FrancophonIA/ELRC3.0 huggingface dataset:
English: The total number of people employed by the Agency at the end of 2008, including regular staff plus contract agents, visiting experts, interims and trainees, was 624, or some 14% more than the 547 employed in 2007.
Maltese: In-numru totali ta' persuni li jaħdmu mal-Aġenzija fl-aħħar tal-2008, inkluż l-istaff regolari flimkien mal-aġenti b'kuntratt, esperti fuq żjara, temporanji u apprendisti, kien ta' 624, jew madwar 14% aktar mill-547 impjegati fl-2007.
English: A total of 1,943 reports of adverse reactions in animals were recorded in EudraVigilance Veterinary in 2008, of which 1,712 related to reactions in companion animals (971 in dogs and 704 in cats) and 231 in food-producing animals (cows, pigs, etc.).
Maltese: Fl-2008, fl-EudraVigilance Veterinary, b'kollox ġew irreġistrati 1,943 rapport ta' reazzjonijiet avversi fl-annimali li minnhom 1,712 kienu jirrigwardaw reazzjonijiet f'annimali ta' kumpanija (971 fi klieb u 704 fi qtates) u 231 f'annimali li jipproduċu l-ikel (baqar, ħnieżer, eċċ.).
English: Positive opinions Applications withdrawn prior to opinion Negative opinions
Maltese: Opinjonijiet pożittivi Applikazzjonijiet irtirati qabel opinjoni Opinjonijiet negattivi
English: Of the 66 medicines to receive a positive opinion from the CHMP in 2008, those that are of particular note include:
Maltese: Mis-66 mediċina li rċevew opinjoni pożittiva mis-CHMP fl-2008, dawk li jistħoqqilhom jissemmew b'mod partikolari jinkludu:
English: Positive opinions Negative opinions Application withdrawals
Maltese: Opinjoniijiet negattivi
English: 6 The European Economic Area includes the 27 Member States of the European Union, plus Iceland, Liechtenstein and Norway.
Maltese: Iż-Żona Ekonomika Ewropea tinkludi s-27 Stat Membru tal-Unjoni Ewropea, flimkien mal-Iżlanda, ilLiechtenstein u n-Norveġja.
English: Type-II (quality) variations
Maltese: Varjazzjonijiet Tip-II (kwalità)
English: 73 related to medicines with a new active substance, i.e. a chemical or biological compound that has not previously been used in an authorised medicine;
Maltese: 73 kienu relatati ma' mediċini b'sustanza attiva ġdida, jiġifieri kimika jew kompost bijoloġiku li ma ntużax qabel f'mediċina awtorizzata;
English: Establishing scientific opinions on herbal medicines
Maltese: L-istabbiliment ta' opinjonijiet xjentifiċi dwar mediċini erbali
English: an anti-rheumatic biological agent (interleukin-6 receptor antagonist) that can be used in combination with methotrexate to treat adults with moderate to severe active rheumatoid arthritis (an immune disease causing inflammation of the joints).
Maltese: sustanza bijoloġika kontra r-rewmatiżmu (antagonista tar-riċettur tal-interleukin-6) li tista' tintuża flimkien ma' methotrexate fil-kura ta' adulti b'artrite rewmatika moderata sa severa (marda immunitarja li tikkawża infjammazzjoni tal-ġogi).
English: Of these:
Maltese: Minn dawn:
English: The Agency's total revenue in 2008 was 182,895,000 euro - slightly over 10% higher than in 2007.
Maltese: Id-dħul totali tal-Aġenzija fl-2008 kien ta' 182,895,000 Euro - ftit aktar minn 10% ogħla milli kien flIt-tabella ta' hawn taħt turi t-tqassim tad-dħul tal-Aġenzija għall-2007 u l-2008, flimkien maċ-ċifri mbassra għall-2009.
English: The medicine concerned was an anti-obesity medicine.
Maltese: Il-mediċina kkonċernata kienet mediċina ta' kontra l-obeżità.
English: preparing and releasing for consultation a policy on appropriate levels of access by regulatory authorities, healthcare professionals, patients, pharmaceutical industry and the general public to information contained in EudraVigilance - the EU's database of adverse reactions to medicines;
Maltese: it-tħejjija u t-tnedija għall-konsultazzjoni ta' politika dwar livelli xierqa ta' aċċess mill-awtoritajiet regolatorji, il-professjonisti fil-kura tas-saħħa, pazjenti, l-industrija farmaċewtika u l-pubbliku ġenerali għal informazzjoni li tinsab fl-EudraVigilance - id-database tal-UE dwar reazzjonijiet avversi għal mediċini;
English: A CHMP opinion is a recommendation to the European Commission on whether or not it should grant a Community marketing authorisation (or licence) that allows the medicine concerned to be placed on the market in all 30 European Economic Area countries (the 27 European Union Member States, plus Iceland, Liechtenstein and Norway).
Maltese: Opinjoni tas-CHMP hija rakkomandazzjoni lill-Kummissjoni Ewropea dwar jekk għandhiex tagħti jew le awtorizzazzjoni Komunitarja għat-tqegħid fis-suq (jew liċenzja) li tippermetti li l-mediċina kkonċernata titpoġġa fis-suq fit-30 pajjiż taż-Żona Ekonomika Ewropea (is-27 Stat Membru tal-Unjoni Ewropea, flimkien mal-Iżlanda, il-Liechtenstein u n-Norveġja).
English: A ‘public-facing online information project' was launched in 2008 to begin a comprehensive overhaul of the Agency's public website.
Maltese: Fl-2008 tnieda ‘Proġett ta' informazzjoni online li tiffaċċja l-pubbliku' sabiex jingħata bidu għarristrutturar komprensiv tal-websajt pubblika tal-Aġenzija.
English: EEA and non-EEA ADR reports received (2006-2008)
Maltese: Applikazzjonijiet ta' wara l-awtorizzazzjoni riċevuti (2006-2008)
English: A further 308 reports related to adverse reactions occurring in humans following exposure to veterinary medicines.
Maltese: 308 rapporti oħra kienu jirrigwardaw reazzjonijiet avversi li seħħew f'persuni wara li dawn kienu esposti għal mediċini veterinarji.
English: One further positive opinion was adopted in favour of granting a conditional marketing authorisation (a one-year authorisation, renewable annually, on condition that certain specific obligations are met), while negative opinions were adopted for 7 applications.
Maltese: Ġiet adottata opinjoni pożittiva oħra favur l-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq kundizzjonata (awtorizzazzjoni għal sena, li tiġġedded kull sena, bil-kundizzjoni li jiġu ssodisfati ċerti obbligi speċifiċi), filwaqt li ġew adottati opinjonijiet negattivi għal 7 applikazzjonijiet.
English: 10 Management Board documents: http://www.emea.europa.eu/htms/general/manage/MB/MB_documents.html
Maltese: Rapport annwali sħiħ tal-attivitajiet li saru fl-2008 huwa disponibbli fuq il-websajt talAġenzija fl-indirizz: http://www.emea.europa.eu/htms/general/direct/ar.htm
English: released for public consultation 14 draft Community herbal monographs for traditional and wellestablished herbal medicines;
Maltese: ħareġ għal konsultazzjoni pubblika 14-il abbozz ta' monografiji Komunitarji ta' mediċini erbali għal mediċini magħmulin minn ħxejjex tradizzjonali u stabbiliti sew;
English: Outcome of initial-evaluation applications (2006-2008)
Maltese: Riżultat ta' applikazzjonijiet ta' evalwazzjoni inizjali (2006-2008)
English: launch of the ENCePP website11, devoted to the activities of the newly created European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by the Agency; creation of a new ‘Regulatory and procedural guidelines' section12 of the Agency's public website,
Maltese: il-ħolqien ta' sezzjoni ġdida ‘Linji gwida regolatorji u proċedurali'12 fil-websajt pubblika tal
English: Assessing applications for orphan designation
Maltese: Il-valutazzjoni ta' applikazzjonijiet għan-nominazzjoni ta' mediċini orfni
English: preparing for the future provision of access to certain data contained in EudraCT - the EU's database of clinical-trial information - and preparing an implementation plan for adapting information-technology systems to allow for such access.
Maltese: it-tħejjija għall-għoti fil-futur ta' aċċess għal ċerta dejta li tinsab fl-EudraCT - id-database tal-UE dwar informazzjoni ta' provi kliniċi - u t-tħejjija ta' pjan ta' implimentazzjoni għall-addattament tas-sistemi teknoloġiċi tal-informazzjoni sabiex dan l-aċċess ikun possibbli.
English: Initial-evaluation applications received (2006-2008)
Maltese: Applikazzjonijiet ta' evalwazzjoni inizjali riċevuti (2006-2008)
English: 31 were type-II variation procedures that resulted in positive opinions from the CHMP on the extension of indication of authorised medicines.
Maltese: 31 kienu proċeduri ta' varjazzjoni tat-tip II li rriżultaw f'opinjonijiet pożittivi mis-CHMP dwar ittwessigħ ta' indikazzjoni ta' mediċini awtorizzati.
English: Type-IB variations
Maltese: Varjazzjonijiet Tip-IB
English: received 5 requests for scientific advice relating to veterinary medicines.
Maltese: irċeviet 5 talbiet għal parir xjentifiku relatati ma' mediċini veterinarji.
English: Type-IA variations
Maltese: Varjazzjonijiet Tip-I
English: Type-I variation notifications Type-II variation opinions Line-extension opinions
Maltese: Opinjonijiet varjazzjoni Tip-II
English: Staffing increased by 14%
Maltese: Il-persunal żdied b'14%
English: Type-II (clinical) variations Line extensions
Maltese: Varjazzjonijiet Tip-II (kliniċi)
English: 3 were for ‘similar biological medicines', i.e. medicines whose active substance is made by, or derived from, a living organism, and is similar to that of a previously authorised medicine.
Maltese: 3 kienu għal ‘mediċini bijoloġiċi simili', jiġifieri mediċini li s-sustanza attiva tagħhom hija magħmula minn, jew meħuda minn, organiżmu ħaj, u hija simili għal dik ta' mediċina awtorizzata preċedentament.
English: a series of exchanges of information with the medicines authorities of the USA, Canada and Japan, within the framework of confidentiality arrangements signed between the EU and these countries;
Maltese: sensiela ta' skambji ta' informazzjoni mal-awtoritajiet tal-mediċini tal-Istati Uniti, tal-Kanada u talĠappun, fil-qafas ta' arranġamenti ta' kunfidenzjalità ffirmati bejn l-UE u dawn il-pajjiżi;
English: Activities carried out in 2008 to provide greater transparency of documents and data controlled by the Agency included:
Maltese: L-attivitajiet li saru fl-2008 sabiex tkun ipprovduta aktar trasparenza tad-dokumenti u tad-dejta kkontrollati mill-Aġenzija kienu jinkludu:
English: 5 The ‘Community list…' is an official list, established by the HMPC and approved by the European Commission, of herbal substances and preparations that have been in medicinal use for a sufficiently long time, and which are therefore considered not to be harmful under normal conditions of use.
Maltese: Il-‘Lista Komunitarja…' hija lista uffiċjali, stabbilita mill-HMPC u approvata mill-Kummissjoni Ewropea, ta' sustanzi u preparazzjonijiet erbali li ilhom fl-użu mediċinali għal żmien twil biżżejjed, u li għalhekk huma kkunsidrati li mhumiex ta' ħsara f'kundizzjonijiet normali ta' użu.
English: In 2008, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted 66 positive opinions1 - the highest number ever adopted in a single year - following its completion of initialevaluation procedures2 for new medicines for human use.
Maltese: Fl-2008, il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta 66 opinjoni pożittiva1 - l-ogħla numru li qatt ġie adottat f'sena waħda - wara li temm il-proċeduri ta' evalwazzjoni inizjali2 għal mediċini ġodda għall-użu mill-bniedem.
English: Volume of post-authorisation procedures finalised for human medicines increased by 13%
Maltese: Il-volum ta' proċeduri ta' wara l-awtorizzazzjoni finalizzati għal mediċini għall-użu millbniedem żdied bi 13%
English: The establishment of the CAT was stipulated in the EU's Advanced Therapies Regulation9 - a new and important piece of legislation that introduces special procedures for the evaluation and authorisation of ‘advanced therapy medicinal products' - medicines derived from gene therapy, somatic cell therapy or tissue engineering - which offer groundbreaking treatment options for patients.
Maltese: ta' ‘prodotti mediċinali ta' terapija avvanzata' - mediċini miksubin minn terapija ta' ġeni, terapija somatika taċ-ċelloli jew inġinerija tat-tessuti - li joffru għażliet ta' kura innovattivi għall-pazjenti.
English: The volume of applications received by the Agency in 2008 for initial evaluation of new veterinary medicines was, at 16 applications, similar to the volume seen in 2007.
Maltese: Il-volum ta' applikazzjonijiet li rċeviet l-Aġenzija fl-2008 għal evalwazzjoni inizjali ta' mediċini veterinarji ġodda kien, b'16-il applikazzjoni, simili għall-volum li deher fl-2007.
English: Public-health benefits of medicines recommended for authorisation in 2008
Maltese: Benefiċċji għas-saħħa pubblika ta' mediċini rakkomandati għall-awtorizzazzjoni fl-2008
English: two medicines used to prevent the formation of venous thromboembolism (blood clots in the veins), which can be administered orally and therefore provide an alternative to conventional therapy by injection.
Maltese: żewġ mediċini użati għall-prevenzjoni tal-formazzjoni ta' tromboemboliżmu tal-vini (emboli taddemm fil-vini), li jistgħu jingħataw b'mod orali u għalhekk jipprovdu alternattiva għall-kura konvenzjonali permezz ta' injezzjoni.
English: These reports cover all adverse reactions (unwanted side-effects) that have been observed, whether within the European Economic Area (EEA)6 or elsewhere in the world, and concern both centrally authorised7 and non-centrally authorised medicines (shown as ‘CAP' and ‘non-CAP', respectively, in the chart below).
Maltese: Dawn ir-rapporti jkopru r-reazzjonijiet avversi kollha (effetti sekondarji mhux mixtieqa) li ġew osservati, kemm fiż-Żona Ekonomika Ewropea (ŻEE)6 kif ukoll f'inħawi oħrajn fid-dinja, u jikkonċernaw kemm mediċini awtorizzati ċentralment7 kif ukoll dawk li mhumiex awtorizzati ċentralment (murija bħala ‘CAP' u ‘non-CAP', rispettivament, fiċ-ċart ta' hawn taħt).
English: Efforts made in 2008 to further enhance the involvement of healthcare professionals, patients and consumers in the Agency's activities included: extending the scope of patients' and consumers' involvement in reviewing the quality of package leaflets (the information contained in the package of a medicine); working with patients and consumers to establish, by means of a survey, their level of satisfaction with their current involvement in the activities of the Agency; integrating input received from healthcare professionals, patients and consumers in the development of the Agency's communications strategy.
Maltese: Ix-xogħol ta' evalwazzjoni relatat mal-mediċini pedjatriċi, mediċini għal mard rari, mediċini magħmula mill-ħxejjex u mediċini veterinarji kien intensiv ukoll fl-2008, filwaqt li l-volum ta' xogħol relatat malgħoti ta' pariri xjentifiċi, l-abbozzar ta' linji gwida, l-ipproċessar ta' applikazzjonijiet ta' varjazzjoni u lmod kif tmexxew l-attivitajiet ta' farmakoviġilanza kien raġonevolment għoli inġenerali.
English: Improving the Agency's web communications
Maltese: Programmi tal-Komunità
English: a medicine to treat hyperphenylalaninaemia (high levels of phenylalanine in the blood) in patients with the genetic disorders phenylketonuria or tetrahydrobiopterin deficiency.
Maltese: ingħataw aktar opinjonijiet pożittivi dwar nominazzjoni ta' mediċini orfni li jirrigwardaw mediċini ta' kontra l-kanċer milli kull tip ta' mediċina oħra;
English: received 320 new or follow-up requests for scientific advice or protocol assistance relating to medicines for human use;
Maltese: irċeviet 320 talba ġdida jew ta' segwitu għal parir xjentifiku jew assistenza għall-protokoll relatati ma' mediċini għall-użu mill-bniedem;
English: The majority of positive CHMP opinions adopted in 2008 related to cancer medicines, followed by antiinfectives and medicines for the treatment of neurological and central-nervous-system conditions.
Maltese: Il-parti l-kbira tal-opinjonijiet pożittivi tas-CHMP adottati fl-2008 kienu relatati ma' mediċini kontra lkanċer, segwiti minn anti-infettivi u mediċini għall-kura ta' kundizzjonijiet newroloġiċi u tas-sistema nervuża ċentrali.
English: CAP EEA reports CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
Maltese: Ir-Renju Unit Oħrajn
English: ‘Orphan' medicines are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect not more than five in 10,000 persons in the European Union.
Maltese: Il-mediċini ‘Orfni' huma maħsubin għad-dijanjożi, il-prevenzjoni jew il-kura ta' kundizzjonijiet li jipperikolaw il-ħajja jew li huma kronikament debilitanti u li jaffettwaw lil mhux aktar minn ħamsa minn kull 10,000 persuna fl-Unjoni Ewropea.
English: Line-extension applications relate to changes to the active substance(s), strength, pharmaceutical form (e.g. powder, ointment or tablet) or route of administration (e.g. oral, intravenous or subcutaneous) of an authorised medicine.
Maltese: L-applikazzjonijiet għal estensjoni tal-linja jirrigwardaw bidliet fis-sustanza(i) attiva(i), il-qawwa, il-forma farmaċewtika (eż. trab, ingwent jew pillola) jew f'minn fejn tingħata (eż. orali, minn ġolvina jew minn taħt il-ġilda) ta' mediċina awtorizzata.
English: Small and medium-sized enterprises (SMEs) operating in the human and veterinary pharmaceutical sectors are often innovators of new technologies and emerging therapies.
Maltese: L-intrapriżi ż-żgħar u ta' daqs medju (SMEs) li joperaw fis-setturi farmaċewtiċi tal-bniedem u veterinarji huma spiss innovaturi ta' teknoloġiji ġodda u kuri emerġenti.
English: The role of the Agency is to prepare, through its Committee on Herbal Medicinal Products (HMPC), scientific opinions on the quality, safety and efficacy of such medicines, so that regulatory information relating to them can be harmonised across the EU.
Maltese: Ir-rwol tal-Aġenzija huwa li tħejji, permezz tal-Kumitat tagħha għall-Prodotti Mediċinali Erbali (HMPC), opinjonijiet xjentifiċi dwar il-kwalità, is-sigurtà u l-effikaċja ta' mediċini bħal dawn, sabiex linformazzjoni regolatorja li jkollha x'taqsam magħhom tkun tista' tiġi armonizzata madwar l-UE.
English: 4 A herbal monograph is a collection of all relevant information concerning a herbal medicine, including its composition, use, safety precautions, etc.
Maltese: Monografija tal-mediċini erbali hija ġabra tal-informazzjoni kollha rilevanti li tikkonċerna mediċina magħmula mill-ħxejjex, inkluż il-kompożizzjoni tagħha, l-użu, il-prekawzjonijiet ta' sigurtà, eċċ.
English: Explanation of post-authorisation categories:
Maltese: Spjegazzjoni ta' kategoriji ta' wara l-awtorizzazzjoni:
English: A total of 2,246 applications relating to post-authorisation activities concerning medicines for human use were received in 2008 - a 10% increase on the number received in the previous year.
Maltese: Fl-2008, waslu b'kollox 2,246 applikazzjoni li jirrigwardaw attivitajiet ta' wara l-awtorizzazzjoni li jikkonċernaw mediċini għall-użu mill-bniedem - żieda ta' 10% fuq in-numru li ntlaqa' s-sena ta' qabel.
English: All 13 procedures resulted in a positive opinion being adopted by the Agency's Committee for Medicinal Products for Veterinary Use (CVMP).
Maltese: It-13-il proċedura rriżultaw fl-adozzjoni ta'opinjoni pożittiva mill-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP).
English: 119 orphan-designation applications were submitted to the Agency;
Maltese: l-Aġenzija rċeviet 119-il applikazzjoni għan-nominazzjoni ta' mediċini orfni;
English: a medicine for use in adults with long-term immune thrombocytopenic purpura, a rare disease in which the patient's immune system destroys the blood platelets that help blood to clot whenever the person bleeds.
Maltese: mediċina għall-użu fl-adulti b'purpura tromboċitopenika immuni fuq żmien twil, marda rari fejn issistema immunitarja tal-pazjent teqred il-pjastrini tad-demm li jgħinu lid-demm jagħqad kull meta l-persuna tesperjenza fsada.
English: Evaluating medicines for veterinary use Thirteen positive opinions adopted for new veterinary medicines
Maltese: L-evalwazzjoni tal-mediċini għal użu veterinarju Tlettax-il opinjoni pożittiva adottati għal mediċini veterinarji ġodda
English: 11 ENCePP website: http://www.encepp.eu
Maltese: It-tisħiħ tan-netwerk Ewropew tal-mediċini
English: Besides monitoring adverse-reaction reports, the Agency also reviews periodic safety update reports that marketing-authorisations holders are obliged to submit in respect of their centrally authorised medicines.
Maltese: Minbarra li timmonitorja r-rapporti dwar reazzjonijiet avversi, l-Aġenzija tirrevedi wkoll rapporti perjodiċi aġġornati ta' sigurtà li d-detenturi ta' awtorizzazzjoni għat-tqegħid fis-suq huma obbligati li jissottomettu fir-rigward tal-mediċini awtorizzati ċentralment tagħhom.
English: finalised a record number of 328 scientific-advice and protocol-assistance requests relating to medicines for human use (up 14% on the number of requests finalised in 2007);
Maltese: mediċini għall-użu mill-bniedem (14% aktar fuq in-numru ta' talbiet iffinalizzati fl-2007);
English: participation in a series of projects being run by the World Health Organization, notably the ‘Make medicines child size' programme aimed at addressing the need for improved availability of safe medicines for children;
Maltese: parteċipazzjoni f'sensiela ta' proġetti mmexxija mill-Organizzazzjoni Dinjija tas-Saħħa, l-aktar filprogramm ‘Nagħmlu l-mediċini d-daqs tat-tfal' bl-għan li jindirizza l-ħtieġa ta' disponibbiltà akbar ta' mediċini siguri għat-tfal;
English: Applications for approval of PIPs, waivers and PUMAs are assessed by the Agency's Paediatric Committee, which also conducts compliance-checks to verify that companies applying for a marketing authorisation have developed their medicine in accordance with their approved PIP.
Maltese: L-applikazzjonijiet għall-approvazzjoni ta' PIPs, rinunzji u PUMAs jiġu vvalutati mill-Kumitat Pedjatriku tal-Aġenzija, li jagħmel ukoll kontrolli ta' konformità sabiex jivverifika li l-kumpaniji li jkunu qegħdin japplikaw għal awtorizzazzjoni għat-tqegħid fis-suq żviluppaw il-mediċina tagħhom skont il-PIP approvat tagħhom.
English: Of the 103 applications received in 2008:
Maltese: Mill-103 applikazzjonijiet li waslu fl-2008:
English: a new compound in an existing class of antiretroviral medicines that can be used to treat adults infected with HIV-1 (the virus that causes AIDS) in whom treatment with other medicines in the same class has been unsuccessful.
Maltese: kompost ġdid fi klassi eżistenti ta' mediċini antiretrovirali li jista' jintuża għall-kura ta' adulti infettati bl-HIV-1 (il-virus li jikkawża AIDS), li meta dawn l-adulti ġew ikkurati b'mediċini oħrajn tal-istess klassi, il-kura ma kellhiex suċċess.
English: 46 were for generic or hybrid medicines, i.e. medicines whose active substance is essentially the same as that of a previously authorised medicine;
Maltese: 46 kienu għal mediċini ġeneriċi jew ibridi, jiġifieri mediċini li s-sustanza attiva tagħhom hija essenzjalment l-istess bħal dik ta' mediċina awtorizzata preċedentament;
English: The number of initial-evaluation applications submitted to the Agency in 2008 for evaluation of new medicines for use in humans was 103 - a 14% increase on the number received in 2007.
Maltese: L-għadd ta' applikazzjonijiet għal evalwazzjoni inizjali ppreżentati lill-Aġenzija fl-2008 għallevalwazzjoni ta' mediċini ġodda għall-użu fil-bnedmin kien ta' 103 - żieda ta' 14% fuq in-numru li wasal fl-2007.
English: the first medicine for use as maintenance treatment in adults with acute myeloid leukaemia (a type of cancer affecting the white blood cells), in combination with interleukin-2 (an anticancer medicine).
Maltese: l-ewwel mediċina għall-użu bħala kura ta' manteniment f'adulti b'lewkimja majelojde akuta (tip ta' kanċer li jaffettwa ċ-ċelloli tad-demm bojod), flimkien ma' interleukin-2 (mediċina ta' kontra lkanċer).
English: The CHMP will process these applications within 210 days, as stipulated in EU legislation, and adopt opinions in each case as to whether or not it recommends that a marketing authorisation should be granted.
Maltese: Is-CHMP sejjer jipproċessa dawn l-applikazzjonijiet fi żmien 210 t'ijiem, kif stipulat fil-leġiżlazzjoni tal-UE, u sejjer jadotta opinjonijiet f'kull każ dwar jekk jirrakkomandax jew le li tingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In 2008, the Agency reviewed 391 such reports relating to medicines for human use and 91 relating to veterinary medicines.
Maltese: Fl-2008, l-Aġenzija irrivediet 391 rapport bħal dawn relatati ma' mediċini għall-użu mill-bniedem u 91 relatati ma' mediċini veterinarji.