FrancophonIA/ELRC3.0 huggingface dataset:
English: Initial-evaluation applications by type of application, 2004-2006
Maltese: Applikazzjonijiet ghal valutazzjoni inizjali skond it-tip ta' applikazzjoni, 2004-2006
English: Facilitating innovation and stimulating research, hence contributing to the competitiveness of EU-based pharmaceutical industry.
Maltese: Tiffaċilità l-innovazzjoni u tistimola r-riċerka, b'hekk tikkontribwixxi għall-kompetittività ta' lindustrija farmaċewtika bbażata fl-UE.
English: The EMEA contributed towards the preparation of the new Paediatric Regulation2, which was published in December 2006.
Maltese: L-EMEA kkontribwixxiet għall-preparazzjoni tal-Regolament Pedjatriku ġdid2, li ġie ppublikat f'Diċembru ta' l-2006.
English: EMEA MISSION STATEMENT
Maltese: DIKJARAZZJONI TAL-MISSJONI TA' L-EMEA
English: The concept of risk-management plans (RMPs) was fully implemented in 2006 as part of the new legislative provisions of Regulation (EC) No 726/2004.
Maltese: Il-kunċett tal-pjanijiet ta' ġestjoni tar-riskji (RMPs) ġie implimentat b'mod sħiħ fl-2006, bħala parti mid-dispożizzjonijiet leġiżlattivi l-ġodda tar-Regolament (KE) Nru 726/2004.
English: INSPECTIONS
Maltese: Lista
English: Withdrawals
Maltese: Irtirati
English: The highest numbers of requests received concerned medicinal products for conditions related to cancer or the nervous system, with those relating to the alimentary tract and metabolism forming the third most-represented therapeutic area.
Maltese: L-ogħla numri ta' talbiet riċevuti ikkonċernaw prodotti mediċinali għal kondizzjonijiet relatati malkanċer jew mas-sistema nervuża, u dawk relatati mal-kanal alimentari u l-metaboliżmu jifformaw ittielet l-aktar qasam irrappreżentat.
English: The Agency subsequently accepted a place in the coordination group set up to convert those parts of the agenda dealing with regulatory issues into an action plan.
Maltese: Sussegwentement, l-Aġenzija aċċettat post fil-grupp ta' koordinazzjoni mwaqqaf biex jikkonverti dawk il-partijiet ta' l-aġenda li jittrattaw kwistjonijiet regolatorji, fi pjan ta' azzjoni.
English: The Committee released for public consultation 2 new draft entries to the Community list, for bitter fennel fruit and sweet fennel fruit.
Maltese: Il-Kumitat ħareġ għall-konsultazzjoni pubblika 2 abbozzi ġodda ta' dħul fil-lista Komunitarja, għallfrott tal-bużbież morr u frott tal-bużbież ħelu.
English: Centrally authorised recombinant hepatitis B vaccines (HBVAXPRO and Procomvax), in relation to the efficacy of the vaccines.
Maltese: Tilqim ta' l-epatite tat-tip B rikombinanti awtorizzat ċentralment (HBVAXPRO u Procomvax), fir-rigward ta' l-effikaċja tat-tilqim.
English: Developing efficient and transparent procedures to allow rapid access by users to safe and effective innovative medicines and to generic and non-prescription medicines through a single European marketing authorisation.
Maltese: Tiżviluppa proċeduri effiċjenti u trasparenti biex tippermetti aċċess rapidu minn utenti għal mediċini innovattivi, siguri u effettivi u għal mediċini ġeneriċi u li għalihom m'hemmx bżonn ta' riċetta permezz ta' awtorizzazzjoni għal tqegħid fis-suq waħdanija Ewropea.
English: Faster processing of orphan designations
Maltese: Proċessar aktar mgħaġġel ta' klassifikar ta' prodotti orfni
English: In addition to initial notifications, the Agency received 2,201 notifications of a change, representing a 120% increase compared to 2005 (1,018).
Maltese: Barra n-notifiki inizjali, l-Aġenzija rċeviet 2,201 notifika għal bidla, li jirrappreżentaw żieda ta' 120% meta mqabbla ma' l-2005 (1,108).
English: These products potentially benefit some 1.6 million European patients suffering from 24 different rare conditions.
Maltese: Dawn il-prodotti potenzjalment jibbenefikaw minnhom madwar 1.6 miljun pazjent Ewropew li jsofru minn 24 kondizzjoni rari differenti.
English: Reviewing business processes to rationalise them and make them more efficient and less timeconsuming, while improving or at least maintaining the quality of the work undertaken, was emphasised in 2006 at all levels of the EMEA's operations.
Maltese: Ir-reviżjoni ta' proċessi ta' ħidma biex jiġu razzjonalizzati u biex isiru aktar effiċjenti u jaħlu inqas ħin, filwaqt li tiġi mtejba jew ta' l-inqas mantnuta l-kwalità tal-ħidma mwettqa, kienet enfasizzata fl-2006 fil-livelli kollha tal-ħidmiet ta' l-EMEA.
English: This was due to the frequent update of the Annexes to the Community marketing authorisations of parallel-distributed products and to other changes proposed by parallel distributors (e.g. addition of countries of origin).
Maltese: Dan kien minħabba l-aġġornar frekwenti ta' l-Annessi għallawtorizzazzjonijiet għal tqegħid fis-suq Komunitarji ta' prodotti mqassma b'mod parallel u għal bidliet oħrajn proposti minn distributuri paralleli (eż. żieda ta' pajjiżi ta' oriġini).
English: One of the main policy issues tackled by the CVMP during 2006 was limiting the impact on public and animal health of the development of antimicrobial resistance caused by the use of veterinary medicinal products.
Maltese: Waħda mill-kwistjonijiet ta' politika prinċipali indirizzati mis-CVMP matul l-2006 kienet kif jiġi illimitat l-impatt fuq is-saħħa pubblika u ta' l-annimali ta' l-iżvilupp tar-reżistenza antimikrobika kkaġunata bl-użu tal-prodotti mediċinali veterinarji.
English: Warnings and contra-indications were added for the classes of medicinal products (class labelling) below:
Maltese: Ġew miżjuda twissijiet u kontra-indikazzjonijiet għall-klassijiet ta' prodotti mediċinali (tikkettar ta' klassi) murija hawn taħt:
English: Finally, the EMEA was an important contributor for the development of strategic research agendas for both human and veterinary medicinal products within the 7th Framework Programme, the EU's chief instrument for funding scientific research and technological development over the period 2007 to
Maltese: Finalment, l-EMEA tat kontribut importanti għall-iżvilupp ta' aġendi ta' riċerka strateġika, kemm għall-prodotti mediċinali għallbniedem, kif ukoll għal dawk il-prodotti għall-użu fl-annimali fi ħdan is-seba' Programm ta' Qafas, listrument prinċipali ta' l-UE għall-finanzjament tar-riċerka xjentifika u l-iżvilupp teknoloġiku matul il-perjodu 2007 sa 2013.
English: The first vaccine against human papilloma virus - a widespread cause of genital infections that can lead to cervical cancer.
Maltese: L-ewwel tilqima kontra l-virus tal-papilloma tal-bniedem - kawża mifruxa ta' infezzjonijiet ġenitali li jistgħu jwasslu għal kanċer ċervikali.
English: This was the first procedure conducted under the new pharmacovigilance provision of Article 78 of Directive 2001/82/EC, as amended.
Maltese: Din kienet l-ewwel proċedura mmexxija taħt id-dispożizzjoni ġdida dwar il-farmakoviġilanza fl-Artikolu 78 tad-Direttva 2001/82/KE, kif emendata.
English: There was also a shortfall in the number of applications submitted for extension or modification of MRLs, with only 3 of the forecast 7 being submitted.
Maltese: Kien hemm ukoll nuqqas fin-numru ta' applikazzjonijiet sottomessi għall-estenzjoni jew għallmodifikazzjoni ta' l-MRLs, bi 3 biss mis-7 previsti jiġu sottomessi.
English: 2.5 Safety of medicines for human use Major safety reviews
Maltese: Sigurtà tal-mediċini għall-użu tal-bniedem Reviżjonijiet ta' sigurtà maġġuri
English: The EMEA contributed to the preparatory steps of the Innovative Medicines Initiative through its participation in workshops and frequent dialogue with the European Commission Directorate-General for Research.
Maltese: L-EMEA kkontribwixxiet għall-passi preparatorji ta' l-Inizjattiva għal Mediċini Innovattivi permezz tal-parteċipazzjoni tagħha f,workshops u djalogu frekwenti mad-Direttorat Ġenerali għar-Riċerka talKummissjoni Ewropea.
English: Areas relating to veterinary medicines included the establishment of acceptable daily intakes for the purpose of setting maximum residue limits and withdrawal periods, and efficacy of veterinary medicinal products.
Maltese: Oqsma relatati mal-mediċini veterinarji inkludew l-iffissar ta' l-ammonti li jittieħdu kuljum bil-għan li jiġu stabbiliti limiti ta' residwi massimi u perjodi ta' irtirar, u l-effikaċja tal-prodotti mediċinali veterinarji.
English: By the end of 2006, a total of 31 orphan medicinal products had been granted a centralised marketing authorisation by the European Commission since the entry into force of the European orphan medicines legislation (in 2000).
Maltese: Sa l-aħħar ta' l-2006, total ta' 31 prodott mediċinali orfni ġew mogħtija awtorizzazzjoni għal tqegħid fis-suq ċentralizzata mill-Kummissjoni Ewropea mid-dħul fis-seħħ tal-leġiżlazzjoni Ewropea talmediċini orfni (fis-sena 2000).
English: Support was provided primarily through the ad hoc GMP and GCP inspectors' meetings, which focused on harmonisation of procedures and interpretation of related requirements.
Maltese: Ġie pprovdut appoġġ, primarjament permezz tal-laqgħat ad hoc ta' l-ispetturi talGMP u tal-GCP, li ffukaw fuq l-armonizzazzjoni ta' proċeduri u l-interpretazzjoni ta' rekwiżiti relatati.
English: Products for rare forms of epilepsy in children, such as Lennox-Gastaut and Dravet's syndrome.
Maltese: Prodotti għal forom rari ta' epilesija fit-tfal, bħas-sindomi ta' Lennox-Gastaut u ta' Dravet.
English: Preparing guidance for marketing-authorisation holders and applicants on pharmacovigilance systems to put in place, and guidance for regulatory authorities on the assessment of periodic safety-update reports.
Maltese: It-tħejjija ta' gwida għad-detenturi ta' awtorizzazzjoni għal tqegħid fis-suq u l-applikanti dwar sistemi ta' farmakoviġilanza li jridu jiġu mwaqqfin, u l-gwida għal awtoritajiet regolatorji dwar ilvalutazzjoni ta' rapporti perjodiċi ta' aġġornament dwar is-sigurtà.
English: The marketing-authorisation holder and the manufacturer are currently undertaking an extensive corrective-action plan to restore GMP compliance at the site of manufacture, and the matter is under close monitoring by the CHMP.
Maltese: B'mod partikolari, sar progress kbir fl-adattament ta' rekwiżiti ta' data għal prodotti għal indikazzjonijiet minuri u speċi minuri.
English: Scientific-advice and follow-up requests Protocol-assistance and follow-up requests
Maltese: Applikazzjonijiet ta' awtorizzazzjoni ghal tqeghid fis-suq Assistenza ghal-protokoll
English: The CVMP continued to extrapolate maximum residue limits (MRLs) to further species, at the request of companies concerned.
Maltese: Is-CVMP kompliet testrapola l-limiti massimi ta' residwi (MRLs) għal speċi ulterjuri, fuq talba talkumpaniji kkonċernati.
English: The number of such procedures finalised in 2006 was also greater, with a total of 32 opinions being adopted.
Maltese: In-numru ta' tali proċeduri finalizzati fl-2006 wkoll kien akbar, b'total ta' 32 opinjoni li ġew adottati.
English: Blood
Maltese: Varji
English: The Agency is part of the Steering Council of the European Technology Platform for Global Animal Health and assisted in finalising its Strategic Research Agenda aimed at promoting access to the market for innovative products for animal health, including those for limited markets.
Maltese: L-Aġenzija hija parti mill-Kunsill ta' Tmexxija tal-Pjattaforma Teknoloġika Ewropea għas-Saħħa ta' l-Annimali fid-Dinja u assistiet fil-finalizzazzjoni ta' l-Aġenda ta' Riċerka Strateġika tagħha mmirata lejn il-promozzjoni ta' l-aċċess għas-suq għal prodotti innovattivi għas-saħħa ta' l-annimali, inkluż dawk għal swieq limitati.
English: More positive opinions were adopted in respect of anti-infectives and alimentary-tract products than other types, with those relating to the cardiovascular system forming the third major group.
Maltese: Ġew adottati aktar opinjonijiet pożittivi fir-rigward ta' prodotti anti-infettivi u tal-kanal alimentari milli tipi oħrajn, u dawk għas-sistema kardjovaskulari ifformaw it-tielet l-akbar grupp.
English: 1.2 x 1066 x 108 cells
Maltese: 1.2 x 1066 x 108 ċelluli
English: Bag (ethylene vinyl acetate)
Maltese: Borża (ethylene vinyl acetate)
English: 1-3 bags
Maltese: 1-3 boroż
English: Patient specific up to 50 ml max.
Maltese: Speċifiku għallpazjent sa massimu ta' 50 ml.
English: Dispersion for infusion
Maltese: Dispersjoni għall-infużjoni
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 21 February 2013 EMA/109958/2013 EMEA/H/C/002350
Maltese: 21 ta' Frar 2013 EMA/109958/2013 EMEA/H/C/002350
English: What is Qsiva?
Maltese: X'inhu Qsiva?
English: It was to be available as modified release capsules.
Maltese: Kellu jkun disponibbli bħala kapsuli b'rilaxx modifikat.
English: Qsiva is a medicine that contains the active substances phentermine and topiramate.
Maltese: Qsiva huwa mediċina li fiha s-sustanzi attivi phentermine u topiramate.
English: The company that applied for authorisation is Vivus BV.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Vivus BV.
English: Qsiva was expected to be used to treat severely obese patients (BMI ≥ 35 kg/m2), or patients with obesity (BMI ≥ 30 kg/m2) who have weight-related health problems, such as high blood pressure, type 2 diabetes or abnormal levels of fat in the blood.
Maltese: Qsiva kien mistenni li jintuża bħala kura għal pazjenti severament obeżi (BMI ≥ 35 kg/m2), jew pazjenti obeżi (BMI ≥ 30 kg/m2) li għandhom problemi tas-saħħa marbuta mal-piż, bħal pressjoni għolja taddemm, dijabete tat-tip 2 jew livelli mhux normali ta' xaħam fid-demm.
English: The company informed the CHMP that that there are no consequences for patients involved in clinical trials.
Maltese: Il-kumpanija informat lis-CHMP li ma hemm ebda konsegwenza għal pazjenti involuti fi provi kliniċi.
English: What was Qsiva expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Qsiva?
English: Refusal of the marketing authorisation for Qsiva (phentermine / topiramate)
Maltese: (phentermine / topiramate)
English: Phentermine suppresses appetite by releasing a chemical transmitter called norepinephrine (or noradrenaline) in the hypothalamus, the region of the brain that controls hunger.
Maltese: Phentermine jaqta' l-aptit billi jirrilaxxa trasmettitur kimiku msejjaħ norepinephrine (jew noradrenaline) fl-ipotalamu, il-parti talmoħħ li tikkontrolla l-ġuħ.
English: On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Qsiva, intended for the treatment of obesity.
Maltese: Fit-18 ta' Ottubru 2012, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Qsiva, maħsub bħala kura għall-obeżità.
English: Two of the studies specifically included patients with weight-related health problems, including diabetes, high blood pressure, and abnormal fat and sugar levels in the blood.
Maltese: Tnejn mill-istudji kienu speċifikament jinkludu pazjenti bi problemi tas-saħħa marbuta mal-piż, inkluża d-dijabete, il-pressjoni għolja tad-demm, u xaħam u livelli taz-zokkor mhux normali fid-demm.
English: The effects of Qsiva were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Qsiva għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Secondly, there were concerns about the long-term psychiatric effects (depression and anxiety were reported in the studies) and cognitive effects (such as problems with memory and attention) related to the topiramate component of Qsiva.
Maltese: It-tieni nett, kien hemm tħassib dwar l-effetti psikjatriċi fit-tul (ġew irrapportati depressjoni u ansjetà fl-istudji) u effetti konjittivi (bħal problemi bil-memorja u l-attenzjoni) marbuta mal-komponent ta' topiramate ta' Qsiva.
English: Four main studies involving a total of approximately 4,000 obese or overweight patients were conducted that compared Qsiva treatment with placebo (a dummy treatment) and with phentermine or topiramate treatments given alone.
Maltese: Saru erba' studji ewlenin li kienu jinvolvu total ta' madwar 4,000 pazjent obeżi jew li kellhom piż żejjed u li qabbel il-kura bi Qsiva ma' plaċebo (kura finta) u ma' kuri b'phentermine jew topiramate mogħtija waħedhom.
English: The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine's long-term effects on the heart and blood vessels, particularly due to the effects of phentermine, which is known to increase the heart rate but whose long-term effects are not clear.
Maltese: Il-Kumitat innota li kien hemm probabbiltà kbira li, jekk tiġi approvata, il-mediċina ma tintużax strettament għall-pazjenti maħsuba.
English: What consequences does this refusal have for patients in clinical trials?
Maltese: X'konsegwenzi għandu dan ir-rifjut għal pazjenti fi provi kliniċi?
English: EMA/434861/2014 EMEA/H/C/000917
Maltese: EMEA/H/C/000917
English: It contains the active substance filgrastim (30 or 48 million units).
Maltese: Fih issustanza attiva filgrastim (30 jew 48 miljun unità).
English: The full EPAR for Zarzio 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: The active substance in Zarzio, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF).
Maltese: Is-sustanza attiva f'Zarzio, il-filgrastim, hija simili ħafna għal proteina umana msejħa fattur stimolanti tal-kolonja granuloċiti (G CSF).
English: Other information about Zarzio
Maltese: Informazzjoni oħra dwar Zarzio
English: What is Zarzio?
Maltese: Zarzio?
English: Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce filgrastim.
Maltese: Filgrastim huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': jiġi magħmul minn batterji li fihom ikun ġie introdott ġene (DNA) li jagħmilhom kapaċi jipproduċu l-filgrastim.
English: This is a summary of the European public assessment report (EPAR) for Zarzio.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zarzio.
English: The CHMP decided that, in accordance with EU requirements, Zarzio has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Maltese: Is-CHMP iddeċieda li, b'mod konformi mar-rekwiżiti tal-UE, Zarzio wera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli ma' dak ta' Neupogen.
English: The reference medicine for Zarzio is Neupogen.
Maltese: Il-mediċina ta' referenza għal Zarzio hija Neupogen.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zarzio on 06 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Zarzio fis-06 ta' Frar 2009.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Maltese: • biex inaqqas iż-żmien ta' newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda fid-demm) u l-okkorrenza ta' newtropenija febbrili (newtropenija bid-deni) f'pazjenti li jirċievu l-kimoterapija (kura kontra l-kanċer) li hija ċitotossika (toqtol iċ-ċelloli);
English: Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Zarzio or Neupogen.
Maltese: Erba' studji ħarsu lejn il-livelli ta' newtrofili fid-demm f'total ta' 146 voluntier b'saħħithom li rċevew Zarzio jew Neupogen.
English: Zarzio was studied to show that it is comparable to the reference medicine, Neupogen.
Maltese: Zarzio ġie studjat biex jintwera li huwa komparabbli mal-mediċina ta' referenza, Neupogen.
English: Zarzio is a ‘biosimilar' medicine.
Maltese: Zarzio huwa mediċina ‘bijosimili'.
English: Why has Zarzio been approved?
Maltese: Għaliex ġie approvat Zarzio?
English: This means that Zarzio is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Maltese: Dan ifisser li Zarzio huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li tinkludi l-istess sustanza attiva (magħrufa bħala ‘mediċina ta' referenza').
English: Zarzio and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies.
Maltese: Zarzio u Neupogen ġabu żjidiet simili ta' numru ta' newtrofili fid-demm f'voluntiera b'saħħithom matul l-istudji.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar ilmediċini bijosimili, ara d-dokument mistoqsija u tweġiba hawnhekk.
English: Zarzio is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Maltese: Zarzio normalment jingħata f'ċentru ta' kura speċjalizzata, għalkemm pazjenti li jirċievuh b'injezzjoni taħt ilġilda jistgħu jinjettaw rwieħhom ladarba jitħarrġu sabiex jagħmlu dan.
English: What is the risk associated with Zarzio?
Maltese: X'inhu r-riskju assoċjat ma' Zarzio?
English: The most common side effect with Zarzio (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Maltese: L-effett sekondarju l-aktar komuni b'Zarzio (li deher f'iktar minn pazjent wieħed minn kull għaxra) hu wġiegħ muskoloskeletali (uġigħ fil-muskoli u fl-għadam).
English: How has Zarzio been studied?
Maltese: Kif ġie studjat Zarzio?
English: How does Zarzio work?
Maltese: X'inhu Zarzio?
English: For more information, see the package leaflet.
Maltese: Għal aktar informazzjoni ara lfuljett ta' tagħrif.
English: This was considered sufficient to demonstrate that the benefits of Zarzio are comparable to those of the reference medicine.
Maltese: Dan kien ikkunsidrat suffiċjenti sabiex juri li l-benefiċċji ta' Zarzio huma komparabbli ma' dawk tal-mediċina ta' referenza.
English: EMA/470505/2014 EMEA/H/C/001124
Maltese: EMEA/H/C/001124
English: The full EPAR for Temomedac 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: Temomedac is a ‘generic medicine'.
Maltese: Temomedac huwa ‘mediċina ġenerika'.
English: Temomedac temozolomide
Maltese: Temomedac temożolomur
English: Other information about Temomedac:
Maltese: Aktar informazzjoni dwar Temomedac:
English: This document is a summary of the European Public Assessment Report (EPAR) for Temomedac.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Temomedac.
English: The dose of Temomedac depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Maltese: Id-doża tat-Temomedac tiddependi mis-superfiċje tal-ġisem (ikkalkolat mit-tul u l-piż tal-pazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Maltese: • adulti u tfal minn tliet snin ‘il fuq li jbatu minn xi glijoma malinna bħall-glijoblastoma multiforme jew l-astroċitoma anaplastika, meta t-tumur tagħhom jerġa' jitfaċċa jew jiggrava wara l-kura standard.
English: The European Commission granted a marketing authorisation valid throughout the EU for Temomedac on 25 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Temomedac fil-25 ta' Jannar 2010.