FrancophonIA/ELRC3.0 huggingface dataset:
English: Dukoral should be given according to official recommendations, taking into account where cholera is found and the risk of contracting the disease.
Maltese: Dukoral għandu jingħata skont ir-rakkomandazzjonijiet uffiċjali, filwaqt li jitqies fejn tinstab il-kolera u r-riskju tat-teħid tal-marda.
English: In the first of the two studies in Peru, the protective effectiveness of Dukoral was 85% for the first five months of follow-up.
Maltese: Fl-ewwel studju miż-żewġ studji fil-Perù, l-effikaċja protettiva ta' Dukoral kienet 85% għall-ewwel ħames xhur ta' sorveljanza.
English: A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found.
Maltese: Sar studju ulterjuri biex juri li Dukoral ikun jista' jipproduċi antikorpi f'persuni li ma jkunux minn żoni fejn tinsab il-kolera.
English: For the full list of side effects reported with Dukoral, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Dukoral, ara l-fuljett ta' tagħrif.
English: When a person is given the vaccine, the immune system recognises the bacteria and the toxin, and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-batterju u t-tossin, u tagħmel l-antikorpi kontrihom.
English: The company also presented data from the published literature.
Maltese: Il-kumpanija ppreżentat ukoll dejta milletteratura ppubblikata.
English: The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru.
Maltese: Iż-żewġ studji l-oħra qabblu Dukoral (li fih it-tossin tal-kolera rikombinanti) ma' plaċebo f'aktar minn 22,000 ruħ fil-Perù.
English: Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is caught from contaminated food or water and causes severe diarrhoea).
Maltese: Dukoral jintuża bħala protezzjoni kontra l-kolera (marda serja ħafna kkawżata minn V. cholerae, li tittieħed minn ikel jew ilma kkontaminat u li tikkawża dijarea severa).
English: This subunit is not toxic by itself.
Maltese: Dan is-subunit mhuwiex tossiku fih innifsu.
English: What benefit has Dukoral shown during the studies?
Maltese: Liema benefiċċju wera Dukoral matul l-istudji mwettqa?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to protect itself against a disease.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (id-difiżi naturali talġisem) kif tipproteġi ruħha kontra marda.
English: In adults and children from six years of age, Dukoral is given as two doses, one to six weeks apart.
Maltese: Fl-adulti u fit-tfal minn sitt snin 'il fuq, Dukoral jingħata f'żewġ dożi, b'bejn ġimgħa u sitt ġimgħat.
English: Further information on Brinavess can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/brinavess.
Maltese: ema.europa.eu/medicines/human/EPAR/brinavess.
English: Brinavess contains the active substance vernakalant hydrochloride.
Maltese: Brinavess fih is-sustanza attiva kloridrat tal-vernakalant.
English: Brinavess is a solution that is given by infusion (drip) into a vein over a period of 10 minutes.
Maltese: Brinavess huwa soluzzjoni li tingħata permezz ta' infużjoni (dripp) ġol-vina fuq perjodu ta' 10 minuti.
English: In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo.
Maltese: Fl-ewwel żewġ studji, fost il-pazjenti li reċentement beda jkollhom fibrillazzjoni atrijali, ir-ritmu tal-qalb reġa' lura għan-normal f'51 % ta' dawk li kienu qed jirċievu Brinavess (118 minn 231) meta mqabbel ma' 4 % (6 minn 159) ta' dawk li kienu qed jieħdu l-plaċebo.
English: Patients should not be given more than 5 mg of Brinavess per kg body weight within any 24-hour period, or a maximum of 565 mg in patients weighing more than 113 kg.
Maltese: Ilpazjenti m'għandhomx jingħataw aktar minn 5 mg ta' Brinavess għal kull kg ta' piż tal-ġisem fi kwalunkwe perjodu ta' 24 siegħa, jew massimu ta' 565 mg f'pazjenti li jiżnu aktar minn 113 kg.
English: In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.
Maltese: Fit-tielet studju, ir-ritmu tal-qalb reġa' lura għan-normal f'47 % tal-pazjenti li kienu qed jirċievu Brinavess meta mqabbla ma' 14 % ta' dawk li kienu qed jirċievu l-plaċebo.
English: A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery.
Maltese: It-tielet studju ewlieni qabbel il-Brinavess ma' plaċebo f'161 adult li kellhom fibrillazzjoni atrijali wara kirurġija tal-qalb.
English: Brinavess received a marketing authorisation valid throughout the European Union on 01 September
Maltese: Brinavess irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fl-01 ta' Settembru 2010.
English: Brinavess contains vernakalant, a type of substance known as an anti-arrhythmic.
Maltese: Brinavess fih l-vernakalant, tip ta' sustanza magħrufa bħala antiaritmika.
English: Other information about Brinavess
Maltese: Informazzjoni oħra dwar Brinavess
English: Brinavess must not be given within 30 days of having acute coronary syndrome (a group of heart problems that include unstable angina and heart attacks).
Maltese: Brinavess m'għandux jingħata fi żmien 30 jum minn sindromu koronarju akut (grupp ta' problemi tal-qalb li jinkludu anġina instabbli u attakki tal-qalb).
English: In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment).
Maltese: F'żewġ studji ewlenin li kienu jinvolvu 596 adult b'fibrillazzjoni atrijali, Brinavess tqabbel ma' plaċebo (kura finta).
English: Brinavess must not be used in patients with severe aortic stenosis (narrowing of the aorta), low systolic blood pressure (blood pressure when the heart is contracting), advanced heart failure (when the heart does not pump enough blood around the body), some types of altered electrical activity in the heart or a very slow heart rate.
Maltese: Brinavess m'għandux jintuża f'pazjenti b'stenożi aortika severa (tidjiq tal-aorta), pressjoni tad-demm sistolika baxxa (pressjoni tad-demm meta l-qalb tkun qed tiċkien), insuffiċjenza kardijaka avvanzata (meta l-qalb ma tippompjax biżżejjed demm madwar il-ġisem), xi tipi ta' attività elettrika mibdula filqalb jew rata tal-qalb baxxa ħafna.
English: Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm.
Maltese: Il-fibrillazzjoni atrijali sseħħ meta l-atrija (ilkavitajiet ta' fuq tal-qalb) tikkuntratta b'mod irregolari u rapidu, u dan jirriżulta f'ritmu tal-qalb anormali.
English: By blocking these channels, vernakalant can prevent abnormal electrical activity that can lead to atrial fibrillation.
Maltese: Billi timblokka dawn il-kanali, il-vernakalant tista' tipprevjeni attività elettrika anormali li tista' twassal għal fibrillazzjoni atrijali.
English: Brinavess is a medicine used to rapidly restore normal heart rhythm in adult patients who have recently started having atrial fibrillation.
Maltese: Brinavess huwa mediċina li tintuża biex treġġa' lura b'mod rapidu r-ritmu normali tal-qalb f'pazjenti adulti li reċentement beda jkollhom fibrillazzjoni atrijali.
English: It restores normal heart rhythm by blocking channels through which charged particles of potassium and sodium move in and out of the muscle cells in the atria.
Maltese: Din treġġa' lura r-ritmu talqalb normali billi timblokka l-kanali li permezz tagħhom il-partikuli ċċarġjati tal-potassju u tas-sodju jimxu 'l ġewwa u 'l barra miċ-ċelloli tal-muskoli fil-atria.
English: Side effects reported with Brinavess are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Brinavess huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The most common side effects with Brinavess (which may affect more than 1 person in 10) are dysgeusia (taste disturbances) and sneezing.
Maltese: L-effetti sekondarji l-aktar komuni bi Brinavess (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma disgewsija (disturbi fit-togħma) u għatis.
English: As for all medicines, data on the use of Brinavess are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Brinavess hija ssorveljata kontinwament.
English: The healthcare professional should monitor the patient's blood pressure and heart rate while the medicine is being given and for at least 15 minutes afterwards.
Maltese: Ilprofessjonista fil-qasam tal-kura tas-saħħa għandu jissorvelja l-pressjoni tad-demm u r-rata tal-qalb tal-pazjent waqt li l-mediċina tkun qed tingħata u għal mill-inqas 15-il minuta wara.
English: What are the risks associated with Brinavess?
Maltese: Kif jaħdem Brinavess?
English: Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation.
Maltese: Brinavess kien aktar effettiva mill-plaċebo fil-kura tal-pazjenti li reċentement beda jkollhom fibrillazzjoni atrijali.
English: How is Brinavess used?
Maltese: Brinavess?
English: Patients on Brinavess must not be given medicines called ‘class I and III anti-arrhythmics' intravenously during the four hours before or after their Brinavess infusion.
Maltese: Il-pazjenti li qed jieħdu Brinavess m'għandhomx jingħataw mediċini msejħin “antiaritmiċi tal-klassi I u III” fil-vina matul l-erba' sigħat ta' qabel jew wara l-infużjoni ta' Brinavess tagħhom.
English: Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).
Maltese: Il-vernakalant taġixxi prinċipalment fil-atria aktar milli fil-ventrikli (il-kavitajiet ta' isfel tal-qalb).
English: For the full list of side effects of Brinavess, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Brinavess, ara l-fuljett ta' tagħrif.
English: If the heart rhythm has not returned to normal 15 minutes after the end of the first infusion, a second, smaller dose may be given.
Maltese: Jekk ir-ritmu tal-qalb ma jkunx reġa' lura għan-normal 15-il minuta wara t-tmiem tal-ewwel infużjoni, tista' tingħata t-tieni doża iżgħar.
English: The European Medicines Agency decided that Brinavess's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Brinavess huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: The full EPAR and risk management plan summary for Mysimba 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 Mysimba
Maltese: Informazzjoni oħra dwar Mysimba
English: In three of the studies, the average weight loss in patients treated with Mysimba was around 3.7 to 5.7%, compared with 1.3 to 1.9% with placebo; the proportion of Mysimba-treated patients who achieved 5% weight loss ranged from 28 to 42% compared with 12 to 14% with placebo.
Maltese: Fi tliet studji minnhom, il-medja ta' tnaqqis fil-piż f'pazjenti kkurati b'Mysimba kienet madwar 3.7 sa 5.7%, meta mqabbel ma' 1.3 sa 1.9% bi plaċebo; il-proporzjon ta' pazjenti kkurati b'Mysimba li laħqu tnaqqis fil-piż ta' 5% varja minn 28 sa 42% meta mqabbel ma' 12 sa 14% bi plaċebo.
English: Mysimba is available as prolonged-release tablets containing 7.2 mg naltrexone and 78 mg bupropion and can only be obtained with a prescription.
Maltese: Mysimba jiġi bħala pilloli b'rilaxx fit-tul li fihom 7.2 mg naltrexone u 78 mg bupropion u jista' jinkiseb biss b'riċetta ta' tabib.
English: This is a summary of the European public assessment report (EPAR) for Mysimba.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Mysimba.
English: Why is Mysimba approved?
Maltese: Għaliex ġie approvat Mysimba?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mysimba on 26 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Mysimba fis-26 ta' Marzu 2015.
English: Some 46% and 30% of patients given Mysimba achieved 5 and 10% weight reductions respectively, compared with 34% and 17% respectively with placebo.
Maltese: Xi 46% u 30% tal-pazjenti li ngħataw Mysimba laħqu tnaqqis fil-piż ta' 5% u 10% rispettivament, meta mqabbel ma' 34% u 17% rispettivament bi plaċebo.
English: What are the risks associated with Mysimba?
Maltese: X'inhuma r-riskji assoċjati ma' Mysimba?
English: About 13 to 22% of those taking Mysimba achieved at least a 10% reduction in weight, while 5 to 6% of placebotreated patients did so.
Maltese: Madwar 13 sa 22% ta' dawk li jieħdu Mysimba laħqu tal-anqas tnaqqis ta' 10% fil-piż, filwaqt li 5 sa 6% tal-pazjenti kkurati bi plaċebo laħqu dan.
English: In the other study, in which patient counselling was also more intensive, the overall weight loss was greater over the study period: 8.1% with Mysimba and 4.9% with placebo.
Maltese: Fi studju ieħor, fejn il-pazjenti ngħataw ukoll aktar pariri, it-tnaqqis globali fil-piż kien akbar matul ilperjodu ta' studju: 8.1% b'Mysimba u 4.9% bi plaċebo.
English: The effects of Mysimba in reducing body weight have been shown in 4 main studies involving around 4,500 obese or overweight patients, in which Mysimba was compared with placebo (a dummy treatment).
Maltese: L-effetti ta' Mysimba fit-tnaqqis tal-piż tal-ġisem intwerew f'4 studji ewlenin li involvew madwar 4,500 pazjent obeżi jew b'piż żejjed, li fihom Maysimba tqabbel ma' plaċebo (kura finta).
English: Mysimba contains the active substances naltrexone and bupropion, which are licensed individually in the EU for other uses.
Maltese: Mysimba fih is-sustanzi attivi naltrexone u bupropion, li huma liċenzjati individwalment fl-UE għal użi oħrajn.
English: On the balance of the available evidence the CHMP decided that Mysimba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Meta titqies l-evidenza disponibbli, is-CHMP iddeċieda li l-benefiċċji ta' Mysimba huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Mysimba is a medicine used along with diet and exercise to help manage weight in adults:
Maltese: Mysimba huwa mediċina użata flimkien ma' dieta u eżerċizzju biex tgħin timmaniġġja l-piż fl-adulti:
English: • who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, or high blood pressure.
Maltese: • li għandhom piż żejjed (għandhom BMI bejn 27 u 30) u kumplikazzjonijiet relatati mal-piż bħal dijabete, livelli għoljin mhux normali ta' xaħam fid-demm, jew pressjoni tad-demm għolja.
English: Interim data from an ongoing study of cardiovascular outcomes were reviewed during the assessment although the CHMP also recommended ongoing monitoring of the medicine's cardiovascular effects.
Maltese: Id-dejta interim minn studju li għadu għaddej ta' eżiti kardjovaskulari kienet irriveduta matul il-valutazzjoni għalkemm is-CHMP irrakkomanda wkoll monitoraġġ kontinwu tal-effetti kardjovaskulari tal-mediċina.
English: The most common side effects with Mysimba (which may affect more than 1 in 10 people) are nausea and vomiting (feeling and being sick) and constipation; dizziness and dry mouth were also common (seen in up to 1 patient in 10).
Maltese: L-effetti sekondarji l-aktar komuni b'Mysimba (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawsja u rimettar (tħossok u tkun ma tiflaħx) u stitikezza; sturdament u ħalq xott kienu komuni wkoll (osservati sa persuna 1 minn kull 10).
English: The main measures of effectiveness were the percentage reduction in body weight over 28 or 56 weeks of treatment, and the proportion of patients who achieved at least a 5% weight reduction; the studies also looked at the number of patients who achieved at least a more stringent 10% reduction in weight, and the results were analysed using various methods to take account of the number of patients who did not complete the studies (around 50% over one year).
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tnaqqis perċentwali fil-piż tal-ġisem fuq medda ta' 28 jew 56 ġimgħa ta' kura, u l-proporzjon ta' pazjenti li laħqu tal-anqas tnaqqis fil-piż ta' 5%; l-istudji eżaminaw ukoll in-numru ta' pazjenti li laħqu tal-anqas tnaqqis aktar strett ta' 10% filpiż, u r-riżultati ġew analizzati permezz ta' diversi metodi biex jitqies in-numru ta' pazjenti li ma lestewx l-istudji (madwar 50% fuq medda ta' sena).
English: The exact way that Mysimba works is not fully understood, but the two active substances, naltrexone and bupropion, act on the parts of the brain that control food intake and energy balance, as well as reducing the effect of the part of the brain that controls the pleasure associated with eating food.
Maltese: Mysimba ma għandux jintuża f'ċerti pazjenti f'riskju partikolari ta' effetti sekondarji, inkluż pazjenti b'indeboliment qawwi fil-funzjoni tal-kliewi jew tal-fwied, dawk bi pressjoni għolja tad-demm li ma tkunx taħt kontroll, dawk li xi darba kellhom aċċessjonijiet (puplesiji), ċerti problemi psikoloġiċi jew li għandhom tumur tal-moħħ jew li qegħdin jieqfu jixorbu jew jieħdu ċerti drogi.
English: The degree of improvement with Mysimba over placebo was similar using different methods of analysis, although the benefits were smallest with the most conservative methods that assumed patients who did not complete the study would not have seen any improvement.
Maltese: Il-grad ta' titjib b'Mysimba meta mqabbel ma' plaċebo kien simili permezz ta' metodi ta' analiżi differeti, għalkemm il-benefiċċji kienu l-iżgħar bil-metodi l-aktar konservattivi li assumew li l-pazjenti li ma jkunux temmew l-istudju ma jkunu raw l-ebda titjib.
English: This summary was last updated in 03-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fit-03-2015.
English: Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.
Maltese: Il-pazjenti flistudji ngħataw il-mediċina bħala parti mill-programm ta' tnaqqis fil-piż li kien jinvolvi konsulenza u pariri dwar dieta u eżerċizzju.
English: Regarding safety, although the CHMP had some concerns about possible effects on the heart and blood vessels (cardiovascular outcomes) and a slightly increased risk of seizures (fits), the most common side effects were largely manageable, as patients could stop taking the medicine if they were bothersome.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Mysimba jintuża bl-aktar mod sigur possibbli.
English: What measures are being taken to ensure the safe and effective use of Mysimba?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mysimba?
English: In addition, the company that markets Mysimba will produce an information pack for doctors prescribing the medicine, including guidance on stopping treatment in patients who do not respond or if there are concerns about side effects.
Maltese: Barra minn hekk, il-kumpanija li tikkummerċjalizza Mysimba ser tipproduċi pakkett ta' informazzjoni għat-tobba li jiktbu r-riċetta għall-mediċina, inkluż gwida dwar it-twaqqif tal-kura f'pazjenti li ma jirrispondux jew jekk ikun hemm tħassib dwar l-effetti sekondarji.
English: For the full list of all side effects reported with Mysimba, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Mysimba, ara l-fuljett ta' tagħrif.
English: 26 July 2012
Maltese: 26 ta' Lulju 2012
English: The full European Public Assessment Report for Velcade 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 has been authorised in the EU since April 2004.
Maltese: Ilu awtorizzat fl-UE sa minn April 2004.
English: The active substance in Velcade, bortezomib, is a proteasome inhibitor.
Maltese: Is-sustanza attiva fi Velcade, bortezomib, hija inibitur ta' proteasome.
English: Velcade was also expected to be used in follicular non-Hodgkin lymphoma (a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells), in combination with another medicine called rituximab in patients whose disease had relapsed (returned after treatment).
Maltese: Velcade kien mistenni li jintuża fil-limfoma follikulari mhux ta' Hodgkin (kanċer tat-tessut limfatiku (parti mis-sistema immuni) li taffettwa tip ta' ċelloli bojod tad-demm magħrufa bħala limfoċti B, jew ċelloli B), f'kombinazzjoni ma' mediċina oħra msejħa rituximab f'pazjenti li l-marda tagħhom tkun irkadiet (reġgħet tfaċċat wara l-kura).
English: What was Velcade expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Velcade?
English: It is used to treat patients with multiple myeloma (a cancer of the plasma cells in the bone marrow).
Maltese: Jintuża fil-kura ta' pazjenti b'majeloma multipla (kanċer taċ-ċelloli tal-plasma fil-mudullun).
English: The Committee considered that this difference was unlikely to be relevant and was not convinced that a sub-group of patients had been identified who would benefit more from the addition of Velcade to rituximab.
Maltese: Il-Kumitat ikkunsidra li din id-differenza ma kinitx probabbli li tkun rilevanti u ma kienx konvint li kien ġie identifikat sottogrupp ta' pazjenti li kieku kienu jibbenefikaw aktar miż-żieda ta' Velcade ma' rituximab.
English: The CHMP was also concerned that the combination of Velcade and rituximab caused more side effects than rituximab alone.
Maltese: Is-CHMP kellu wkoll tħassib li lkombinazzjoni ta' Velcade u ta' rituximab kkawżat aktar effetti sekondarji minn rituximab waħdu.
English: The CHMP questioned the relevance of the study results which showed that, overall, patients treated with Velcade plus rituximab lived without their disease getting worse for an average of 1.8 months longer than patients treated with rituximab alone (12.8 months compared with 11 months).
Maltese: Is-CHMP kellu dubju dwar ir-rilevanza tar-riżultati tal-istudju li wrew li, b'mod ġenerali, pazjenti li rċevew kura bi Velcade flimkien ma' rituximab għexu medja ta' 1.8 xhur aktar minn pazjenti li rċevew kura b'rituximab waħdu mingħajr mal-marda tagħhom marret għall-agħar (12.8 xhur meta mqabbla ma' 11-il xahar).
English: On 2 July 2012, Janssen-Cilag International N.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation of Velcade, which would have extended its use to patients with relapsed follicular non-Hodgkin lymphoma.
Maltese: Fit-2 ta' Lulju 2012, Janssen-Cilag International N.V. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għal tibdil flawtorizzazzjoni għat-tqegħid fis-suq għal Velcade, kieku kienet testendi l-użu tiegħu għal pazjenti b'limfoma follikulari mhux ta' Hodgkin li kienu rkadew.
English: The applicant presented the results of a study involving 676 patients with follicular non-Hodgkin lymphoma that had relapsed or progressed despite previous treatments, designed to assess the effects of using Velcade in combination with rituximab compared with using rituximab alone in these patients.
Maltese: L-applikant ippreżenta r-riżultati ta' studju li fih ħadu sehem 676 pazjent bil-limfoma follikulari mhux ta' Hodgkin li kienet irkadiet jew avvanzat minkejja kura preċedenti, li kien iddisinjat biex jevalwa leffetti tal-użu ta' Velcade f'kombinazzjoni ma' rituximab meta mqabbel mal-użu ta' rituximab waħdu f'dawn il-pazjenti.