FrancophonIA/ELRC3.0 huggingface dataset:
English: Neptra (florfenicol / terbinafine / mometasone)
Maltese: Neptra (florfenikol / terbinafina / mometason)
English: Other information about Neptra
Maltese: Informazzjoni oħra dwar Neptra
English: Further information on Neptra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/neptra.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/neptra.
English: Neptra (florfenicol / terbinafine / mometasone) EMA/560411/2019
Maltese: Neptra (florfenikol / terbinafina / mometason) EMA/687946/2019
English: Neptra received a marketing authorisation valid throughout the EU on 10 December 2019.
Maltese: Neptra ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 10/12/2019.
English: What are the risks associated with Neptra?
Maltese: X'inhuma r-riskji assoċjati ma' Neptra?
English: In a field study in Europe involving dogs with ear infections with both Staphylococcus pseudintermedius and Malassezia pachydermatitis 43 Neptra treated dogs had their signs of infection reduced by 71% after 28 days which was as effective as the comparator group of 45 dogs, treated with another veterinary medicine authorised for ear infections, for which the reduction was 74%.
Maltese: Fi studju fuq il-post fl-Ewropa li jinvolvi klieb b'infezzjonijiet fil-widnejn kemm b'Staphylococcus pseudintermedius u b'Malassezia pachydermatitis, 43 kelb ikkurati b'Neptra kellhom is-sinjali tagħhom ta' infezzjoni mnaqqsa b'71% wara 28 jum, li kien effettiv daqs il-grupp ta' paragun ta' 45 kelb li kienu kkurati b'mediċina veterinarja oħra awtorizzata għall-infezzjonijiet fil-widnejn, li għalihom it-tnaqqis kien ta' 74 %.
English: Neptra contains three active substances: florfenicol, terbinafine and mometasone.
Maltese: Nepatra fih tliet sustanzi attivi: florfenikol, terbinafina u mometason.
English: Two of the active substances in Neptra, florfenicol and terbinafine, act against possible causes of infection.
Maltese: Tnejn mis-sustanzi attivi f'Neptra, florfenikol u terbinafina, jaġixxu kontra kawżi possibbli ta' infezzjoni.
English: Florfenicol is an antibiotic which works by blocking the production of proteins, which are essential components of bacterial cell walls.
Maltese: Florfenikol hija antibijotiku li jaħdem billi jimblokka l-produzzjoni tal-proteini, li huma komponenti essenzjali tal-ħitan taċ-ċelloli batteriċi.
English: Side effects with Neptra occur very rarely, with the most often reported (which may affect up to 1 in 10,000 dogs) being whining, head shaking, nystagmus (uncontrolled eye movements), vomiting, inner ear disorders causing imbalance, loss of appetite, hyperactivity and application site pain and inflammation shortly after applying the medicine.
Maltese: L-effetti sekondarji b'Neptra jseħħu rari ħafna, bl-effetti rrapportati l-aktar ta' spiss (li jista' jaffettwa sa 1 minn kull 10,000 kelb) ikunu qrid, xengil tar-ras, nistagmus (movimenti bla kontroll tal-għajnejn), rimettar, disturbi tal-widna fuq il-parti ta' ġewwa li jikkawżaw żbilanċ, nuqqas ta' aptit, iperattività u wġigħ fil-post tal-applikazzjoni u infjammazzjoni ftit wara li tingħata l-mediċina.
English: The third active substance, mometasone, is a corticosteroid, a medicine that reduces inflammation and pain associated with the infection.
Maltese: It-tielet sustanza attiva, mometason, hija kortikosterojde, mediċina li tnaqqas l-infjammazzjoni u l-uġigħ assoċjat mal-infezzjoni.
English: This was more effective than the control group of 27 dogs, which received a placebo (dummy treatment) and for which the reduction was 49%.
Maltese: Dan kien aktar effettiv mill-grupp ta' kontroll ta' 27 kelb, li rċevew plaċebo (kura finta) u li għalihom it-tnaqqis kien ta' 49%.
English: Neptra is a veterinary medicine used to treat dogs with short lived or recurrent ear infections (otitis externa) caused by two organisms: Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast).
Maltese: Staphylococcus pseudintermedius (batterju) u Malassezia pachydermatitis (ħmira).
English: Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Maltese: Terbinafina toqtol il-fungi billi tipprevjeni l-formazzjoni ta' ergosterol, li huwa parti importanti mill-ħitan taċ-ċelloli fungali.
English: In a field study in the US involving dogs again with ear infections due to both organisms, 67 dogs treated with Neptra had a reduction in clinical score of 77% over 30 days.
Maltese: Fi studju fuq il-post fl-Istati Uniti li għal darb'oħra jinvolvi klieb b'infezzjonijiet fil-widnejn minħabba żżewġ organiżmi, 67 kelb ikkurati b'Neptra kellhom tnaqqis fil-punteġġ kliniku ta' 77% fuq perjodu ta' 30 jum.
English: It is therefore recommended that this medicine is applied only by veterinarians or under their close supervision and that measures are taken to reduce the risk (e.g. wearing safety glasses during treatment, massaging the ear canal well after application to ensure even distribution of product, restraining the dog after application).
Maltese: Għalhekk huwa rrakkomandat li din il-mediċina tiġi applikata biss mill-veterinarji jew taħt is-superviżjoni mill-qrib tagħhom u li jittieħdu miżuri biex jitnaqqas ir-riskju (eż. l-użu ta' nuċċalijiet tas-sikurezza waqt il-kura, immassaġġjar tal-kanal tal-widna ferm wara l-applikazzjoni biex tkun żgurata d-distribuzzjoni ugwali tal-prodott, trażżin tal-kelb wara lapplikazzjoni).
English: How is Neptra used?
Maltese: Kif jintuża Neptra?
English: The contents of one tube are given into each infected ear.
Maltese: Il-kontenut ta' tubu wieħed jingħata f'kull widna infettata.
English: Neptra may be harmful after swallowing.
Maltese: Neptra jista' jkun ta' ħsara wara li jinbela'.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Maltese: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
English: Polivy was investigated in a study involving 80 patients with DLBCL.
Maltese: Polivy ġie investigat fi studju li involva 80 pazjent b'DLBCL.
English: Polivy is for infusion (drip) into a vein over 90 minutes.
Maltese: Polivy jintuża għall-infużjoni (dripp) ġo vina fuq perjodu ta' 90 minuta.
English: Other information about Polivy
Maltese: Informazzjoni oħra dwar Polivy
English: The active substance in Polivy, polatuzumab vedotin, is made up of a monoclonal antibody (a type of protein) combined with a substance called monomethyl auristatin E (MMAE).
Maltese: Is-sustanza attiva f'Polivy, polatuzumab vedotin, hija magħmula minn antikorp monoklonali (tip ta' proteina) flimkien ma' sustanza msejħa monomethyl auristatin E (MMAE).
English: DLBCL is rare, and Polivy was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 April 2018.
Maltese: DLBCL hija rari, u Polivy ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis16 ta' April 2018.
English: What information is still awaited for Polivy?
Maltese: Liema informazzjoni għadha mistennija għal Polivy?
English: Polivy received a conditional marketing authorisation valid throughout the EU on 16 January 2020 Further information on Polivy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/polivy.
Maltese: ema.europa.eu/medicines/human/EPAR/polivy.
English: It is given in 21-day cycles with rituximab and bendamustine.
Maltese: Dan jingħata f'ċikli ta' 21 jum b'rituximab u bendamustine.
English: After 6 to 8 weeks of treatment, there were no signs of the cancer (complete response) in 40% of patients receiving Polivy plus rituximab and bendamustine compared with 18% of patients receiving rituximab and bendamustine alone.
Maltese: Wara 6 sa 8 ġimgħat ta' kura, ma kien hemm l-ebda sinjal tal-kanċer (rispons sħiħ) f'40 % tal-pazjenti li ngħataw Polivy u rituximab u bendamustine meta mqabbla ma' 18 % talpazjenti li ngħataw rituximab u bendamustine waħdu.
English: It is used in combination with two other medicines, bendamustine and rituximab.
Maltese: Dan jintuża flimkien ma' żewġ mediċini oħra, bendamustine u rituximab.
English: As for all medicines, data on the use of Polivy are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Polivy hija ssorveljata kontinwament.
English: Polivy (polatuzumab vedotin)
Maltese: Polivy ingħata “awtorizzazzjoni kkundizzjonata”.
English: The most common side effects with Polivy in combination with bendamustin and rituximab (which may affect more than 3 in 10 people) were anaemia (low red blood cell count), thrombocytopenia (low blood platelet count), neutropenia (low white blood cell count), tiredness, diarrhoea, nausea (feeling sick) and fever.
Maltese: L-effetti sekondarji l-aktar komuni b'Polivy flimkien ma' bendamustin u rituximab (li jistgħu jaffettwaw aktar minn 3 persuni minn kull 10) kienu anemija (għadd baxx ta' ċelloli ħomor tad-demm), tromboċitopenja (għadd baxx ta' pjastrini tad-demm), newtropenja (għadd baxx ta' ċelloli bojod tad-demm), għeja, dijarea, dardir (tħossok ma tiflaħx) u deni.
English: Polivy contains the active substance polatuzumab vedotin.
Maltese: Polivy fih is-sustanza attiva polatuzumab vedotin.
English: What are the risks associated with Polivy?
Maltese: X'inhuma r-riskji assoċjati ma' Polivy?
English: The medicine must not be given to patients who have a severe infection.
Maltese: Il-mediċina m'għandhiex tingħata lil pazjenti li għandhom infezzjoni severa.
English: Since Polivy has been given conditional authorisation, the company that markets Polivy will provide further data on its effects to confirm Polivy's safety and effectiveness when used in combination with other cancer medicines in patients with DLBCL.
Maltese: Minħabba li Polivy ingħata awtorizzazzjoni kkundizzjonata, il-kumpanija li tqiegħed Polivy fis-suq se tipprovdi aktar data dwar l-effetti tagħha biex tikkonferma s-sigurtà u l-effettività ta' Polivy meta jintuża flimkien ma' mediċini oħra kontra l-kanċer f'pazjenti b'DLBCL.
English: Patients are given paracetamol and an antihistamine medicine before receiving Polivy to reduce the risk of reactions to the infusion.
Maltese: Il-pazjenti jingħataw paracetamol u mediċina antistamina qabel ma jirċievu Polivy biex jitnaqqas irriskju ta' reazzjonijiet għall-infużjoni.
English: Serious side effects (which may affect up to 1 in 10 people) include febrile neutropenia (low white blood cell count with fever), fever, and pneumonia (infection of the lungs).
Maltese: Effetti sekondarji serji (li jistgħu jaffettwaw sa persuna 1 minn kull 10) jinkludu newtropenija bid-deni (għadd baxx ta' ċelloli bojod tad-demm bid-deni), deni, u pulmonite (infezzjoni tal-pulmun).
English: The monoclonal antibody attaches to a protein called CD79b on B cells, including cancerous B cells, and in doing so causes MMAE to be released inside them.
Maltese: CD79b fuq iċ-ċelloli B, inklużi ċ-ċelloli B kanċerużi, u meta jagħmel dan, jikkawża r-rilaxx tal-MMAE ġo fihom.
English: How is Polivy used?
Maltese: Kif jintuża Polivy?
English: Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bonemarrow transplantation.
Maltese: Polivy huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti b'linfoma taċ-ċellola B kbira diffuża (DLBCL) li l-kanċer tagħhom ikun reġa' tfaċċa jew waqaf jirrispondi għal kuri oħra u li ma jistax isirilhom trapjant tal-mudullun.
English: For the full list of side effects and restrictions of Polivy, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Polivy, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Polivy?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Polivy?
English: This summary was last updated in 03-2009.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'03-2009.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FARESTON EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) FARESTON Sommarju tal-EPAR għall-pubbliku
English: It is available as white, round tablets (60 mg).
Maltese: Huwa disponibbli bħala pilloli bojod, tondi (60 mg).
English: The marketing authorisation holder is Orion Corporation.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq hija Orion Corporation.
English: The active substance in Fareston, toremifene, is an anti-oestrogen.
Maltese: Is-sustanza attiva f'Fareston, toremifene, hija antiestroġenu.
English: Fareston is a medicine that contains the active substance toremifene.
Maltese: Fareston huwa mediċina li fiha s-sustanza attiva toremifene.
English: The effectiveness of Fareston and tamoxifen were equivalent.
Maltese: L-effikaċja ta' Fareston u tamoxifen kienu ekwivalenti.
English: Fareston must not be used in patients with ‘QT prolongation' (a disruption of the electrical activity of the heart), electrolyte disturbances (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation.
Maltese: Fareston ma għandux jintuża f'pazjenti li jbatu minn ‘prologament QT' (sfaxxar tal-attività elettrika tal-qalb), disturbi tal-elekrolite (bdil fil-livelli tal-melħ fid-demm) speċjalment ipokalemija (livelli baxxi tal-potassju), bradikardija (rata baxxa ħafna tat-taħbit tal-qalb), kollass tal-qalb (nuqqas ta' kapaċità tal-qalb li tippompja demm biżżejjed għal bqija tal-ġisem) jew storja ta' arritmiji sintomatiċi (ritmi tal-qalb mhux normali), jew f'pazjenti li jieħdu mediċini oħrajn li jikkawwżaw ukoll il-prolongament QT. Il-lista sħiħa ta' dawn ilmediċini tinsab fil-Fuljett ta' Tagħrif.
English: Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies.
Maltese: Fareston ġie studjat f'1,869 mara b'kanċer tas-sider wara l-menopawsa f'erba' studji prinċipali.
English: The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fl-14 ta' Frar 2001 u fl-14 ta' Frar 2006.
English: The effects of Fareston were compared with those of tamoxifen (another anti-oestrogen used to treat breast cancer).
Maltese: Leffetti ta' Fareston ġew imqabbla ma' dawk ta' tamoxifen (anti-estroġenu ieħor użat għat-trattament tal-kanċer tas-sider).
English: For the full list of all side effects reported with Fareston, see the Package Leaflet.
Maltese: Għal-lista kompleta tal-effetti sekondarji kollha rrappurtati b'Fareston, ara lFuljett ta' Tagħrif.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni fuq il-bażi tar-rakkomandazzjonijiet tal-CHMP, aqra d-diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Why has Fareston been approved?
Maltese: Għaliex ġie approvat Fareston?
English: The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating.
Maltese: L-aktar effetti sekondarji komuni b'Fareston (dehru f'aktar minn 1 minn kull 10 pazjenti) huma fwawar u perspirazzjoni.
English: What is Fareston?
Maltese: X'inhu Fareston?
English: How has Fareston been studied?
Maltese: Kif ġie studjat Fareston?
English: The effects of Fareston were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Fareston ġew ittestjati l-ewwel darba f'mudelli sperimentali qabel ma ġew studjati filbniedem.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours.
Maltese: Il-Kumitat dwar Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji u rriskji ta' Fareston kienu komparabbli ma' dawk ta' tamoxifen f'nisa li kellhom tumuri pożittivi għarriċetturi tal-estroġenu.
English: What is the risk associated with Fareston?
Maltese: X'inhu r-riskju assoċjat ma' Fareston?
English: Fareston is not recommended for patients with oestrogen-receptor-negative tumours (where the cancer cells do not have receptors for the hormone oestrogen on their surface).
Maltese: Fareston mhux rakkomandat għal pazjenti b'tumuri negattivi għar-riċetturi tal-estroġenu (fejn iċ-ċelloli talkanċer ma jkollhomx riċetturi għall-ormon tal-estroġenu fuq il-wiċċ tagħhom).
English: Most types of breast cancer grow in response to the hormone oestrogen.
Maltese: Ħafna tipi ta' kanċer tas-sider jikbru b'rispons għall-ormon tal-estroġenu.
English: Other information about Fareston:
Maltese: Tagħrif ieħor dwar Fareston:
English: How does Fareston work?
Maltese: X'benefiċċju wera Fareston waqt l-istudji?
English: Fareston is used to treat hormone-dependent metastatic breast cancer in women who have been through the menopause.
Maltese: Id-doża rakkomandata ta' Fareston hija pillola waħda kuljum.
English: 12 July 2012
Maltese: 12 ta' Lulju 2012
English: What is Egrifta?
Maltese: X'inhu Egrifta?
English: Egrifta is a medicine that contains the active substance tesamorelin.
Maltese: Egrifta huwa mediċina li fiha s-sustanza attiva teżamorelin.
English: The active substance in Egrifta, tesamorelin, is similar to ‘human growth hormone-releasing factor' (GRF), a hormone in the body that stimulates the release of growth hormone.
Maltese: Is-sustanza attiva f'Egrifta, it-teżamorelin, hija simili għal ‘fattur li jirrilaxxa l-ormon ta' tkabbir talbniedem' (human growth hormone-releasing factor - GRF), ormon fil-ġisem li jistimula r-rilaxx talormon ta' tkabbir.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni ppreżentata mill-kumpanija u fformula listi ta' mistoqsijiet.
English: The CHMP considered a suggestion by the company to restrict the medicine to patients with abdominal fat above a certain amount (defined as greater than 130 cm2), but the evidence supporting the cut-off point was not considered to be sufficient.
Maltese: Is-CHMP ikkunsidra suġġeriment tal-kumpanija li l-mediċina tkun ristretta għal pazjenti b'xaħam addominali ogħla minn ċertu ammont (definit bħala akbar minn 130 cm2), iżda l-evidenza li tappoġġa dak il-punt ta' distinzjoni ma kinitx meqjusa suffiċjenti.
English: On 21 June 2012, Ferrer Internacional, S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egrifta, for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Maltese: Fil-21 ta' Ġunju 2012, Ferrer Internacional, S.A. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Egrifta, li huwa prodott mediċinali li jintuża fil-kura ta' xaħam addominali żejjed fil-pazjenti bl-HIV b'lipodistrofija.
English: High levels of IGF-1 may be associated with an increased risk of cancer and a potential worsening of diabetic eye disease, and the Committee considered this to be a major safety concern.
Maltese: Livelli għoljin ta' IGF-1 jistgħu jkunu assoċjati ma' riskju akbar ta' kanċer u aggravar potenzjali ta' mard dijabetiku tal-għajnejn, u l-Kumitat ikkunsidra li dan kien tħassib ta' sigurtà importanti.
English: Withdrawal of the marketing authorisation application for Egrifta (tesamorelin)
Maltese: L-ittra tal-irtirar tinsab hawnhekk.
English: How is Egrifta expected to work?
Maltese: Għal xiex kien mistenni jintuża Egrifta?
English: What was Egrifta expected to be used for?
Maltese: Kif kien mistenni jaħdem Egrifta?
English: The studies compared Egrifta with placebo (a dummy treatment), and the main measure of effectiveness was the change in abdominal fat after 26 weeks of treatment.
Maltese: L-istudji qabblu lil Egrifta ma' plaċebo (kura finta), u lkejl ewlieni tal-effikaċja kien il-bidla fix-xaħam addominali wara 26 ġimgħa kura.
English: In terms of safety, the CHMP noted that there was an increase in the level of a protein called insulinlike growth factor 1 (IGF-1) in a considerable number of patients treated with Egrifta.
Maltese: F'dak li jirrigwarda s-sigurtà, is-CHMP innota li kien hemm żieda fil-livell ta' proteina msejħa fattur ta' tkabbir simili għall-insulina 1 (insulin-like growth factor 1 - IGF-1) f'għadd konsiderevoli ta' pazjenti kkurati b'Egrifta.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Egrifta could not have been approved for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u t-tweġibiet tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Egrifta ma setax jiġi approvat għall-kura ta' xaħam addominali żejjed fil-pazjenti bl-HIV b'lipodistrofija.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Maltese: Sa fejn kienet waslet il-valutazzjoni tal-applikazzjoni qabel ma ġiet irtirata?
English: Tesamorelin is expected to act in a similar way to GRF, causing the release of growth hormone, which is then expected to increase the breakdown of fat in HIV patients with lipodystrophy, thereby reducing excess fat in the abdomen.
Maltese: Tesamorelin kien mistenni jaġixxi b'mod simili għall-GRF, u jikkawża r-rilaxx tal-ormon tat-tkabbir, li mbagħad kien mistenni jżid it-tqassim tax-xaħam fil-pazjenti bl-HIV b'lipodistrofija, u b'hekk inaqqas ix-xaħam żejjed fl-addome.
English: Egrifta was expected to be used for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, a condition that leads to changes in the distribution of body fat.
Maltese: Egrifta kien mistenni jintuża għall-kura ta' xaħam addominali żejjed f'pazjenti infettati bl-HIV b'lipodistrofija, kundizzjoni li twassal għal bidliet fit-tqassim tax-xaħam fil-ġisem.
English: The company presented the results from two main studies involving 816 HIV patients with excessive accumulation of abdominal fat.
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija biex tappoġġa l-applikazzjoni tagħha?
English: The CHMP was concerned about how Egrifta would be used in clinical practice as it would be difficult to differentiate excess abdominal fat due to lipodystrophy from excess fat due to obesity.
Maltese: Is-CHMP kien imħasseb dwar kif Egrifta kien ser jintuża fil-prattika klinika minħabba li jkun diffiċli li wieħed jiddistingwi bejn xaħam addominali żejjed ikkawżat mil-lipodistrofija u x-xaħam żejjed ikkawżat mill-obeżità.
English: EMA/282918/2013
Maltese: EMA/414367/2013 EMEA/H/C/002522
English: The full EPAR for MACI 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: This is a summary of the European public assessment report (EPAR) for MACI.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal MACI.
English: This summary was last updated in 06-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2013.
English: matrix applied characterised autologous cultured chondrocytes
Maltese: kondroċiti awtologi kkulturati karatterizzati applikati f'matriċi
English: What are the risks associated with MACI?
Maltese: X'inhuma r-riskji assoċjati ma' MACI?