FrancophonIA/ELRC3.0 huggingface dataset:
English: Ribavirin BioPartners is a medicine that contains the active substance ribavirin.
Maltese: Ribavirin BioPartners hija mediċina li fiha s-sustanza attiva ribavirin.
English: This means that Ribavirin BioPartners is similar to a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Maltese: Dan ifisser li Ribavirin BioPartners huwa simili għall'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Rebetol.
English: What are the benefit and risk of Ribavirin BioPartners?
Maltese: X'inhuma l-benefiċċju u r-riskju ta' Ribavirin BioPartners?
English: The CHMP concluded that, in accordance with EU requirements, Ribavirin BioPartners has been shown to have comparable quality and to be bioequivalent to Rebetol.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Ribavirin BioPartners intwera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Rebetol.
English: Other information about Ribavirin BioPartners:
Maltese: Tagħrif ieħor dwar Ribavirin BioPartners:
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsija u tweġiba hawnhekk.
English: How is Ribavirin BioPartners used?
Maltese: Kif jintuża Ribavirin BioPartners?
English: Ribavirin BioPartners is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Maltese: Ribavirin BioPartners jintuża għat-trattament ta' epatite Ċ kronika (marda tal-fwied dovuta għal infezzjoni bil-virus tal-epatite C) f'pazjenti li għandhom minn tliet snin ‘l fuq.
English: Treatment with Ribavirin BioPartners should be started and monitored by a doctor who has experience in the management of long-term hepatitis C. The dose of Ribavirin BioPartners is based on the patient's body weight, and ranges from three to seven tablets a day.
Maltese: Trattament b'Ribavirin BioPartners għandu jinbeda u jiġi mmonitorjat minn tabib li jkollu esperjenza filġestjoni ta' epatite Ċ għal perjodu ta' żmien twil.
English: How has Ribavirin BioPartners been studied?
Maltese: Kif ġie studjat Ribavirin BioPartners?
English: Why has Ribavirin BioPartners been approved?
Maltese: Għaliex ġie approvat Ribavirin BioPartners?
English: Ribavirin BioPartners is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Maltese: Ribavirin BioPartners huwa maħsub li jinterferixxi mal-produzzjoni jew mal-azzjoni ta' DNA u RNA virali, li huma meħtieġa sabiex il-virusijiet jissopravvivu u jimmultiplikaw.
English: Because Ribavirin BioPartners is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Maltese: Minħabba li Ribavirin BioPartners hija mediċina ġenerika u hija bioekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tagħha huma kkunsidrati li huma l-istess bħal tal-mediċina ta'
English: For more information about treatment with Ribavirin BioPartners, read the Package Leaflet (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar trattament b'Ribavirin BioPartners, aqra l-Fuljett ta' Tagħrif (parti wkoll tal-EPAR).
English: The full EPAR for Ipreziv 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: It is available as tablets (20 mg, 40 and 80 mg).
Maltese: Jiġi f'pilloli (20 mg, 40 mg u 80 mg).
English: EPAR summary for the public azilsartan medoxomil
Maltese: Sommarju tal-EPAR għall-pubbliku azilsartan medoxomil
English: What is Ipreziv?
Maltese: Ipreziv?
English: Why has Ipreziv been approved?
Maltese: Għaliex ġie approvat Ipreziv?
English: Ipreziv 40 and 80 mg was also more effective than ramipril (10 mg).
Maltese: Ipreziv 40 u 80 mg kien ukoll aktar effettiv mir-ramipril (10 mg).
English: In the two studies with Ipreziv taken alone compared with placebo, patients had an average fall in systolic blood pressure of about 13.5 mmHg on Ipreziv 40 mg and a fall of about 14.5 mmHg on Ipreziv 80 mg after 6 weeks.
Maltese: Fiż-żewġ studji fuq Ipreziv meħud waħdu apparagun ma' plaċebo, il-pazjenti kellhom tnaqqis medju fil-pressjoni sistolika tad-demm ta' madwar 13.5 mmHg b'Ipreziv 40 mg u tnaqqis ta' madwar 14.5 mmHg b'Ipreziv 80 mg wara 6 ġimgħat.
English: What is the risk associated with Ipreziv?
Maltese: X'inhu r-riskju assoċjat ma' Ipreziv?
English: Three studies investigated the effects of Ipreziv in combination with other antihypertensive medicines (chlortalidone, amlodipine, and hydrochlorothiazide).
Maltese: Tliet studji investigaw l-effetti ta' Ipreziv meħud ma' mediċini anti-ipertensivi oħra (klortalidonu, amlodipina, u idroklorotijażid).
English: Ipreziv on its own was more effective than placebo.
Maltese: Ipreziv waħdu kien aktar effettiv minn plaċebo.
English: The CHMP concluded that Ipreziv belongs to an established class of medicines in the treatment of hypertension and its risks are similar to others within this class.
Maltese: Is-CHMP ikkonkluda li Ipreziv jagħmel parti minn klassi stabbilita ta' mediċini fil-kura tal-ipertensjoni u li r-riskji tiegħu huma simili għal mediċini oħrajn ta' din il-klassi.
English: When Ipreziv alone was compared with other medicines, 80 mg of Ipreziv was more effective in lowering blood pressure than the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg).
Maltese: Meta Ipreziv waħdu tqabbel ma' mediċini oħra, 80 mg ta' Ipreziv kien aktar effettiv fit-tnaqqis talpressjoni tad-demm milli l-ogħla doża approvata tal-valsartan (320 mg) u tal-olmesartan medoxomil (40 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ipreziv on 07 December 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ipreziv fil- 7 ta' Diċembru 2011.
English: How has Ipreziv been studied?
Maltese: Kif ġie studjat Ipreziv?
English: Ipreziv is a medicine that contains the active substance azilsartan medoxomil.
Maltese: Ipreziv huwa mediċina li fih s-sustanza attiva azilsartan medoxomil.
English: Other information about Ipreziv
Maltese: Kif jintuża
English: This is a summary of the European public assessment report (EPAR) for Ipreziv.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ipreviz.
English: The active substance in Ipreziv, azilsartan medoxomil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Ipreziv, l-azilsartan medoxomil hija ‘antagonista tar-riċettur tal-anġjotensina
English: Side effects with Ipreziv are generally mild or moderate, with the most common side effect being dizziness.
Maltese: L-effetti sekondarji b'Ipreziv huma ġeneralment ħfief jew moderati, u l-aktar effett sekondarju komuni huwa l-isturdament.
English: Five studies investigated the effects of Ipreziv taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil).
Maltese: Ħames studji investigaw l-effetti ta' Ipreziv meħud waħdu, u qabbluh ma' plaċebo (kura finta) jew ma' mediċini anti-ipertensivi oħra (ramipril, valsartan u olmesartan medoxomil).
English: The effects of Ipreziv were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Ipreziv għall-ewwel ġew ittestjati f'mudeli sperimentali qabel ma ġew studjati fil-bnedmin.
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 80 mg, or another medicine for hypertension, such as chlortalidone or hydrochlorothiazide, can be added.
Maltese: Jekk ilpressjoni tad-demm ma tkunx ikkontrollata biżżejjed, id-doża tista' tiżdied għal 80 mg, jew tista' tiżdied mediċina oħra kontra l-ipertensjoni, bħall-klortalidonu jew l-idroklorotijażid.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ipreziv.
Maltese: L-istudji wrew ukoll li Ipreziv, meta jittieħed flimkien ma' mediċini oħra, jista' jipproduċi tnaqqis addizzjonali fil-pressjoni tad-demm apparagun ma' meta dawn il-mediċini jittieħdu mingħajr Ipreziv.
English: Ipreziv is taken by mouth and the usual recommended dose is 40 mg once a day.
Maltese: Ipreziv jittieħed mill-ħalq u d-doża normalment irrakkomandata hija 40 mg darba kuljum.
English: Efficacy of bendamustine in multiple myeloma (MM)
Maltese: Effikaċja ta' bendamustine f'majeloma multipla (multiple myeloma - MM)
English: Luxembourg Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München
Maltese: Il-Lussemburgu Astellas Pharma GmbH Georg-Brauchle-Ring 64-66
English: Belgium Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München
Maltese: Id-Danimarka Astellas Pharma GmbH Georg-Brauchle-Ring 64-66
English: The trial included 549 patients and the ORR was similar between the two groups (93.8% vs. 93.5%).
Maltese: Il-prova kienet tinkludi 549 pazjent u l-ORR kienet simili bejn iż-żewġ gruppi (93.8% vs.
English: Efficacy in rituximab-refractory NHL is supported by 75% overall response rates (ORR), 58% partial response and 14% complete response (CR) with a median duration of response of 40.14 weeks.
Maltese: L-effikaċja fl-NHL refrattarja għal rituximab hija appoġġata minn rati ta' reazzjoni globali (overall response rates - ORR) ta' 75%, reazzjoni parzjali ta' 58% u reazzjoni totali (complete response - CR) ta' 14% b'tul ta' żmien medjan ta' reazzjoni ta' 40.14 ġimgħa.
English: Patients in the BP group demonstrated a longer TTF (14 vs. 9 months) and a higher percentage of complete remission (32% vs. 11%).
Maltese: Ilpazjenti fil-grupp BP urew TTF itwal (14 vs. 9 xhur) u perċentwal aktar għoli ta' remissjoni totali (32% vs. 11%).
English: The Applicant presented an abstract of the final analysis of a trial in first line setting, comparing bendamustine in combination with rituximab (B-R) to R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin (Adriamycin), Oncovin (vincristine), and prednisone) treatment, allowing the contribution of bendamustine vs CHOP to be deduced.
Maltese: L-Applikant ippreżenta sommarju tal-analiżi finali ta' prova f'sitwazzjoni tal-bidu, li tqabbel bendamustine flimkien ma' rituximab (B-R) ma' trattament R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin (Adriamycin), Oncovin (vincristine), u prednisone), filwaqt li ppermetta t-tnaqqis tal-kontribuzzjoni ta' bendamustine vs CHOP.
English: An application for a decentralised procedure was submitted in November 2007 for the following three indications: first-line treatment of chronic lymphocytic leukaemia (CLL), first-line treatment of advanced indolent non-Hodgkin´s lymphomas (NHL) in rituximab-refractory patients and advanced multiple myeloma (MM).
Maltese: F'Novembru 2007, ġiet sottomessa applikazzjoni għal proċedura deċentralizzata għat-tliet indikazzjonijiet li ġejjin: trattament tal-bidu għal lewċemija limfoċitika kronika (chronic lymphocytic leukaemia - CLL), trattament tal-bidu ta' limfomi indolenti mhux ta' Hodgkin avvanzati (non-Hodgkin´s lymphomas - NHL) f'pazjenti refrattarji għal rituximab u majeloma multipla avvanzata (advanced multiple myeloma - MM).
English: In the opinion of the CHMP, the proposed restricted indication clearly describes a fairly small patient population who cannot profit from the superior recently introduced regimens MPT (melphalan, prednisone and thalidomide) or MTV (melphalan, topotecan and VP-16 phosphate), including thalidomide or bortezomib.
Maltese: Fl-opinjoni tas-CHMP, lindikazzjoni ristretta proposta tiddeskrivi b'mod ċar popolazzjoni ta' pazjenti pjuttost żgħira li ma jistgħux jibbenefikaw mill-pjanijiet ta' terapiji superjuri li ġew introdotti b'mod reċenti ta' MPT (melphalan, prednisone u thalidomide) jew MTV (melphalan, topotecan u VP-16 phosphate), inklużi thalidomide jew bortezomib.
English: Efficacy of bendamustine in rituximab-refractory non-Hodgkin´s lymphoma (NHL)
Maltese: L-effikaċja ta' bendamustine fil-limfoma mhux ta' Hodgkin (NHL) refrattarja għal rituximab
English: According to the CHMP anticancer guideline (CPMP/EWP/205/95/Rev.3/Corr.
Maltese: Skont il-linji gwida kontra l-kanċer tas-CHMP (CPMP/EWP/205/95/Rev.3/Corr.), TTF bħala punt ta' tmiem primarju ma jippermettix li tiġi vvalutata l-effikaċja.
English: The prospectively planned subgroup analysis in patients over 60 years showed an advantage of BP over MP in terms of TTF (14 vs. 9 months) and also in terms of PFS (18 vs. 11 months).
Maltese: L-analiżi tas-subgrupp ippjanata prospettivament f'pazjenti ta' aktar minn 60 sena wriet vantaġġ tal-BP fuq l-MP f'termini ta' TTF (14 vs. 9 xhur) u wkoll f'termini ta' PFS (18 vs. 11-il xahar).
English: The Applicant provided data from a prospective, multi-centre randomised controlled pivotal trial comparing the efficacy of first-line chemotherapy with bendamustine and prednisone (BP) to melphalan and prednisone therapy (MP) in patients with previously untreated multiple myeloma.
Maltese: L-Applikant ipprovda dejta minn prova pivotali kkontrollata, randomizzata, b'aktar minn ċentru wieħed prospettiva li tqabbel l-effikaċja ta' kimoterapija tal-bidu b'bendamustine u prednisone (BP) ma' terapija b'melphalan u prednisone (MP) f'pazjenti b'majeloma multipla li ma ġietx ikkurata qabel.
English: Durable responses may be linked to patient benefit by clinically relevant reduction of disease burden (greater than 50% decrease of measurable disease in 78% of patients).
Maltese: Reazzjonijiet li jdumu jistgħu jiġu marbuta malbenefiċċju tal-pazjent permezz ta' tnaqqis tal-piż tal-marda klinikament rilevanti (tnaqqis ta' aktar minn 50% ta' marda li tista' titkejjel f'78% tal-pazjenti).
English: The CHMP noted the submitted trials assessing the role of bendamustine in CLL, MM and rituximabrefractory NHL.
Maltese: Is-CHMP innota l-provi sottomessi li jivvalutaw l-irwol ta' bendamustine f'CLL, MM u NHL refrattarja għal rituximab.
English: The CR rate was significantly higher for the B-R group (40.1 vs. 30.8%), PFS was higher (54.8 vs. 34.8 months) and the Hazard Ratio (HR) was 0.5765.
Maltese: 34.8 xhur) u l-Proporzjon ta' Riskju (Hazard Ratio - HR) kien ta' 0.5765.
English: Results in subgroups of patients older than 60 or 65 years are consistent and in clinical practice, bendamustine in combination with prednisone is currently recommended to patients over 80 years by the German Oncology Society.
Maltese: Ir-riżultati f'subgruppi ta' pazjenti ta' aktar minn 60 jew 65 sena huma konsistenti u filprattika klinika, bendamustine flimkien ma' prednisone huwa attwalment rakkomandat għal pazjenti ta' aktar minn 80 sena mis-Soċjetà tal-Onkoloġija Ġermaniża.
English: Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.”
Maltese: Trattament tal-bidu għal majeloma multipla (Stadju Durie-Salmon II bi progress jew stadju III) flimkien ma' prednisone għal pazjenti ta' aktar minn 65 sena li mhumiex eliġibbli għal trapjant awtologu taċ-ċelloli ewlenin u li għandhom newropatija klinika fiż-żmien tad-dijanjożi li tipprekludi lużu ta' trattament li fih thalidomide jew bortezomib.”
English: The Applicant therefore provided a retrospective calculation of progression free survival (PFS) which demonstrated an advantage for the BP arm (15 vs. 12 months) but of borderline statistical significance.
Maltese: L-Applikant għalhekk ipprovda kalkolu retrospettiv ta' sopravivenza mingħajr progressjoni (progression free survival - PFS) li wera vantaġġ għall-grupp BP (15 vs. 12-il xahar) iżda ta' sinifikanza statistika marġinali.
English: Bendamustine has been used clinically as an antineoplastic agent in the German Democratic Republic since 1971 and there is therefore substantial clinical experience with bendamustine in Germany.
Maltese: Bendamustine ilu jintuża b'mod kliniku bħala aġent antineoplastiku fir-Repubblika Demokratika Ġermaniża mill-1971 u għalhekk hemm esperjenza klinika sostanzjali b'bendamustine fil-Ġermanja.
English: Subgroup analyses of ORR, disease rate and PFS results demonstrate overall homogeneous results.
Maltese: Analiżi tas-subgrupp ta' ORR, ir-rata tal-marda u r-riżultati tal-PFS juru riżultati globali omoġeni.
English: The Applicant presented consistent similar results for patients >65 years and also provided case reports of heavily pre-treated and otherwise refractory MM patients who could be rescued with bendamustine combination therapy.
Maltese: L-Applikant ippreżenta riżultati simili konsistenti għal pazjenti >65 sena u pprovda wkoll rapporti tal-każijiet ta' pazjenti b'MM pre-trattati ħafna u inkella refrattarji li setgħu jiġu salvati b'terapija ta' kombinazzjoni b'bendamustine.
English: In conclusion, the CHMP adopted the following indications:
Maltese: Bħala konklużjoni, is-CHMP adotta l-indikazzjonijiet li ġejjin:
English: Furthermore, the Applicant proposed to perform a comparative post-approval trial in the rituximabrefractory setting (bendamustine compared to investigator's best choice).
Maltese: Barra minn hekk, l-Applikant ippropona li jwettaq prova komparattiva ta' wara l-approvazzjoni fis-sitwazzjoni refrattarja għal rituximab (bendamustine mqabbel mal-aħjar għażla tal-investigatur).
English: Finally, the Applicant discussed the hurdles associated with performing a randomised study suitable to support the current application as well as the selection of an appropriate primary endpoint, raising the issues of the impact of the limitations of the only currently available treatment option for patients refractory to rituximab therapy (britumomab tiuxetan) on the recruitment of patients and the ethical concerns of a comparison against the investigators best.
Maltese: Fl-aħħar nett, l-Applikant iddiskuta l-problemi assoċjati mat-twettiq ta' studju randomizzat adattat biex jappoġġa l-applikazzjoni attwali kif ukoll l-għażla ta' punt ta' tmiem primarju xieraq, u qajjem il-kwistjonijiet tal-impatt tallimitazzjonijiet tal-għażla ta' trattament unika disponibbli bħalissa għal pazjenti refrattarji għatterapija b'rituximab (britumomab tiuxetan) fuq ir-reklutaġġ ta' pazjenti u t-tħassib etiku ta' tqabbil mal-aħjar għażla tal-investigatur.
English: Even though the duration of remission was longer in the BP arm (18 vs. 12 months), overall survival was similar (35 vs. 33 months).
Maltese: Anke jekk it-tul ta' żmien għar-remissjoni kien itwal fil-grupp BP (18 vs. 12-il xahar), issopravivenza globali kienet simili (35 vs. 33 xahar).
English: The CHMP considered that the long clinical experience, the well established safety profile with manageable toxicities and the promising results presented in the submitted trials support the use of bendamustine in a population in need of further treatment options.
Maltese: Madankollu, dan in-nuqqas ta' dejta tal-effikaċja konformi mal-ICH huwa kkumpensat minn profil ta' sigurtà stabbilit sew b'tossiċitajiet mistennija u maniġġevoli.
English: The CHMP agreed that the BP regimen had documented efficacy in multiple myeloma as shown by the longer median PFS and TTF compared to the MP arm.
Maltese: Is-CHMP qabel li l-pjan ta' terapija BP kellu effikaċja ddokumentata fil-majeloma multipla kif muri mill-PFS u TTF b'medjan itwal meta mqabbel malgrupp MP.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATIONS
Maltese: ANNESS IV KUNDIZZJONIJIET TAL-AWTORIZZAZZJOIJIET GĦAT-TQEGĦID FIS-SUQ
English: - the lack of ICH-compliant efficacy data is compensated by a well established safety profile with expected and manageable toxicities which are correctly reflected in the proposed Product Information,
Maltese: - in-nuqqas ta' dejta tal-effikaċja konformi mal-ICH huwa kkumpensat minn profil ta' sigurtà stabbilit sew b'tossiċitajiet mistennija u maniġġevoli li huma riflessi b'mod tajjeb fl-Informazzjoni dwar ilProdott proposta,
English: Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.
Maltese: Limfomi indolenti mhux ta' Hodgkin bħala monoterapija f'pazjenti, li kellhom progress matul jew sa 6 xhur wara trattament b'rituximab jew pjan ta' terapija li fih rituximab.
English: The primary endpoints were time to treatment failure (TTF) and the secondary endpoints were survival time, survival rate after 2 years, rate and duration of remission, toxicity, quality of life and crossresistance.
Maltese: Il-punti ta' tmiem primarji kienu ż-żmien għall-falliment tat-trattament (time to treatment failureTTF) u l-punti ta' tmiem sekondarji kienu ż-żmien tas-sopravivenza, ir-rata ta' sopravivenza wara sentejn, ir-rata u t-tul ta' żmien tar-remissjoni, it-tossiċità, il-kwalità tal-ħajja u l-kross-reżistenza.
English: Only the overall response rate (ORR) and the complete remission rates were superior in the BP arm.
Maltese: Ir-rata ta' reazzjoni globali (overall response rate - ORR) biss u r-rati ta' remissjoni totali kienu aktar għoljin filgrupp BP.
English: In addition, a reduction of tumour burden of over 50% was observed in 78% of the supportive study patients, suggesting a likely clinical benefit for this population.
Maltese: Barra minn hekk, tnaqqis tal-piż tat-tumur ta' aktar minn 50% ġie osservat f'78% tal-pazjenti tal-istudju ta' appoġġ, u dan jissuġġerixxi benefiċċju kliniku possibbli għal din il-popolazzjoni.
English: Therefore, the CHMP considered that the benefit-risk ratio is positive for all applied indications, albeit with different degrees of certainty.
Maltese: Għalhekk, is-CHMP ikkunsidra li lproporzjoni tal-benefiċċji-riskji huwa pożittiv għall-indikazzjonijiet applikati kollha, minkejja gradi differenti ta' ċertezza.
English: Finally, the Applicant noted the characteristic neurotoxicity profiles of recently authorised drugs and emphasized the non-overlapping and well-established toxicity profile of bendamustine (no neurotoxicity) for patients not eligible for thalidomide or bortezomib.
Maltese: Fl-aħħar nett, l-Applikant innota l-profili ta' newrotossiċità karatteristiċi ta' mediċini li ġew awtorizzati reċentement u enfasizza l-profil ta' tossiċità li ma jidħolx fuq oħrajn u li huwa stabbilit sew ta' bendamustine (bla newrotossiċità) għal pazjenti li mhumiex eliġibbli għal thalidomide jew bortezomib.
English: Levact contains bendamustine, an alkylating anti-tumour agent which acts by impairing DNA matrix functions and DNA synthesis and repair.
Maltese: Levact fih bendamustine, aġent alkilanti kontra t-tumuri li jaġixxi billi jfixkel il-funzjonijiet tal-matriċi tad-DNA u s-sinteżi u t-tiswija tad-DNA.
English: “First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.
Maltese: “Trattament tal-bidu ta' lewċemija limfoċitika kronika (Stadju Binet B jew Ċ) f'pazjenti li għalihom ilkimoterapija konġunta b'fludarabine mhijiex xierqa.
English: The CHMP noted the methodological and procedural deficiencies of the submitted trials, and that the primary endpoint and retrospective calculation of PFS rightfully attract criticism, but did not consider the control group to be under-treated.
Maltese: Is-CHMP innota n-nuqqasijiet fil-proċedura u l-metodu tal-provi sottomessi, u li l-punt ta' tmiem primarju u l-kalkolu retrospettiv tal-PFS jattiraw il-kritika bir-raġun, iżda ma kkunsidrax li l-grupp ta' kontroll ma kienx trattat biżżejjed.