latvian: Esomeprazolmagnijs Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Czech: Trimetazidin
Latvian: Trimetazidīns
Czech: Chorvatsko Alkaloid d.o.o.
Latvian: Alkaloid d.o.o.
Czech: Torrent Pharma SRL Str. Stirbei Voda nr. 36 et. 2, biroul A, sector 1 Bucharest
Latvian: Torrent Pharma SRL Str. Stirbei Voda nr.
Czech: Apo-trimetazidin 35 mg 35 mg
Latvian: Apo-trimetazidin 35 mg 35 mg Ilgstošās darbības tablete
Czech: Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
Latvian: Levetiracetam beta 250 mg, Filmtabletten
Czech: Klonazepam Clonazepam Sandoz 2 mg, tabletten
Latvian: Clonazepam Sandoz 2 mg, tabletten
Czech: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Latvian: Tālr.: +44 (0)20 3660 8427 E-pasts: press@ema.europa.eu
Czech: U dalších přibližně 300 lékových forem a sil byly předloženy dostatečné podpůrné údaje z jiných zdrojů, tyto léčivé přípravky proto zůstávají na trhu v EU.
Latvian: Aptuveni 300 citām zāļu formām un stiprumiem tika sniegti pietiekami atbalstoši dati no citiem avotiem, tāpēc šīs zāles paliek ES tirgū.
Czech: Doporučení výboru CHMP bylo zasláno Evropské komisi, aby vydala právně závazné rozhodnutí.
Latvian: CHMP ieteikums tika nosūtīts Eiropas Komisijai likumīgi saistoša lēmuma pieņemšanai.