FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in animals have shown that eltrombopag is likely secreted into milk (see section 5.3); therefore a risk to the suckling child cannot be excluded.
Maltese: Studji fl-annimali wrew ħsara fuq issistema riproduttiva (ara sezzjoni 5.3). Mhux magħruf ir-riskju potenzjali fuq in-nies.
English: • decreased number of eosinophils
Maltese: • tnaqqis fl-għadd ta' eosinofili
English: Forty-two to 60% of the eltrombopag-treated patients in the RAISE study were receiving 75 mg from Day 29 to the end of treatment.
Maltese: Tnejn u erbgħin sa 60% tal-individwi kkurati b'eltrombopag fl-istudju RAISE kienu qed jirċievu 75 mg mill-Jum 29 sa tmiem il-kura.
English: • digestive system problems including frequent bowel movements, food poisoning, blood in stool
Maltese: • problemi fis-sistema diġestiva inklużi movimenti frekwenti tal-imsaren, avvelenament mill ikel, demm fl-ippurgar
English: Bone marrow reticulin formation and risk of bone marrow fibrosis
Maltese: • Bil-mod imbotta l-planġer s'isfel nett fis-siringa.
English: The full EPAR for Eklira Genuair 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 summary was last updated in 05-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 05-2017.
English: Eklira Genuair aclidinium bromide
Maltese: Eklira Genuair bromur tal-aklidinju
English: Each inhalation provides 375 micrograms of aclidinium bromide equivalent to 322 micrograms of aclidinium.
Maltese: Kull inalazzjoni tipprovdi 375 mikrogramma ta' bromur tal-aklidinju ekwivalenti għal 322 mikrogramma ta' aklidinju.
English: The active substance in Eklira Genuair, aclidinium bromide, is an antimuscarinic bronchodilator.
Maltese: Is-sustanza attiva f' Eklira Genuair, il-bromur tal-aklidinju, hija bronkodilatur antimuskariniku.
English: On average, after six months of treatment, the FEV1 in patients who used 200 and 400 micrograms Eklira Genuair increased compared with placebo by 99 ml and 128 ml respectively.
Maltese: Bħala medja, wara sitt xhur ta' kura, l-FEV1 fil-pazjenti li użaw 200 u 400 mikrogramma ta' Eklira Genuair żdied b' 99 ml u 128 ml rispettivament meta mqabbel ma' plaċebo.
English: The CHMP also noted that there were no major safety concerns with Eklira Genuair, with side effects being reversible and similar to other antimuscarinic bronchodilator medicines.
Maltese: Is-CHMP innota wkoll li ma kien hemm l-ebda tħassib serju ta' sigurtà b' Eklira Genuair, bl-effetti sekondarji jkunu riversibbli u simili għal medicini bronkodilaturi antimuskariniċi oħra.
English: The dose of 400 micrograms Eklira Genuair corresponds to an inhalation providing 322 micrograms of aclidinium.
Maltese: Id-doża ta' 400 mikrogramma ta' Eklira Genuair tikkorrispondi għal inalazzjoni li tipprovdi 322 mikrogramma ta' aklidinju.
English: Other information about Eklira Genuair
Maltese: Aktar informazzjoni dwar Eklira Genuair
English: This is a summary of the European public assessment report (EPAR) for Eklira Genuair.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Eklira Genuair.
English: Other common side effects (which may affect more than 1 patient in 100) are sinusitis (inflammation of the sinuses), cough, nausea (feeling sick) and diarrhoea.
Maltese: Effetti sekondarji komuni oħra (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 100) huma sinusite (infjammazzjoni tas-sinus), sogħla, nawżja (tħossok ma tiflaħx) u dijarea.
English: Eklira Genuair is used for maintenance (regular) treatment.
Maltese: Eklira Genuair jintuża għall-kura ta' manutenzjoni (regolari).
English: Eklira Genuair contains the active substance aclidinium bromide.
Maltese: Eklira Genuair fih is-sustanza attiva bromur tal-aklidinju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eklira Genuair on 20 July 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Eklira Genuair valida fl-Unjoni Ewropea kollha fl-20 ta' Lulju 2012.
English: The study compared two doses of Eklira Genuair (200 and 400 micrograms) inhaled twice a day with placebo.
Maltese: L-istudju qabbel żewġ dożi ta' Eklira Genuair (200 u 400 mikrogramma) inalati darbtejn kuljum ma' plaċebo.
English: What are the risks associated with Eklira Genuair?
Maltese: X' inhuma r-riskji assoċjati ma' Eklira Genuair?
English: Why is Eklira Genuair approved?
Maltese: Għaliex ġie approvat Eklira Genuair?
English: As antimuscarinic bronchodilator medicines may have an effect on the heart and blood vessels, the company will closely monitor the medicine's cardiovascular effects and will carry out a further study in patients to identify any potential risks.
Maltese: Billi mediċini bronkodilaturi antimuskariniċi jista' jkollhom effett fuq il-qalb u l-arterji u l-vini taddemm, il-kumpanija ser tissorvelja mill-qrib l-effetti kardjovaskulari tal-mediċina u ser twettaq studju ieħor f' pazjenti biex tidentifika kwalunkwe riskju potenzjali.
English: Eklira Genuair is available as an inhalation powder in a portable inhaler device.
Maltese: Eklira Genuair jiġi bħala trab għall-inalazzjoni f' inalatur portabbli.
English: A main study involving 828 patients with COPD found that Eklira Genuair was more effective than placebo (a dummy treatment) at improving how well the lungs work.
Maltese: Studju ewlieni li kien jinvolvi 828 pazjent b' COPD sab li Eklira Genuair kien iktar effettiv minn plaċebo (kura finta) għat-titjib ta' kemm jaħdmu tajjeb il-pulmuni.
English: The CHMP noted that Eklira Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year.
Maltese: Is-CHMP innota li Eklira Genuair intwera li kien effettiv fit-titjib tas-sintomi ta' COPD, u l-effetti ta' benefiċċju tiegħu jibqgħu sa sena.
English: Muscarinic receptors control the contraction of muscles and when aclidinium bromide is inhaled, it relaxes the muscles of the airways.
Maltese: Ir-riċetturi muskariniċi jikkontrollaw il-kontrazzjoni tal-muskoli u meta l-bromur tal-aklidinju jkun inalat, dan jirrilassa l muskoli tal-passaġġi tal-arja.
English: For the full list of all side effects and restrictions with Eklira Genuair, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b' Eklira Genuair, ara l-fuljett ta' tagħrif.
English: The main measure of effectiveness was how Eklira Genuair improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Maltese: Il-kejl ewlieni tal-effikaċja kien kemm Eklira Genuair tejjeb il-volumi espiratorji furzati tal-pazjenti (FEV1, il-volum massimu ta' arja li persuna tista' toħroġ f' sekonda).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tagħha fl-UE u l-kondizzjonijiet ta' użu tagħha.
English: The most common side effects with Eklira Genuair (which may affect more than 5 patients in 100) are headache and nasopharyngitis (inflammation of the nose and throat).
Maltese: L-effetti sekondarji l-aktar komuni b' Eklira Genuair (li jistgħu jaffettwaw aktar minn 5 persuni minn kull 10) huma wġigħ ta' ras u nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn).
English: Therefore, the CHMP decided that Eklira Genuair's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Eklira Genuair huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Eklira Genuair is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Eklira Genuair huwa mediċina użata biex ittaffi s-sintomi tal-marda pulmonari ostruttiva kronika (COPD- chronic obstructive pulmonary disease) fl-adulti. COPD hija marda fit-tul li fiha l-passaġġi talarja u l-boroż tal-arja ġewwa l-pulmuni ssirilhom ħsara jew jiġu mblukkati, u dan iwassal għal diffikultà fit-teħid tan-nifs.
English: It is not intended to provide practical advice on how to use Eklira Genuair.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar lużu ta' Eklira Genuair.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA European Medicines Agency, 2009.
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA European Medicines Agency, 2009.
English: ©EMEA 2009
Maltese: Jannar 2009.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PCV EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) PORCILIS PCV Sommarju tal-EPAR għall-pubbliku
English: Porcilis PCV contains mineral oil.
Maltese: Porcilis PCV fih żejt minerali.
English: It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2).
Maltese: Fih proteina (antiġene) mill-virus taċ-ċirkovirus tal-ħnieżer tat-tip 2 (PCV2).
English: Other information about Porcilis PCV:
Maltese: Informazzjoni oħra dwar Porcilis PCV:
English: Porcilis PCV is a vaccine.
Maltese: Porcilis PCV huwa vaċċin.
English: PCV2 associated infections may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Maltese: Infezzjonijiet assoċjati ma' PCV2 jistgħu jinkludu sinjali kliniċi bħal telf fil-piż jew nuqqas ta' tkabbir, tkassir tal-linfonodi, diffikultà fit-teħid tan-nifs, dijarrea, ġilda pallida u suffejra (sfurija tal-ġilda).
English: A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination.
Maltese: Żieda tranżitorja fit-temperatura tal-ġisem, li normalment ma tkunx iktar minn 1°C, tista' sseħħ sa jumejn wara l-vaċċinazzjoni.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tarrakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Porcilis PCV huma ogħla mir-riskji għall-immunizzazzjoni attiva ta' ħnieżer, ta' età aktar minn tlett ijiem, kontra PCV2, u rrakkomanda li Porcilis PCV jingħata awtorizzazzjoni għattqegħid fis-suq.
English: These studies have been performed under laboratory conditions as well as under typical farming conditions representative of different pig production systems.
Maltese: Dawn l-istudji twettqu f'kundizzjonijiet ta' laboratorju kif ukoll f'kundizzjonijiet ta' trobbija tipiċi rappreżentattivi ta' sistemi ta' produzzjoni tal-ħnieżer differenti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12/ 01/ 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq valida fl-Unjoni Ewropea kollha għal Porcilis PCV lil Intervet International BV nhar il-12/01/2009.
English: Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for 22 weeks.
Maltese: Il-protezzjoni kontra PCV2 tibda fi żmien ġimagħtejn wara l-injezzjoni u ddum applikabbli għal 22 ġimgħa.
English: What is Porcilis PCV?
Maltese: Kif jaħdem Porcilis PCV?
English: Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection.
Maltese: Porcilis PCV huwa vaċċin għal użu fil-ħnieżer, li hu disponibbli f'emulsjoni injettabbli.
English: Immediate systemic hypersensitivitylike reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment.
Maltese: Eżatt wara l-vaċċinazzjoni jistgħu jseħħu reazzjonijiet ta' ipersensittività ta' natura sistemika b'sintomi newroloġiċi minuri, bħal rogħda u/jew eċċitament, li normalment jiġu solvuti wara ftit minuti u ma jeħtiġu l-ebda trattament.
English: In pigs transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Maltese: Fil-ħnieżer, jistgħu jiżviluppaw reazzjonijiet lokalizzati u tranżitorji wara l-vaċċinazzjoni prinċipalment fil-forma ta' nefħa iebsa, sħuna u xi kultant b'uġigħ (dijametru sa 10 cm).
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jista' jinstab f'modulu 6 ta' dan l-EPAR
English: Porcine circovirus type 2 (PCV2) is known to cause a wide variety of syndromes in pigs, together known as Porcine circovirus type 2-related diseases (PCVD).
Maltese: Iċ-ċirkovirus tal-ħnieżer tat-tip 2 (PCV2) huwa magħruf li jikkawża firxa wiesgħa ta' sindromi fil-ħnieżer, flimkien magħrufin bħala mard relatat ma' ċirkovirus tal-ħnieżer tat-tip 2 (PCVD).
English: Why has Porcilis PCV been approved?
Maltese: Għaliex ġie approvat Porcilis PCV?
English: monitored included weight gain, mortality as well as faecal and nasal shedding.
Maltese: Il-kejl tal-effikaċja li ġie mmonitorjat inkluda żieda fil-piż, il-mortalità kif ukoll il-produzzjoni ta' feċi u ħmieġ nażali.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni .
English: Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur.
Maltese: Kultant, tista' sseħħ żieda fittemperatura tar-rektum sa 2.5
English: What is the risk associated with Porcilis PCV?
Maltese: X'inhu r-riskju assoċjat ma' Porcilis PCV?
English: Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection.
Maltese: Porcilis PCV jintuża biex ilaqqam ħnieżer li jkollhom età ta' tlett ijiem jew aktar kontra infezzjoni bil-PCV2.
English: How has Porcilis PCV been studied?
Maltese: Kif ġie studjat Porcilis PCV?
English: The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal's blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Maltese: Il-provi wrew li l-vaċċinazzjoni tal-ħnieżer b'Porcilis PCV tgħin biex jitnaqqas l-ammont ta' virus fid-demm tal-annimal u fit-tessuti linfojdi u biex jitnaqqas it-telf fil-piż assoċjat malinfezzjoni bil-PCV2 li sseħħ matul il-perjodu tat-tismin.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: EU/1/15/1022/001
Maltese: EU/1/15/1022/001 Unituxin mg/mL
English: EU Number
Maltese: Numru EU
English: Unituxin
Maltese: Kontenut
English: Content (concentration)
Maltese: (konċentrazzjoni)
English: Intravenous use Vial (glass)
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 3.5 mg/ml Concentrate for solution for infusion
Maltese: Konċentrat għal soluzzjoni għall-infużjoni
English: (Invented) name
Maltese: (ħġieġ)
English: Flavivirus strain YF-WN
Maltese: Flavivirus razza YF-WN
English: The studies in pregnant mares showed that 89% of the vaccinated mixed-breed mares and 95% of the vaccinated thoroughbred mares produced protective antibody levels.
Maltese: L-istudji fuq debbiet tqal urew li 89% tad-debbiet ta' razza mħallta imlaqqmin u 95% tad-debbiet puri mlaqqmin ipproduċew livelli ta' antikorpi protettivi.
English: The first involved 128 pregnant mares of mixed breeds and the second involved 41 pregnant thoroughbred mares.
Maltese: L-ewwel wieħed involva 128 debba tqila ta' razez imħallta u t-tieni involva 41 debba tqila ta' razza pura.
English: It contains a strain called Yellow Fever-West Nile (YF-WN).
Maltese: Fih ir-razza msejħa Yellow Fever-West Nile (YF-WN).
English: It is available as a suspension for injection.
Maltese: Jiġi f'sospensjoni għal injezzjoni.
English: The benefit - risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ benefiċċji-riskji jinstab fil-modulu taddiskussjoni xjentifika ta' dan l-EPAR.
English: Equilis West Nile is a veterinary vaccine that contains inactivated (killed) West Nile virus.
Maltese: Equilis West Nile huwa vaċċin veterinarju li fih il-vajrus inattivat (maqtul) tal-West Nile.
English: West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Maltese: Ilvajrus tal-West Nile huwa infezzjoni li tiġi trasmessa min-nemus u tista' tikkawża mard gravi u infezzjonijiet fatali fil-moħħ taż-żwiemel infettati.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis West Nile exceed the risks for the treatment of the approved indication and recommended that Equilis West Nile be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji ta' Equilis West Nile jisbqu r-riskji għall-kura tal-indikazzjoni approvata u għaldaqstant irrakkomanda li Equilis West Nile jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The main field study showed that vaccination with Equilis West Nile when given as recommended produced protective antibody levels in 94% of the vaccinated horses at day 42 of the study.
Maltese: L-istudju prattiku ewlieni wera li meta mogħtija kif irrakkomandat, t-tilqima b'Equilis West Nile ipproduċiet livelli ta' antikorpi protettivi f'94% taż-żwiemel imlaqqmin f'jum 42 tal-istudju.
English: A slight increase in body temperature, by up to 1.5 °C, may occur for one or two days.
Maltese: Tista' tiżviluppa żieda ħafifa fit-temperatura tal-ġisem, b'madwar 1.5
English: The measure of effectiveness in all the field studies was the number of horses which developed protective antibody levels against West Nile virus.
Maltese: Il-kejl tal-effikaċja fl-istudji prattiċi kollha kien l-għadd ta' żwiemel li żviluppaw livelli ta' antikorpi protettivi kontra l-vajrus tal-West Nile.
English: Equilis West Nile was also studied in three field studies.
Maltese: Equilis West Nile ġie studjat ukoll fi tliet studji prattiċi.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis West Nile on 6 June 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Equilis West Nile fi 06/06/2013.
English: What is the risk associated with Equilis West Nile?
Maltese: X'riskji huma assoċjati ma' Equilis West Nile?
English: The duration of protection was 12 months after primary vaccination as well as after the yearly single booster vaccination.
Maltese: It-tul tal-protezzjoni kien 12-il xahar wara t-tilqima primarja kif ukoll wara t-tilqima buwster waħdanija ta' kull sena.
English: What is Equilis West Nile?
Maltese: X'inhu Equilis West Nile?
English: What is the withdrawal period?
Maltese: X'inhu l-perjodu ta' tiżmim?
English: Equilis West Nile is used to vaccinate horses from six months of age against West Nile virus.
Maltese: Equilis West Nile jintuża fit-tilqim taż-żwiemel minn sitt xhur 'il fuq kontra l-vajrus tal-West Nile.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra marda.
English: How has Equilis West Nile been studied?
Maltese: Kif ġie studjat Equilis West Nile?
English: Equilis West Nile contains an adjuvant to enhance the immune response.
Maltese: Equilis West Nile fih aġġuvant l jtejjeb ir-rispons immunitarju.
English: The first of these involved 173 horses at least six months of age, in which vaccination with Equilis West Nile was compared with a placebo (dummy injection).
Maltese: L-ewwel wieħed minn dawn involva 173 żiemel li kellhom mill-inqas sitt xhur.
English: Other information about Equilis West Nile:
Maltese: Tagħrif ieħor dwar Equilis West Nile:
English: When Equilis West Nile is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it.
Maltese: Meta żwiemel jingħataw Equilis West Nile, issistema immunitarja tagħhom tagħraf il-vajrus li jkun hemm fil-vaċċin bħala ‘barrani' u tipproduċi antikorpi kontrih.
English: EMA/CHMP/800908/2012 EMEA/H/C/002609
Maltese: EMA/130448/2013 EMEA/H/C/002609
English: 13 December 2012
Maltese: 13 ta' Diċembru 2012
English: What is Combimarv?
Maltese: X'inhu Combimarv?
English: Combimarv is a medicine that contains the active substance human insulin.
Maltese: Combimarv hija mediċina li fiha s-sustanza attiva umana l-insulina.
English: The application was a joint application from Marvel LifeSciences for Combimarv and two other medicines (Solumarv and Isomarv medium, also developed as biosimilar medicines).
Maltese: L-applikazzjoni kienet applikazzjoni konġunta minn Marvel LifeSciences għal Combimarv u żewġ medicine oħra (Solumarv u Isomarv medium, żviluppati wkoll bħala mediċini bijosimili).
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni inizjali pprovduta millkumpanija u fassal lista ta' mistoqsijiet.
English: Combimarv was intended as a replacement insulin that is similar to the insulin made by the body.
Maltese: Combimarv kien intiż li jintuża bħala sostitut tal-insulina li hija simili għall-insulina prodotta mill-ġisem.
English: Combimarv was developed as a biosimilar medicine.
Maltese: Combimarv ġie żviluppat bħala mediċina bijosimili.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Combimarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Maltese: Fil-15 ta' Novembru 2012, Marvel LifeSciences Ltd uffiċjalment għarrfu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li jixtiequ jirtiraw l-applikazzjoni tagħhom għallawtorizzazzjoni tat-tqegħid fis-suq għal Combimarv, użat għat-trattament ta' pazjenti bid-dijabete li jeħtieġu l-insulina biex jikkontrollaw il-glukożju fid-demm.
English: Withdrawal of the marketing authorisation application for Combimarv (human insulin)
Maltese: Irtirar tal-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal Combimarv (insulina umana)
English: The insulin in Combimarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Maltese: Combimarv jiġi prodott b'metodu magħruf bħala 'teknoloġija tad-DNA rikombinanti': jiġi magħmul minn batterji li jkunu diġà rċevew ġene (DNA) li jagħmilhom kapaċi jipproduċu l-insulina.
English: What consequences does this withdrawal have for patients in clinical trials?
Maltese: X'inhuma l-konsegwenzi ta' dan l-irtirar fuq pazjenti fi provi kliniċi?