FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study, Xtandi was more effective than placebo at prolonging patients' lives: on average, patients treated with Xtandi lived for 18 months, compared with 14 months for patients given placebo.
Maltese: F'dan l-istudju, Xtandi kien aktar effettiv mill-plaċebo fit-titwil tal-ħajja tal-pazjenti: bħala medja, pazjenti li ngħataw kura bi Xtandi għexu għal 18-il xahar, meta mqabbla ma' 14-il xahar għall-pazjenti li ngħataw plaċebo.
English: Ref. EMEA/CHMP/173455/2009
Maltese: EMEA/CHMP/173447/2009
English: Dr. Antonio Addis (Italy)
Maltese: Antonio Addis (Italja)
English: Dr Catherine Moraiti (Greece)
Maltese: Dott. ssa Catherine Moraiti (Greċja)
English: London, 09 March 2009 Doc.
Maltese: Londra, 9 ta' Marzu 2009 Dok. ta' Ref.
English: What is Uman Big?
Maltese: X'inhu Uman Big?
English: Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection
Maltese: Human Hepatitis B Immunoglobulins, 180 IU/ml, soluzzjoni għal injezzjoni
English: Referral start date:
Maltese: Data ta' bidu tar-referenza:
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni saret skont referenza ‘tal-Artikolu 29'.
English: Uman Big is a solution of human hepatitis B immunoglobulins.
Maltese: Uman Big huwa soluzzjoni ta' immunolgobulini tal-epatite umana B.
English: Kedrion S.p.A. submitted Uman Big for mutual recognition on the basis of the initial authorisation granted by Italy on 2 June 1979.
Maltese: Kedrion S.p.A. issottomettiet Uman Big għar-rikonoxximent reċiproku abbażi tal-awtorizzazzjoni inizjali mogħtija mill-Italja fit-2 ta' Ġunju 1979.
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Uman Big 180 IU/ml, solution for injection.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' referenza wara nuqqas ta' ftehim fost Stati Membri tal-Unjoni Ewropea rigwar l-awtorizzazzjoni tal-mediċina Uman Big 180 IU/ml, soluzzjoni għal injezzjoni.
English: Hepatitis B immunoglobulins contain high levels of antibodies against the hepatitis B virus.
Maltese: L-immunolgobuli tal-epatite B fihom livelli għolja ta' antikorpi kontra l-vajrus tal-epatite B.
English: The European Commission issued a decision on 06 March 2009.
Maltese: Il-Kummissjoni Ewropea adottat deċiżjoni fis-6 ta' Marzu 2009.
English: On 31 October 2008, the Italian medicines agency, Agenzia Italiana del Farmaco, referred the matter to the CHMP.
Maltese: Fil-31 ta' Ottubru 2008, l-Aġenzija Taljana għall-Mediċini, l-Agenzia Italiana del Fármaco, irreferiet il-każ quddiem is-CHMP.
English: Questions and answers on the referral for Uman Big
Maltese: Mistoqsija u tweġiba dwar ir-referenza għal Uman Big
English: • in subjects who did not show an immune response after vaccination (and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
Maltese: • f'persuni li ma wrewx rispons immunitarju wara l-vaċċinazzjoni (u li għalihom hija meħtieġa prevenzjoni kontinwa minħabba r-riskju kontinwu li jiġu infettati bl-epatite B.
English: The company wanted the authorisation to be recognised in Austria, Denmark, Germany, Greece, Hungary, Poland, Portugal and Sweden (the concerned Member States).
Maltese: Il-kumpanija ried li l-awtorizzazzjoni tiġi rikonoxxuta fl-Awstrija, fid-Danimarka, fil-Ġermanja, fil-Greċja, fl-Ungerija, fil-Polonja, fil-Portugall u fl-Iżvezja (l-Istati Membri konċernati).
English: • in haemodialysed patients (patients whose kidneys have failed and who rely on a blood purification technique called haemodialysis), until vaccination has become effective;
Maltese: • f'pazjenti emodjalizzati (pazjenti li l-kliewi tagħhom waqfu jew li huma dipendenti fuq il purifikazzjoni teknika msejħa emodijaliżi), sakemm il-vaċċinazzjoni ssir effikaċi;
English: Immunoglobulins are blood proteins that have been extracted from donor plasma.
Maltese: L-immunolglobulini huma proteini tad-demm li ġew estratti mill-plażma ta' donatur.
English: Uman Big is given as an intramuscular (into the muscle) injection to prevent hepatitis B in the following cases:
Maltese: L-Uman Big jingħata bħala injezzjoni intramuskolari (fil-muskolu) għal prevenzjoni tal-epatite B fil-każijiet li ġejjin:
English: Why was Uman Big reviewed?
Maltese: Għaliex ġie rivedut l-Uman Big?
English: Based on evaluation of the currently available data and the scientific discussion within the Committee and at the CHMP's Blood Products Working Party, the CHMP concluded that the benefits of Uman Big outweigh its risks, and that therefore the marketing authorisation for Uman Big should be granted in all concerned member states.
Maltese: Il-Kumitat għall-prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) talAġenzija ikkonkluda illi l-benefiċċji tal-Uman Big huma ogħola mir-riskji tiegħu, u illi lawtorizzazzjoni għal fuq is-suq mogħtija fl-Italja tista' tiġi rikonoxxuta fl-Istati Membri l-oħra talUnjoni Ewropea u fiż-Żona Ekonomika Ewropea.
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Maltese: Eżitu ta' proċedura skont l-Artikolu 30 tad-Direttiva 2001/83/KE
English: EMA/CHMP/178705/2012 Rev. 1 EMEA/H/A-30/1283
Maltese: EMA/CHMP/178705/2012 Rev.
English: The company that markets the medicine is GlaxoSmithKline (GSK) Biologicals.
Maltese: Ilkumpanija li qiegħdet il-mediċina fis-suq hija GlaxoSmithKline (GSK) Biologicals.
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (warnings and precautions for use), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation) and 5.1 (pharmacodynamic properties).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħrajn tal-SmPC, inklużi s-sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.5 (interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni), 4.6 (fertilità, tqala u treddigħ) u 5.1 (tagħrif farmakodinamiku).
English: On 15 March 2012, the European Medicines Agency completed a review of Priorix.
Maltese: Fil-15 ta' Marzu 2012, l-Aġenzija Ewropea għall-Mediċini temmet analiżi ta' Priorix.
English: What is Priorix?
Maltese: X'inhu Priorix?
English: There was some inconsistency between EU countries regarding the approved lower age limit for Priorix, which varied from nine months to 15 months of age.
Maltese: Kien hemm ċerta inkonsistenza bejn il-pajjiżi tal-UE rigward l-età minima approvata għal Priorix, li varjat bejn l-etajiet ta' disa xhur sa 15-il xahar.
English: The CHMP decided to contraindicate the use of Priorix in people with symptomatic, advanced HIV, since these patients have a severely weakened immune system which puts them at risk of serious health problems following vaccination with attenuated measles virus.
Maltese: Is-CHMP iddeċieda li jagħti kontra-indikazzjoni għall-użu ta' Priorix f'nies b'HIV sintomatiku u avvanzat minħabba li dawn il-pazjenti għandhom sistema immuni severament dgħajfa li tqiegħdhom f'riskju ta' problemi serji tas-saħħa wara t-tilqima bil-virus attenwat tal-ħosba.
English: Due to the divergent national positions, on 20 May 2011, GlaxoSmithKline Biologicals referred the matter to the CHMP in order to harmonise the marketing authorisations for Priorix in the EU.
Maltese: Minħabba l-pożizzjonijiet nazzjonali diverġenti, fl-20 ta' Mejju 2011, GlaxoSmithKline Biologicals irriferiet il-kwistjoni lis-CHMP sabiex jarmonizza l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Priorix fl-UE.
English: There was some inconsistency between EU countries regarding the use of Priorix in patients infected with HIV.
Maltese: Kien hemm ċerta inkonsistenza bejn il-pajjiżi tal-UE rigward l-użu ta' Priorix f'pazjenti infettati bl-HIV.
English: Priorix is a vaccine used to protect against measles, mumps and rubella (German measles).
Maltese: Priorix huwa vaċċin użat biex jipproteġi kontra l-ħosba, il-gattone u r-rubella (il-ħosba Ġermaniża).
English: The CHMP recommended that this should be harmonised to nine months of age.
Maltese: Is-CHMP irrakkomanda li din għandha tiġi armonizzata għall-età ta' disa' xhur.
English: It can be used in adults, adolescents and children from nine months of age.
Maltese: Jista' jintuża f'adulti, adoloxxenti u tfal ikbar minn disa' xhur.
English: The CHMP recommended arranging this section according to the dosing recommendations for different age groups.
Maltese: Is-CHMP irrakkomanda li din is-sezzjoni tiġi rranġata skont ir-rakkomandazzjonijiet ta' dożaġġ għallgruppi ta' etajiet differenti.
English: Priorix contains small amounts of attenuated (weakened) forms of the viruses that cause measles, mumps and rubella.
Maltese: Priorix fih ammonti żgħar ta' forom attenwati (imdgħajfa) tal-virusijiet li jikkaġunaw il-ħosba, ilgattone u r-rubella.
English: Priorix is authorised in the EU via national procedures.
Maltese: Priorix huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Priorix is marketed in all EU Member States as well as in Norway and Iceland.
Maltese: Priorix huwa mqiegħed fis-suq tal-Istati Membri kollha tal-UE kif ukoll fin-Norveġja u l-Islanda.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Fid-dawl tad-dejta sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP kien tal-fehma li lSmPCs, it-tikkettar u l-fuljett ta' tagħrif għandhom jiġu armonizzati madwar l-UE.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Dan wassal għal diverġenzi bejn l-Istati Membri fil-mod kif tista' tintuża l-mediċina, kif jidher fid-differenzi fis-sommarji tal-karatterisiċi talprodott (SmPCs), fit-tikkettar u l-fuljetti ta' tagħrif fil-pajjiżi fejn il-mediċina tqiegħdet fis-suq.
English: 1 17p deletion or TP53 mutation, see http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp
Maltese: 1 It-tħassir ta' 17p jew il-mutazzjoni TP53, ara http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016 EMA/488322/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The percentage of deaths in the treatment arms was 8% in the CLL study and 8% and 5% in the lymphoma studies, compared with 3%, 6% and 1% respectively in the placebo arms.
Maltese: Il-perċentwal ta' mwiet fil-fergħat ta' kura kien 8 % fl-istudju CLL u 8 % u 5 % fl-istudji tal-linfoma, imqabbla ma' 3 %, 6 % u 1 % rispettivament fil-fergħat talplaċebo.
English: Patients should be monitored for respiratory signs and symptoms.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi respiratorji.
English: Zydelig is a cancer medicine containing the active substance idelalisib.
Maltese: Zydelig huwa mediċina ta' kontra l-kanċer li fiha s-sustanza attiva idelalisib.
English: • There have been reports of serious infections in clinical studies with the cancer medicine Zydelig.
Maltese: • Kien hemm rapporti ta' infezzjonijiet serji fi studji kliniċi bil-mediċina kontra l-kanċer Zydelig.
English: The review of Zydelig was initiated at the request of the European Commission on 17 March 2016, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Zydelig inbdiet fuq talba tal-Kummissjoni Ewropea fis-17 ta' Marzu 2016, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: The additional deaths were mainly caused by infections, including Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Maltese: L-imwiet addizzjonali kienu primarjament ikkawżati minn infezzjonijiet, inkluż pulmonite tat-tip Pneumocystis jirovecii u infezzjonijiet b'ċitomegalovirus.
English: In the EU, Zydelig is authorised for the treatment of two cancers of white blood cells, chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin's lymphomas).
Maltese: Fl-UE, Zydelig huwa atorizzat għall-kura ta' żewġ kanċers taċ-ċelluli bojod tad-demm, lewkimja limfoċitika kronika u linfoma follikulari (wieħed minn grupp ta' kanċers imsejħa linfomi mhux ta' Hodgkin).
English: • If you are taking Zydelig, you will receive antibiotics to prevent a type of lung infection (Pneumocystis jirovecii pneumonia).
Maltese: • Jekk qed tieħu Zydelig, ser tirċievi antibijotiċi biex jimpedixxu tip ta' infezzjoni tal-pulmun (Pneumocystis jirovecii pneumonia).
English: The CHMP (EMA's Committee for Medicinal Products for Human Use) has confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects.
Maltese: Fil-21 ta' Lulju 2016, is-CHMP (il-Kumitat tal-EMA għall-Prodotti Mediċinali għall-Użu mill-Bniedem) ikkonferma li l-benefiċċji ta' Zydelig (idelalisib) fil-kura tal-kanċers tad-demm imsejħa lewkimja limfoċitika kronika (CLL) u linfoma follikulari huma akbar mir-riskju ta' effetti sekondarji.
English: • Increased rates of serious adverse effects including deaths were seen in the treatment arm of 3 clinical trials2 evaluating the addition of Zydelig to standard therapy in first-line treatment of CLL and relapsed indolent non-Hodgkin lymphoma.
Maltese: • Rati miżjuda ta' effetti avversi serji inkluż imwiet dehru fil-fergħa ta' kura ta' 3 provi kliniċi2 li tevalwa ż-żieda ta' Zydelig ma' terapija standard fl-ewwel linja tal-kura ta' CLL u linfoma mhux ta' Hodgkin indolenti rikaduta.
English: • In chronic lymphocytic leukaemia, Zydelig is used in combination with another medicine (rituximab) in patients who have received at least one previous treatment and in previously untreated patients who have genetic mutations in their cancer cells called 17p deletion or TP53 mutation and who are not eligible for other therapies.
Maltese: • F'lewkimja limfoċitika kronika, Zydelig jintuża flimkien ma' mediċina oħra (rituximab) f'pazjenti li rċevew mill-inqas kura waħda preċedenti u f'pazjenti mhux ikkurati preċedentament li għandhom mutazzjonijiet ġenetiċi fiċ-ċelluli tal-kanċer tagħhom imsejħa tħassir ta' 17p jew mutazzjoni TP53 u li mhumiex eliġibbli għal terapiji oħrajn.
English: GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL;
Maltese: GS-US-313-0125 studju tal-fażi 3, randomizzat, double blind, ikkontrollat bi plaċebo li jevalwa l-effikaċja u s-sigurtà ta' idelalisib flimkien ma' bendamustine u rituximab għal iNHL ikkurata qabel;
English: GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL;
Maltese: GS-US-313-0124 studju tal-fażi 3, randomizzat, double blind, ikkontrollat bil-plaċebo li jevalwa l-effikaċja u s-sigurtà ta' idelalisib flimkien ma' rituximab għal iNHL ikkurata qabel;
English: 2 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL;
Maltese: GS-US-312-0123, studju tal-fażi 3, randomizzat, double blind, ikkontrollat bi plaċebo li jevalwa l-effikaċja u s-sigurtà ta' idelalisib flimkien ma' bendamustine u rituximab għal CLL li qabel ma kinitx ikkurata;
English: • Your doctor will regularly check you for signs of infections.
Maltese: • It-tabib tiegħek se jiċċekkjak b'mod regolari għal sinjali ta' infezzjonijiet.
English: CHMP confirms recommendations for use of Zydelig
Maltese: Aktar informazzjoni dwar l-użu approvat ta' Zydelig tista' tinstab hawn
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and for 2 to 6 months after stopping treatment.
Maltese: • Il-pazjenti kollha għandhom jirċievu profilassi għal pulmonite tat-tip P. jirovecii matul kura b'Zydelig u 2 sa 6 xhur wara li jwaqqfu l-kura.
English: All patients treated with Zydelig should be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia during treatment and this should be continued for up to 6 months after treatment with Zydelig has stopped.
Maltese: Il-pazjenti kollha kkurati b'Zydelig għandhom jingħataw medikazzjoni preventiva kontra l-infezzjoni filpulmun, pulmunite tat-tip Pneumocystis jirovecii waqt il-kura u din għandha titkompla sa 6 xhur wara li l-kura b'Zydelig tkun twaqqfet.
English: • Zydelig may also be used in combination with rituximab, as first line treatment in CLL in the presence of 17p deletion or TP53 mutation provided patients cannot take any alternative treatment and provided again that the below measures are followed to reduce the risk of infection.
Maltese: • Zydelig jista' wkoll jintuża flimkien ma' rituximab, bħala kura fl-ewwel linja f'CLL fil-preżenza tattħassir ta' 17p jew il-mutazzjoni TP53 diment li l-pazjenti ma jkunu jistgħu jieħdu l-ebda kura alternattiva u għal darb'oħra diment li l-miżuri t'hawn taħt jiġu segwiti biex jitnaqqas ir-riskju ta' infezzjoni.
English: • Provided that strengthened measures are followed to minimise the risk of infection (see below), Zydelig can continue to be used in combination with rituximab in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
Maltese: • Diment li l-miżuri msaħħa jiġu segwiti biex jitnaqqas ir-riskju ta' infezzjoni (ara hawn taħt), Zydelig jista' jibqa' jintuża f'kombinazzjoni ma' rituximab biss, f'pazjenti b'CLL li jkunu rċevew għall-inqas terapija preċedenti waħda, u bħala monoterapija f'pazjenti b'linfoma follikulari li hija refrattarja għal żewġ linji ta' kura.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended and specific guidance is included in the updated summary of product characteristics (SmPC).
Maltese: Huwa rakkomandat ukoll monitoraġġ regolari kliniku u tal-laboratorju għallinfezzjoni b'ċitomegalovirus u hija inkluża gwida speċifika fis-sommarju tal-karatteristiċi tal-prodott (SmPC) aġġornat.
English: player
Maltese: MEMBRI
English: Some detail about cleaning the Turbospin device.
Maltese: Spjegazzjoni tat-Turbospin u kif jaħdem.
English: Explain that the device should be discarded after 28 days.
Maltese: Jispjegaw li t-tagħmir għandu jintrema wara 28 jum.
English: DVD player
Maltese: MILLISTATI
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member States shall agree the final healthcare professional and patient educational pack with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Maltese: L-Istati Membri għandhom jaqblu dwar il-materjal edukattiv finali għall-pazjent u għal professjonista fil-qasam tal-kura tas-saħħa mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) qabel ittnedija tal-prodott fit-territorju tagħhom.
English: • Introduction to the product: provide information on the contents of the box ie that 28 days treatment is 56 capsules and 1 device.
Maltese: kura huma ekwivalenti għal 56 kapsula u tagħmir wieħed.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD L-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: The Physician and patient “DVDs/leaflet forms” should contain the following key elements and messages:
Maltese: Id-“DVDs/forom ta' fuljett” għat-tabib u għall-pazjent għandu jkun fihom l-elementi u l-messaġġi ewlenin li ġejjin:
English: The Member States shall ensure that all physicians who are expected to prescribe or use Colobreathe are provided with a healthcare professional and patient educational pack containing the following:
Maltese: L-Istati Membri għandhom jiżguraw li l-kundizzjonijiet jew restrizzjonijiet kollha fir-rigward tal-użu mingħajr periklu u effettiv tal-prodott mediċinali deskritti hawn taħt, ikunu implimentati:
English: • The Summary of Product Characteristics
Maltese: • Is-Sommarju tal-Karatteristiċi tal-Prodott
English: • “Physician DVD” information in “leaflet form” for those physicians who do not have access to a
Maltese: • L-informazzjoni tad-“DVD tal-Pazjent” f'“forma ta' fuljett” għal dawk il-pazjenti li m'għandhomx
English: The full EPAR for Lamivudine Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Lamivudine Teva Pharma B.V jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Lamivudine Teva Pharma B.V., lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Maltese: Is-sustanza attiva f'Lamivudine Teva Pharma B.V., il-lamivudina, hija inibitur nukleosidiku tattranskrittażi inversa (nucleoside reverse transcriptase inhibitor - NRTI).
English: The recommended dose of Lamivudine Teva Pharma B.V. for adults and children weighing at least 25 kg is 300 mg a day.
Maltese: Id-doża rakkomandata ta' Lamivudine Teva Pharma B.V. għal adulti u tfal li jiżnu mill-inqas 25 kg hija 300 mg kuljum.
English: Lamivudine Teva Pharma B.V. is an antiviral medicine containing the active substance lamivudine.
Maltese: Lamivudine Teva Pharma B.V. huwa mediċina antivirali li fiha s-sustanza attiva lamivudina.
English: The European Commission granted a marketing authorisation valid throughout the EU for Lamivudine Teva Pharma B.V. on 10 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-UE kollha għal Lamivudine Teva Pharma B.V. fl-10 ta' Diċembru 2009.
English: Lamivudine Teva Pharma B.V. is a ‘generic medicine'.
Maltese: Lamivudine Teva Pharma B.V. huwa ‘mediċina ġenerika'.
English: Lamivudine Teva Pharma B.V. is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Lamivudine Teva Pharma B.V. jintuża flimkien ma' mediċini antivirali oħra biex jikkura adulti u tfal infettati bil-virus tal-immunodefiċjenza umana (HIV), il-virus li jikkawża s-sindromu tad-defiċenza immunitarja (l-AIDS).
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku lamivudina
English: This is a summary of the European public assessment report (EPAR) for Lamivudine Teva Pharma B.V.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lamivudine Teva Pharma B.V.
English: Because Lamivudine Teva Pharma B.V. is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Epivir.
Maltese: Billi Lamivudine Teva Pharma B.V. huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw li hu bijoekwivalenti għall-mediċina ta' referenza, Epivir.
English: Other information about Lamivudine Teva Pharma B.V.
Maltese: Informazzjoni oħra dwar Lamivudine Teva Pharma B.V.
English: This means that Lamivudine Teva Pharma B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Epivir.
Maltese: Dan ifisser li Lamivudine Teva Pharma B.V. huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Epivir.
English: The CHMP concluded that, in accordance with EU requirements, Lamivudine Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Epivir.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Lamivudine Teva Pharma B.V. intwera li għandu kwalità komparabbli u huwa bijoekwlvalenti għal Epivir.
English: Lamivudine Teva Pharma B.V.
Maltese: X'inhu Lamivudine Teva Pharma B.V.?