FrancophonIA/ELRC3.0 huggingface dataset:
English: FENOFIBRATE EXPANPHARM 200 mg, comprimé tablet
Maltese: FENOFIBRATE EXPANPHARM 200 mg, comprimé
English: Leurquin Mediolanum Lab. 68-88, rue Ampere (Z.I.
Maltese: Leurquin Mediolanum Lab. 68-88, rue Ampere (Z.I. Chanaux) 93330 Neuilly-sur-Seine France
English: FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
Maltese: FENOFIBRATE RATIOPHARM 160 mg, comprimé
English: LIPIPHARM 145 mg, comprimé tablet
Maltese: LIPIPHARM 145 mg, comprimé
English: HYPERLIPEN 100 MG
Maltese: HYPERLIPEN 100
English: BEZAFIBRAT SLAVIA 200 mg tablets
Maltese: BEZAFIBRAT SLAVIA 200 mg
English: CIPROFIBRATE MYLAN 100 MG
Maltese: CIPROFIBRATE MYLAN 100
English: S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca Romania
Maltese: Fabricii Nr. 124 Cluj-Napoca Romania
English: FENOFIBRATE QUALIMED 145 mg, comprimé tablet
Maltese: FENOFIBRATE QUALIMED 145 mg, comprimé
English: IPOLIPID CAPSULES 600mg 600mg capsules
Maltese: IPOLIPID CAPSULES 600mg 600mg
English: FENOFIBRATE ALTER 160 mg, comprimé tablet
Maltese: FENOFIBRATE ALTER 160 mg, comprimé
English: BEZAFIBRATE 200MG TABLETS
Maltese: TABLETS 200MG
English: FENOFIBRATE TEVA 160 mg, comprimé tablet
Maltese: FENOFIBRATE TEVA 160 mg, comprimé
English: FENOFIBRATE SANDOZ 145 mg, comprimé tablet
Maltese: FENOFIBRATE SANDOZ 145 mg, comprimé
English: FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
Maltese: FR - Franza Actavis Group PTC ehf Reykjavikurvegi 76-78
English: FENOFIBRATE SANDOZ 200 MG
Maltese: FENOFIBRATE SANDOZ 200
English: FENOGAL 267 MG LIDOSE 267 mg capsule hard
Maltese: FENOGAL 267 MG LIDOSE 267 mg
English: Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Maltese: Lipantil Supra 145mg filmcoated tablets
English: HUHungary
Maltese: HUUngerija
English: FENOFIBRATE CRISTERS 160 mg, comprimé tablet
Maltese: FENOFIBRATE CRISTERS 160 mg, comprimé
English: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten prolonged-release tablet
Maltese: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten
English: FENOFIBRAT TERAPIA 200 mg capsules
Maltese: FENOFIBRAT TERAPIA 200 mg
English: FENOFIBRATE WINTHROP 145 mg, comprimé tablet
Maltese: FENOFIBRATE WINTHROP 145 mg, comprimé
English: ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
Maltese: ET - Estonja Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000
English: Gemfibrozil 600 PCH, omhulde tabletten 600 mg, RVG 25031
Maltese: PCH, omhulde tabletten 600 mg, RVG 25031
English: FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Maltese: FENOFIBRATE ACTAVIS 160 mg, comprimé
English: S.C. TERAPIA S.A. Str. Fabricii Nr. 124, Cluj-Napoca România
Maltese: Fabricii Nr. 124, Cluj-Napoca România
English: Lipantil Micro 200 mg capsules, hard hard capsules
Maltese: Lipantil Micro 200 mg capsules, hard
English: FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
Maltese: FENOFIBRATE BIOGARAN 145 mg, comprimé
English: Box 42
Maltese: Boulevard 40
English: FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
Maltese: FENOFIBRATE BIOGARAN 160 mg, comprimé
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
Maltese: LTD, 1-10 Constantinoupoleos street P.O.Box 51409
English: Lipantil Supra 160mg filmcoated tablets film-coated tablets oral use
Maltese: Lipantil Supra 160mg filmcoated tablets
English: FENOFIBRATE MYLAN 145 mg, comprimé tablet
Maltese: FENOFIBRATE MYLAN 145 mg, comprimé
English: Bezalip® Retard depo tablet
Maltese: Pilloli li għandhom effett fit-tul
English: Lipantil Supra 215mg filmcoated tablets film-coated tablets oral use
Maltese: Lipantil Supra 215mg filmcoated tablets
English: Lopid 300 mg capsules hard capsules
Maltese: Lopid 300 mg capsules
English: FENOFIBRATE RANBAXY 160 mg, comprimé tablet
Maltese: FENOFIBRATE RANBAXY 160 mg, comprimé
English: FENOFIBRATE ARROW 160 mg, comprimé tablet
Maltese: FENOFIBRATE ARROW 160 mg, comprimé
English: Telecom Gardens Medialaan 40
Maltese: BE - Belġju SANDOZ N.V. Telecom Gardens Medialaan 40
English: S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca România
Maltese: Fabricii Nr. 124 Cluj-Napoca România
English: capsule, hard
Maltese: Kapsuli, iebsa
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
Maltese: LTD 1-10 Constantinoupoleos street, P.O.Box 51409
English: 2333 CR Leiden The Netherlands
Maltese: 2333 CR Leiden
English: FENOFIBRATE SANDOZ 160 mg, comprimé tablet
Maltese: FENOFIBRATE SANDOZ 160 mg, comprimé
English: MT - Malta Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2
Maltese: KG Liebigstrasse 1-2
English: Laboratoires Fournier SA 8 Bd Clemenceau F-21000 Dijon France
Maltese: Laboratoires Fournier SA 8 Bd Clemenceau F-21000
English: FR - France GALENIX DEVELOPPEMENT Les Palanques
Maltese: FR - Franza GALENIX
English: TABLET
Maltese: Pillola
English: Pfizer B.V.
Maltese: NL - Olanda Pfizer B.V. Rivium
English: Lipantil Micro 267 mg capsules, hard hard capsules
Maltese: Lipantil Micro 267 mg capsules, hard
English: Lipantil Micro 67 mg capsules, hard hard capsules
Maltese: Lipantil Micro 67 mg capsules, hard
English: IT - Italy Solvay Pharma Spa Via della Libertà 30
Maltese: IT - Italja Solvay Pharma Spa
English: LIPOFOR CAPSULES 300mg 300mg capsules
Maltese: LIPOFOR CAPSULES 300mg 300mg
English: FENOFIBRAAT EG 200 MG 200 mg
Maltese: FENOFIBRAT LPH 200 mg 200 mg
English: FENOFIBRATE EG 145 mg, comprimé tablet
Maltese: FENOFIBRATE EG 145 mg, comprimé
English: Lipcor 200 mg - Kapseln 200 mg capsule, hard
Maltese: Lipcor 200 mg - Kapseln 200 mg
English: hard capsule
Maltese: Kapsuli iebsa
English: AT - Austria Actavis Group PTC ehf Reykjavikurvegur 76-78
Maltese: AT - Awstrija Actavis Group PTC ehf Reykjavikurvegur 76-78
English: FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
Maltese: FR - Franza Biogaran15 bd Charles de Gaulle 92700 Colombes France
English: RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Maltese: RORumanija sanofi-aventis france 1-13, boulevard Romain Rolland 75014
English: FENOFIBRATE EG 160 mg, comprimé pelliculé tablet
Maltese: FENOFIBRATE EG 160 mg, comprimé pelliculé
English: Laboratoires Fournier SA 28 Boulevard Clemenceau 21000 Dijon
Maltese: Laboratoires Fournier SA 28 Boulevard Clemenceau 21000
English: LIPOHEXAL 250 RETARD 250MG
Maltese: LIPOHEXAL 250
English: IT - Italy Francia Farmaceutici Industria Farmaco Biologica Srl
Maltese: IT - Italja Francia Farmaceutici
English: IPOLIPID CAPSULES 300mg 300mg capsules
Maltese: IPOLIPID CAPSULES 300mg 300mg
English: FENOFIX 200 MG
Maltese: FENOX 160 mg
English: Lipsin 100 mg - Kapseln 100 mg capsule, hard
Maltese: Lipsin 100 mg - Kapseln 100 mg
English: LIPILFEN 160 mg, comprimé tablet
Maltese: LIPILFEN 160 mg, comprimé
English: CIPROFIBRATE 100MG TABLETS
Maltese: CIPROFIBRATE 100MG
English: FENOFIBRATE MYLAN 200 MG MICRONISED
Maltese: FENOFIBRATE MYLAN 200
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Maltese: FR - Franza SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014
English: LIPANTHYL NT 145 mg 145 mg
Maltese: LIPANTHYL NT 145 MG 145
English: FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Maltese: FR - Franza Mylan SAS 117, allée des Parcs 69800 Saint Priest France
English: FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Maltese: FENOFIBRATE WINTHROP 160 mg, comprimé
English: Gemfibrozil Sandoz filmcoated tablet
Maltese: Gemfibrozil Sandoz
English: Eulitop tablet
Maltese: Pillola miksija
English: LV - Latvia Laboratoires Fournier S.A. Boulevard Clemenceau 28
Maltese: LV - Latvja Laboratoires Fournier S.A.
English: S.C. SLAVIA PHARM S.R.L.
Maltese: S.C. ARENA GROUP S.A. Str.
English: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Maltese: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220
English: 20014 MILANO
Maltese: MILANO Italy
English: Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
Maltese: Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220
English: FR - France Biogaran 15, bd Charles de Gaulle 92700 Colombes France
Maltese: FR - Franza Biogaran 15, bd Charles de Gaulle 92700 Colombes France
English: Fenobrat prolonged-release capsule
Maltese: MG/CAP Kapsuli iebsa
English: 100MG capsule, hard
Maltese: 100MG Kapsula, iebsa
English: Capsules, hard
Maltese: Kapsula, iebsa
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
Maltese: FR - Franza BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
English: FI - Finland Actavis Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Maltese: FI - Finlandja Actavis Actavis Group PTC ehf Reykjavikurvegi 76-78 220
English: FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
Maltese: FR - Franza Actavis Group PTC ehfReykjavikurvegi 76-78220
English: 160 MG/CAP HARD CAPSULES ORAL
Maltese: 160 MG/CAP Kapsuli iebsa
English: Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugal
Maltese: Edifício 7 - 2º/3º 2740-264
English: Fenofibrat 200 Heumann 200 mg
Maltese: Heumann 200 mg
English: FR - France Qualimed 117, allée des Parcs 69800 Saint Priest France
Maltese: FR - Franza Qualimed 117, allée des Parcs 69800 Saint Priest France
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest FRANCE
Maltese: FR - Franza QUALIMED 117, allée des Parcs 69800 Saint-Priest FRANCE
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
Maltese: FR - Franza QUALIMED 117, allée des Parcs 69800 Saint-Priest France
English: FENOFIBRATE ALMUS 67 mg, gélule
Maltese: ALMUS 67 mg, gélule
English: FENOFIBRATE ZYDUS 67 mg, gélule
Maltese: ZYDUS 67 mg, gélule
English: LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau 21000 Dijon
Maltese: LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau 21000
English: Wörwag Pharma GmbH & Co. KG Calwer Str. 7
Maltese: Wörwag Pharma GmbH & Co.
English: GEMFIBROZILO FERMON 900 mg film coated tablets oral
Maltese: GEMFIBROZILO FERMON 900 mg
English: BEZAFIBRATE TABLETS 200MG
Maltese: BEZAFIBRATE 200MG
English: BEBelgium
Maltese: Brussels Belgium
English: LIPANTHYL S 215 MG 215 MG
Maltese: LIPANTHYL SUPRA 215 mg 215 mg
English: GEMFIBROZILO FERMON 600 mg film coated tablets oral
Maltese: GEMFIBROZILO FERMON 600 mg
English: FENOFIBRATE ALMUS 160 mg, comprimé tablet
Maltese: ALMUS 160 mg, comprimé
English: FENOFIBRATE ALMUS 200 mg, gélule
Maltese: ALMUS 200 mg, gélule
English: LABORATOIRES FOURNIER S.A. 28 Bd. Clemenceau 21000 Dijon
Maltese: LABORATOIRES FOURNIER S.A. 28 Bd. Clemenceau 21000
English: Laboratoires FOURNIER S.A. 28Bd Clemenceau 21000 Dijon
Maltese: Laboratoires FOURNIER S.A. 28Bd Clemenceau 21000
English: Mylan B.V.
Maltese: NL - Olanda Mylan B.V. Dieselweg 25
English: FENOFIBRATO RANBAXY 160mg film coated tablets oral
Maltese: FENOFIBRATO RANBAXY 160mg
English: LIPOFIB 160 mg capsules
Maltese: LIPOFIB 160 mg
English: FENOFIBRATE ZYDUS 200 mg, gélule
Maltese: ZYDUS 200 mg, gélule
English: 11 September 2012
Maltese: 11 ta' Settembru 2012
English: EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
Maltese: EMA/410788/2012 Rev.
English: Mifepristone Linepharma is a ‘hybrid medicine'.
Maltese: Mifepristone Linepharma huwa ‘mediċina ibrida'.
English: Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Maltese: Mifepristone Linepharma huwa diġà awtorizzat permezz ta' proċedura deċentralizzata fid-Danimarka, fil-Finlandja, fl-Islanda, fin-Norveġja u fl-Isvezja.
English: What is Mifepristone Linepharma?
Maltese: X'inhu Mifepristone Linepharma?
English: Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 - 48 hours later by a dose of another medicine called gemeprost.
Maltese: Mifepristone Linepharma jingħata bħala doża waħda ta' 200 mg, segwita bejn 36 u 48 siegħa wara minn doża ta' mediċina oħra msejħa gemeprost.
English: Linepharma France submitted an application for Mifepristone Linepharma for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 December 2010.
Maltese: Linepharma France issottomettiet applikazzjoni għal Mifepristone Linepharma għar-rikonoxximent reċiproku fuq il-bażi tal-awtorizzazzjoni inizjali mogħtija mill-Isvezja fit-3 ta' Diċembru 2010.
English: Both medicines are available as 200 mg tablets but whereas Mifegyne was authorised to be given at doses of 600 mg and 200 mg, Mifepristone Linepharma was only authorised at the 200 mg dose.
Maltese: Iż-żewġ mediċini huma disponibbli bħala pilloli ta' 200 mg iżda filwaqt li Mifegyne kien awtorizzat sabiex jingħata f'dożi ta' 600 mg u 200 mg, Mifepristone Linepharma kien awtorizzat biss fid-doża ta' 200 mg.
English: On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mifepristone Linepharma.
Maltese: Fil-21 ta' Ġunju 2012, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Mifepristone Linepharma.
English: This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' msejħa Mifegyne li fiha l-istess sustanza attiva.
English: The CHMP noted that the data submitted by the company showed a small deviation of Mifepristone Linepharma from the acceptable range for bioequivalence with the reference medicine, with Mifepristone Linepharma 200 mg producing slightly higher levels of active substance in the body than Mifegyne 200 mg.
Maltese: Is-CHMP innota li d-dejta ppreżentata mill-kumpanija uriet devjazzjoni żgħira ta' Mifepristone Linepharma mill-medda aċċettabbli għal bijoekwivalenza mal-mediċina ta' referenza, b'Mifepristone Linepharma 200 mg jipproduċi livelli kemmxejn ogħla tas-sustanza attiva fil-ġisem milli Mifegyne 200 mg. Madankollu, id-differenza ma kinitx ikkunsidrata ta' tħassib minħabba li s-sigurtà u l-effikaċja ta' mifepristone f'dożi ferm ogħla sa 600 mg huma stabbiliti sew u ġew ikkonfermati mill-istudji ta' appoġġ b'Mifepristone Linepharma.
English: Why was Mifepristone Linepharma reviewed?
Maltese: Għalxiex ġie rivedut Mifepristone Linepharma?
English: However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal qbil u l-aġenzija regolatorja tal-mediċini Franċiża rreferiet il-kwistjoni lis-CHMP għall-arbitraġġ fit-23 ta' Frar 2012.
English: The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Maltese: Ilkumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta fi Franza u fir-Renju Unit (l-‘Istati Membri kkonċernati').
English: It contains the active substance mifepristone, which works by blocking the effects of the hormone progesterone, which plays an important role in the maintenance of pregnancy.
Maltese: Fih is-sustanza attiva mifepristone, li taħdem billi timblokka l-effetti tal-ormon proġesteron, li għandu rwol importanti fiżżamma tat-tqala.
English: The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg.
Maltese: Ir-raġunijiet għar-riferiment kienu li Mifepristone Linepharma ma ntweriex li kien bijoekwivalenti għallmediċina ta' referenza, Mifegyne 200 mg.
English: Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Mifepristone Linepharma outweigh its risks and recommended that the marketing authorisation for Mifepristone Linepharma be granted in all concerned Member States.
Maltese: Barra minn hekk, ilKumitat irrakkomanda li għandu jsir studju ta' osservazzjoni prospettiva sabiex ikun immonitorjat kif jinkitbu r-riċetti b'Mifepristone Linepharma.
English: Mifepristone Linepharma is a medicine used for terminating pregnancy.
Maltese: Mifepristone Linepharma huwa mediċina użata biex titwaqqaf it-tqala.
English: Veterinary Medicines
Maltese: Mediċini Veterinarji
English: International non-proprietary name (INN): enrofloxacin
Maltese: Isem mhux proprjetarji internazzjonali (INN): enrofloxacin
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Maltese: Enrofloxacin huwa aġent kimoterapewtiku sintetiku mill-klassi tad-derivattivi fluoroquinolone carboxylic-acid.
English: The referral started on 7 November 2012.
Maltese: Ir-riferiment inbeda fis-7 ta' Novembru 2012.
English: The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Maltese: Il-Kumitat ħatar lil H. Jukes bħala rapporteur u lil E-M. Vestergaard bħala ko-rapporteur.
English: 28 February 2014
Maltese: 28 ta' Frar 2014
English: Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Maltese: Ġew ipprovduti spjegazzjonijiet bil-miktub mill-applikanti u middetenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fil-15 ta' Frar 2013 u d-9 ta' Settembru 2013.
English: On 18 October 2012, the United Kingdom presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys.
Maltese: Fit-18 ta' Ottubru 2012, ir-Renju Unit ippreżenta lill-Aġenzija, notifika ta' riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE, dwar il-prodotti mediċinali kollha li fihom enrofloxacin li għandu jingħata permezz tal-ilma tax-xorb lit-tiġieġ u/jew id-dundjani.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Maltese: Għandu attività antibatterika kontra firxa wiesgħa ta' batterji Gram-negattivi u Grampożittivi. Enrofloxacin huwa għall-użu veterinarju biss.
English: The CVMP was requested to consider the indications, dosage regimens and withdrawal periods for chickens and turkeys in order to ensure consumer safety, efficacious treatment in chickens and turkeys, as well as lower the risk of development of antimicrobial resistance to enrofloxacin.
Maltese: Is-CVMP intalab jikkunsidra l-indikazzjonijiet, irreġimi ta' dożaġġ u l-perjodi ta' rtirar għal tiġieġ u dundjani sabiex tiġi żgurata s-sigurtà talkonsumatur, il-kura effikaċi fit-tiġieġ u d-dundjani, kif ukoll biex jitnaqqas ir-riskju ta' żvilupp ta' reżistenza antimikrobika għal enrofloxacin.
English: Therefore on 7 November 2013 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for all veterinary medicinal products containing enrofloxacin to be administered via drinking water to chickens and/or turkeys.
Maltese: Għalhekk, il-Kumitat adotta b'kunsens opinjoni pożittiva fis-7 ta' Novembru 2013, li tirrakkomanda varjazzjonijiet fit-termini talawtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali kollha li fihom enrofloxacin li għandu jingħata permezz tal-ilma tax-xorb lit-tiġieġ u/jew id-dundjani
English: Zeffix lamivudine
Maltese: Zeffix lamivudina
English: The full EPAR for Zeffix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Zeffix:
Maltese: Aktar informazzjoni dwar Zeffix:
English: Zeffix was as effective as alfa-interferon.
Maltese: Zeffix kien effettiv daqs alfa-interferon.
English: It is available as tablets (100 mg) and an oral solution (5 mg/ml).
Maltese: Jiġi bħala kapsuli (100 mg) u bħala soluzzjoni orali (5 mg/ml).
English: The active substance in Zeffix, lamivudine, is an antiviral agent that belongs to the class ‘nucleoside analogues'.
Maltese: Is-sustanza attiva f'Zeffix, il-lamivudina, hija sustanza antivirali tal-klassi tal-‘analogi nukleosidiċi'.
English: This document is a summary of the European public assessment report (EPAR) for Zeffix.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zeffix.
English: Zeffix is a medicine that contains the active substance lamivudine.
Maltese: Zeffix huwa mediċina li fiha s-sustanza attiva lamivudina.
English: Lamivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Maltese: Illamivudina tinterferixxi mal-azzjoni ta' enzima virali msejħa DNA polimerażi, li hija involuta filformazzjoni ta' DNA virali.
English: • compensated liver disease (when the liver is damaged but works normally), who also show signs that the virus is still multiplying and have signs of liver damage (raised levels of the liver enzyme alanine aminotransferase [ALT] and signs of damage when liver tissue is examined under a microscope).
Maltese: • mard tal-fwied ikkompensat (meta l-fwied ikollu ħsara iżda jibqa' jaħdem sew), li jkollhom ukoll sinjali li l-virus ikun għadu qed jimmultiplika, u li jkollhom sinjali ta' ħsara fil-fwied (żieda fil-livelli tal-enzima tal-fwied 'alanina aminotransferażi' [ALT - alanine aminotransferase] u sinjali ta' ħsara meta t-tessut tal-fwied jiġi analizzat taħt mikroskopju).
English: Zeffix is used to treat adults (aged 18 years or over) who have chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Maltese: Zeffix jintuża biex jiġu kkurati adulti (minn 18-il sena jew aktar) li għandhom epatite B kronika (fit-tul) (marda tal-fwied minħabba infezzjoni bil-virus tal-epatite B).
English: Why has Zeffix been approved?
Maltese: Għaliex ġie approvat Zeffix?
English: Zeffix has been studied in five main studies involving a total of 1,083 adults with compensated liver disease due to chronic hepatitis B. Three studies compared Zeffix with placebo (a dummy treatment), one of which looked particularly at ‘HBeAg-negative' patients.
Maltese: Zeffix ġie studjat f'ħames studji ewlenin li involvew total ta' 1,083 adult b'mard fil-fwied ikkumpensat minħabba l-epatite B kronika.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zeffix on 29 July 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zeffix fid-29 ta' Lulju 1999.
English: The recommended dose of Zeffix is 100 mg once a day.
Maltese: Id-doża rakkomandata ta' Zeffix hija ta' 100 mg kuljum.
English: What is the risk associated with Zeffix?
Maltese: X'inhu r-riskju assoċjat ma' Zeffix?
English: Doses lower than 100 mg need to be given using the oral solution.
Maltese: Dożi anqas minn 100 mg jeħtieġ li jingħataw bl-użu ta' soluzzjoni orali.
English: What is Zeffix?
Maltese: Għal xiex jintuża Zeffix?
English: The other two studies compared Zeffix taken on its own with alfa-interferon (another treatment used in chronic hepatitis B) on its own and with the combination of Zeffix and alfa-interferon.
Maltese: Iż-żewġ studji l-oħra qabblu Zeffix meħud waħdu ma' alfa-interferon (kura oħra użata fl-epatite B kronika) waħdu u flimkien ma' kombinazzjoni ta' Zeffix u alfo-interferon.
English: These are patients infected with hepatitis B virus that has mutated (changed), leading to a form of chronic hepatitis B that is more difficult to treat.
Maltese: Dawn huma pazjenti infettati bil-virus tal-epatite B b'mutazzjoni (inbidel), u wassal għal forma ta' epatite B kronika li hija iktar diffiċli sabiex tiġi kkurata.
English: In patients with decompensated liver disease, Zeffix also reduced levels of hepatitis B virus DNA and ALT.
Maltese: F'pazjenti b'mard tal-fwied dekompensat, Zeffix ukoll naqqas il-livelli tal-virus fid-DNA u l-ALT talepatite B.
English: How has Zeffix been studied?
Maltese: Kif ġie studjat Zeffix?
English: For the full list of all side effects or restrictions with Zeffix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha jew restrizzjonijiet irrapportati b'Zeffix, ara l-fuljett ta' tagħrif.