FrancophonIA/ELRC3.0 huggingface dataset:
English: Seroquel XR 50 mg contains 50 mg quetiapine (as quetiapine fumarate) Excipient : 119 mg lactose (anhydrous) per tablet Seroquel XR 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient : 71 mg lactose (anhydrous) per tablet Seroquel XR 200 mg contains 200 mg quetiapine (as quetiapine fumarate) Excipient : 50 mg lactose (anhydrous) per tablet Seroquel XR 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipient : 47 mg lactose (anhydrous) per tablet Seroquel XR 400 mg contains 400 mg quetiapine (as quetiapine fumarate) Excipient : 15 mg lactose (anhydrous) per tablet
Maltese: Il-pilloli ta' 50 mg huma kulur il-ħawħ; il-pilloli ta' 150 mg huma kulur abjad, il-pilloli ta' 200 mg huma kulur isfar; il-pilloli ta' 300 mg huma kulur isfar ċar u l-pilloli ta' 400 mg huma kulur abjad.
English: Hepato-biliary disorders
Maltese: [Biex timtela mill-pajjiż partikolari]
English: Seroquel XR dose can be adjusted depending on clinical response and tolerability of the individual patient within the dose range of 300 mg to 800 mg/day.
Maltese: tista' tiġi aġġustata skont ir-rispons kliniku u t-tollerabilità tal-pazjent individwali fil-medda tad-doża ta' 300 mg għal 800 mg/kuljum.
English: Renal Impairment
Maltese: Reazzjoni anafilattika
English: As with other antipsychotics with alpha1 adrenergic blocking activity, quetiapine may commonly induce orthostatic hypotension, associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose-titration period.
Maltese: Bħal b'antipsikotiċi oħra b'attività li timblokka l-alpha1 adrenerġiku, quetiapine jista' komunement jinduċi ipotensjoni ortostatika, assoċjata ma' sturdament, takikardja u, f'xi pazjenti, sinkope, speċjalment matul il perjodu inizjali tat-titrazzjoni tad-doża.
English: In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in bipolar disorder and major depressive disorder (see sections 4.8 and 5.1).
Maltese: Fi provi kliniċi kkontrollati bi plaċebo f'pazjenti adulti quetiapine kien assoċjat ma' żieda fl-inċidenza ta' sintomi ekstrapiramidali (EPS) meta mqabbla ma' plaċebo f'pazjenti li kienu qed jirċievu kura għal episodji depressivi maġġuri f'disturbi bipolari u f'disturbi depressiv maġġuri (ara sezzjonijiet 4.8 u
English: The safety and efficacy of doses greater than 800 mg/day have not been evaluated.
Maltese: Is-sigurtà u l-effikaċja ta' dożi akbar minn 800 mg/kuljum ma ġewx evalwati.
English: Hyperglycaemia
Maltese: L-Awstrija
English: The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients.
Maltese: Il-medja tat-tneħħija ta' quetiapine mill-plasma tnaqqset bi 30% għal 50% f'pazjenti anzjani meta mqabbla ma' pazjenti iżgħar.
English: The same precautions observed when treating patients with major depressive episodes should therefore be observed when treating patients with other psychiatric disorders.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Rhabdomyoly sis
Maltese: Ir-Renju Unit
English: Fasting blood glucose ≥126 mg/dL (≥7.0 mmol/L) or a non fasting blood glucose ≥200 mg/dL (≥11.1 mmol/L) on at least one occasion.
Maltese: Glukosju fid-demm waqt is-sawm ≥126 mg/dL(≥7.0 mmol/L) jew glukosju fid-demm mhux waqt is-sawm ≥200 mg/dL (≥11.1 mmol/L) f'mill-inqas okkażjoni waħda.
English: The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily.
Maltese: madanakollu jekk ikun hemm ġustifikazzjoni klinika d-doża tista' tiżdied għal 800 mg kuljum.
English: • Constipation, upset stomach (indigestion).
Maltese: • Stitikezza, stonku mqalleb (indiġestjoni).
English: Depression in bipolar disorder is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
Maltese: Id-dipressjoni f'disturbi bipolari hija assoċjata ma' riskju akbar ta' ħsibijiet suwiċidali, li pazjenti jweġġgħu lilhom infushom u suwiċidju (avvenimenti relatati mas-suwiċidju).
English: Quetiapine demonstrates selectivity for the limbic system by producing depolarisation blockade of the mesolimbic but not the nigrostriatal dopamine-containing neurones following chronic administration.
Maltese: Fertilità L-effetti ta' quetiapine fuq il-fertilità tal-bniedem ma ġewx ivvalutati.
English: 50 prolonged-release tablets
Maltese: TAL-PRODOTT MEDIĊINALI
English: Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
Maltese: Aktar aġġustamenti tad-doża sa 800 mg/jum sa Jum 6 għandhom ikunu b'żidiet ta' mhux aktar minn 200 mg/kuljum.
English: Possible risk factors for neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced neutropenia.
Maltese: Fatturi ta' riskju possibbli għal newtropenja jinkludu għadd baxx ta' ċelluli bojod (WBC) pre-eżistenti u storja ta' newtropenja ikkawżata mill-mediċina.
English: • Putting on weight.
Maltese: • Għandek pressjoni baxxa tad-demm.
English: Children and Adolescents Seroquel is not for use in children and adolescents below 18 years of age.
Maltese: Seroquel m'għandux jintuża minn tfal u adolexxenti taħt it-18-il sena.
English: • Rapid heartbeat.
Maltese: • Żomm dan il-fuljett.
English: Hyperglycaemia:
Maltese: F'dan il-fuljett:
English: In rats, pigment deposition in the thyroid gland has been observed; in cynomolgus monkeys thyroid follicular cell hypertrophy, a lowering in plasma T3 levels, decreased haemoglobin concentration and a decrease of red and white blood cell count have been observed; and in dogs lens opacity and cataracts.
Maltese: Fil-firien, kienet osservata depożizzjoni tal-pigment fil-glandola tat-tirojde; f'xadini cynomolgus ipertrofija taċ-ċelluli follikulari tat-tirojde, tnaqqis fil-livelli tat-T3 fil-plasma, tnaqqis fil konċentrazzjoni tal-emoglobina u tnaqqis fl-għadd taċ-ċelluli ħomor u bojod tad-demm; u fil-klieb opaċità tal-lenti u katarretti.
English: Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy.
Maltese: L-użu konkomitanti ta' quetiapine ma' indutturi qawwija ta' enzimi epatiċi bħal carbamazepine jew phenytoin inaqqas sostanzjalment il-konċentrazzjonijiet ta' quetiapine fil-plasma, li jista' jaffettwa l effikaċja tat-terapija bi quetiapine.
English: Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with the use of neuroleptics and are considered class effects.
Maltese: Każijiet ta' titwil tal-QT, arritmija ventrikulari, mewt f'daqqa mingħajr spjegazzjoni, attakk tal-qalb u torsades de pointes kienu rrapportati bl-użu ta' newrolettiċi u huma meqjusa effetti tal-klassi.
English: • Women to have no monthly period or irregular periods.
Maltese: • In-nisa ma jkollhomx pirjid fix-xahar jew pirjids irregolari.
English: The incidence of reciprocal, potentially clinically significant shifts of both T3 or T4 and TSH in these trials were rare, and the observed changes in thyroid hormone levels were not associated with clinically symptomatic hypothyroidism.
Maltese: L-inċidenza ta' tibdil reċiproku, potenzjalment klinikament sinifikanti kemm fit-T3 jew it-T4 u t-TSH f'dawn il-provi kienet rari, u l-bidliet osservati fil-livelli ta' ormoni tat-tirojde ma kienux assoċjati ma' ipotirojdiżmu klinikament sintomatiku.
English: In two recurrence prevention studies evaluating Seroquel in combination with mood stabilizers, in patients with manic, depressed or mixed mood episodes, the combination with Seroquel was superior to mood stabilizers monotherapy in increasing the time to recurrence of any mood event (manic, mixed or depressed).
Maltese: F'żewġ studji għall-prevenzjoni ta' rikorrenza li vvalutaw Seroquel f'kombinazzjoni ma' stabilizzaturi tal-burdata, f'pazjenti b'episodji manijaċi, depressivi jew burdati imħallta, il-kombinazzjoni ma' Seroquel kienet superjuri għal monoterapija bi stabilizzaturi tal-burdata biex itawlu ż-żmien għal rikorrenza ta' kwalunkwe każ relatat mal-burdata (manijaku, imħallat jew depressiv).
English: NAME OF THE MEDICINAL PRODUCT Seroquel 100 (or 150 mg, or 200 mg or 300 mg) mg film-coated tablets quetiapine
Maltese: Seroquel 100 mg (jew 150 mg, jew 200 mg jew 300 mg) pilloli miksjin b'rita quetiapine
English: • Walking, talking , eating or other activities while you are asleep.
Maltese: • Timxi, titkellem, tiekol jew tagħmel attivitajiet oħra waqt li tkun rieqed.
English: Venous thromboembolism
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled trials in the dementia population with some atypical antipsychotics.
Maltese: Fi provi randomizzati kkontrollati bi plaċebo fil-popolazzjoni b'dimenzja dehret żieda ta' madwar 3darbiet fir-riskju ta' avvenimenti ċerebrovaskulari avversi b'ċerti antipsikotiċi atipiċi.
English: Clinical trials with quetiapine have shown that in addition to the known safety profile identified in adults (see section 4.8), certain adverse events occurred at a higher frequency in children and adolescents compared to adults (increased appetite, elevations in serum prolactin, vomiting, rhinitis and syncope), or may have different implications for children and adolescents (extrapyramidal symptoms and irritability) and one was identified that has not been previously seen in adult studies (increases in blood pressure).
Maltese: Provi kliniċi bi quetiapine wrew li minbarra l-profil ta' sigurtà magħruf identifikat fl-adulti (ara sezzjoni 4.8), ċerti avveniment avversi seħħew bi frekwenza ogħla fit-tfal u l-adolexxenti meta mqabbla mal-adulti (żieda fl-aptit, żidiet tal-prolactin fisserum, rimettar, rinite u sinkope) jew jista' jkollu implikazzjonijiet differenti għat-tfal u l-adolexxenti
English: The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerability of the patient.
Maltese: Id-doża għandha tiġi aġġustata fil-medda ta' doża effettiva ta' bejn 400 mg sa 800 mg kuljum, skont ir-rispons kliniku u t-tollerabilità tal-pazjent.
English: EMA/599496/2014 EMEA/H/C/002825
Maltese: EMEA/H/C/002825
English: The full EPAR and risk management plan summary for Trulicity 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 Trulicity, dulaglutide, is a ‘GLP-1 receptor agonist'.
Maltese: Is-sustanza attiva fi Trulicity, dulaglutide, hija ‘agonista tar-riċettur GLP-1'.
English: Trulicity contains the active substance dulaglutide.
Maltese: Trulicity fih is-sustanza attiva dulaglutide.
English: Other information about Trulicity
Maltese: Informazzjoni oħra dwar Trulicity
English: Trulicity is available as prefilled pens (0.75 mg and 1.5 mg) containing a solution to be injected under the skin.
Maltese: Trulicity huwa disponibbli bħala pinen mimlijin għal-lest (0.75 mg u 1.5 mg) li fihom soluzzjoni li tiġi injettata taħt il-ġilda.
English: After 26 weeks of treatment, Trulicity reduced HbA1c by between 0.71 and 1.59 percentage points at the lower dose, and by between 0.78 and 1.64 percentage points at the higher dose.
Maltese: Wara 26 ġimgħa ta' kura, Trulicity naqqas l-HbA1c b'bejn 0.71 u 1.59 punti perċentwali fid-doża lbaxxa, u b'bejn 0.78 u 1.64 punti perċentwali fid-doża l-għolja.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom with a type of diabetes medicine called a sulphonylurea or with insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom ġimgħa flimkien ma' mediċini oħrajn kontra d-dijabete (għalkemm it-tobba jistgħu jibdew b'doża iktar baxxa f'pazjenti li huma potenzjalment f'riskju potenzjalment ikbar bħal dawk li għandhom aktar minn 75 sena).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trulicity on 21 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Trulicity fil-21 ta' Novembru 2014.
English: The benefits of Trulicity have been studied in 5 main studies involving over 4,500 patients with type 2 diabetes.
Maltese: Il-benefiċċji ta' Trulicity ġew studjati f'5 studji ewlenin li involvew aktar minn 4,500 pazjenti b'dijabete tip 2.
English: This is a summary of the European public assessment report (EPAR) for Trulicity.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Trulicity.
English: Why is Trulicity approved?
Maltese: Għaliex ġie approvat Trulicity?
English: Trulicity was more effective than metformin at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines exenatide (given twice daily) or sitagliptin, and at least as good as insulin glargine, when used as add-on to other treatments.
Maltese: Trulicity kien iktar effettiv minn metformina fit-tnaqqis tal-livelli ta' HbA1c meta użat waħdu, u kien iktar effettiv mill-mediċina tad-dijabete exenatide (mogħtija darbtejn kuljum) jew sitagliptin, u talinqas tajba daqs insulina glargine, meta użat bħala supplimentazzjoni għal kuri oħrajn.
English: What are the risks associated with Trulicity?
Maltese: X'inhuma r-riskji assoċjati ma' Trulicity?
English: This was considered to be clinically meaningful and there was evidence that the benefits were maintained during long-term treatment.
Maltese: Dan tqies bħala klinikament sinifikanti u kien hemm evidenza li l-benefiċċji nżammu waqt kura fit-tul.
English: About 51% of those given the lower dose and 60% of patients given the higher dose of Trulicity achieved a target HbA1c below 7.0% and this was generally more than the proportion achieving this target with alternative treatments.
Maltese: Madwar 51% ta' dawk li ngħataw iddoża l-baxxa u 60% tal-pazjenti li ngħataw id-doża l-għolja ta' Trulicity laħqu l-mira ta' HbA1c taħt is7.0% u dan ġeneralment kien iktar mill-proporzjon li laħqu din il-mira b'kuri alternattivi.
English: The patients' average HbA1c at baseline ranged from 7.6 to 8.5% and patients were treated for at least 52 weeks.
Maltese: Il-medja ta' HbA1c fil-linja bażi tal-pazjenti varjat minn 7.6 sa 8.5% u l-pazjenti kienu kkurati għal tal-inqas 52 ġimgħa.
English: The medicine was more effective at weekly doses of 1.5 mg than 0.75 mg.
Maltese: Il-mediċina kienet iktar effettiva f'doża ta' kull ġimgħa ta' 1.5 mg milli ta' 0.75 mg.
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Maltese: Taħdem billi teħel ma' riċetturi għal sustanza msejħa peptida simili għal glukagon (GLP-1), li jinsabu fuq il-wiċċ taċ-ċelloli fil-frixa u tistimulahom jipproduċu l-insulina.
English: With respect to safety, effects of longer term use and safety in vulnerable groups such as the very elderly would need to be monitored, but there were no specific areas of major concern and the risks were considered similar to those of other medicines in its class.
Maltese: Fir-rigward tas-sigurtà, l-effetti ta' użu fit-tul u s-sigurtà fi gruppi vulnerabbli bħall-anzjani jridu jiġu mmonitorjati, iżda ma kienx hemm oqsma speċifiċi ta' tħassib maġġri u r-riskji kienu kkunsidrati simili għal dawk ta' mediċini oħrajn fil-klassi tagħha.
English: A risk management plan has been developed to ensure that Trulicity is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Trulicity jintuża bl-aktar mod sigur possibbli.
English: Trulicity is a diabetes medicine used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Maltese: Trulicity hija mediċina tad-dijabete li tintuża f'adulti b'dijabete tip 2 biex tikkontrolla l-livell ta' glukożju (zokkor) fid-demm.
English: It can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Maltese: Tista' tintuża wkoll bħala ‘supplimentazzjoni' ma' mediċini oħrajn tad-dijabete, inkluż insulina, meta dawn il-mediċini flimkien ma' eżerċizzju u dieta ma jkunux qegħdin jipprovdu kontroll adegwat tazzokkor fid-demm.
English: What measures are being taken to ensure the safe and effective use of Trulicity?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Trulicity?
English: For further information, see the package leaflet.
Maltese: L-informazzjoni minn sitt studju li ġiet sottomessa waqt il-proċedura tqieset ukoll.
English: For practical information about using Trulicity, patients should read the package leaflet or contact their doctor or pharmacist.
Maltese: Meta Trulicity tiġi injettata, dulaglutide tasal sar-riċetturi fil-frixa u tattivahom.
English: The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni b'Trulicity (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dardir, rimettar u dijarea.
English: For the full list of all side effects and restrictions with Trulicity, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restizzjonijiet kollha bi Trulicity, ara l-fuljett ta' tagħrif.
English: The Committee noted that the medicine produces a significant and clinically relevant effect in controlling blood glucose when used with other medicines.
Maltese: Il-Kumitat innota li lmediċina tipproduċi effett sinifikanti u klinikament relevanti fuq il-kontroll taz-zokkor fid-demm meta użata ma' mediċini oħrajn.
English: Oral suspension Oral use bottle (PET)
Maltese: Suspensjoni orali flixkun (PET)
English: Content (concentration)
Maltese: Kontenut (konċentrazzjo ni)
English: 340 ml (0.5 mg/ml) 1 bottle + 2 syringes + 1 bottle adapter
Maltese: 1 flixkun + 2 siringi + 1 adapter talflixkun
English: Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: What are Alcover granules?
Maltese: X'inhuma l-granuli ta' Alcover?
English: Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC
Maltese: Riżultat ta' eżaminazzjoni mill-ġdid tal-proċedura skont l-Artikolu 29(4) tadDirettiva 2001/83/KE
English: Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)
Maltese: Mistoqsijiet u tweġibiet dwar il-granuli ta' Alcover (sodium oxybate 750, 1250 u 1750 mg)
English: (the ‘concerned Member States', in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).
Maltese: nazzjonalment kif ukoll fi Stati Membri oħra ( l-‘Istati Membri ikkonċernati', f'dan il-każ id-Danimarka, il-Finlandja, Franza, l-Irlanda, in-Netherlands, il-Polonja, il-Portugall, Spanja, l-Iżvezja u r-Renju Unit).
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni legalment vinkolanti finali applikabbli fl-Istati Membri kollha tal-UE fi 18/12/2017.
English: Why were Alcover granules reviewed?
Maltese: Għal xiex ġew riveduti l-granuli ta' Alcover?
English: The active substance in Alcover granules, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gammaaminobutyric acid (GABA), leading to a calming of the activity of these cells.
Maltese: Is-sustanza attiva fil-granuli ta' Alcover, sodium oxybate, teħel marriċetturi (fil-mira) fuq ċelloli tan-nervituri tal-moħħ u s-sinsla tad-dar għal sustanza msejħa aċidu gamma-aminobutirriku (GABA), li tikkalma l-attività ta' dawn iċ-ċelloli.
English: The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules were not clearly demonstrated and there were various risks including the risk of dependence, misuse and side effects.
Maltese: Ir-raġunijiet għar-riferiment kienu t-tħassib imqajjem minn diversi Stati Membri li l-benefiċċji talgranuli ta' Alcover ma ntwerewx b'mod ċar u kien hemm diversi riskji inkluż ir-riskju ta' dipendenza, użu ħażin u effetti sekondarji.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules did not outweigh their risks, and the marketing authorisation could not be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji tal-granuli ta' Alcover ma kinux akbar mir-riskji tagħhom, u l-awtorizzazzjoni għat-tqegħid fis-suq ma setgħetx tingħata fl-Awstrija jew fl-Istati Membri tal-UE li ġejjin: id-Danimarka, il-Finlandja, Franza, lIrlanda, in-Netherlands, il-Polonja, il-Portugall, Spbanja, l-Iżvezja u r-Renju Unit.
English: Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure.
Maltese: Debrégeas & Associés Pharma ppreżentat applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għall-granuli ta' Alcover lill-Aġenzija regolatorja tal-mediċini tal-Awstrija għal proċedura deċentralizzata.
English: On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules.
Maltese: Fit-22 ta' Ġunju 2017, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-granuli ta' Alcover.
English: Risk minimisation measures were proposed for the known risks.
Maltese: Miżuri għall-imminimizzar tar-riskju ġew proposti għar-riskji magħrufa.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules were insufficient and of inadequate quality to demonstrate that the medicine would be effective in the proposed uses.
Maltese: Abbażi tal-evalwazzjoni tad-data disponibbli attwalment u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li d-data ppreżentata b'appoġġ tal-applikazzjoni għall-awtorizzazjoni għat-tqegħid fissuq għall-granuli ta' Alcover kienet insuffiċjenti u ta' kwalità inadegwata biex turi li l-mediċina tkun effettiva fl-użijiet proposti.
English: Alcover syrup is available in Austria and Italy.
Maltese: Il-ġulepp tal-Alcover huwa disponibbli fl-Awstrija u fl-Italja.
English: After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation could not be granted.
Maltese: Wara li rreveda r-raġunijiet għal din it-talba, is-CHMP reġa' eżamina l-opinjoni u, fit-12 ta' Ottubru 2017, ikkonferma li l-awtorizzazzjoni għat-tqegħid fis-suq ma setgħetx tingħata.
English: However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija regolatorja tal-mediċini talAwstrija rreferiet il-kwistjoni lis-CHMP għal arbitraġġ fit-22 ta' Diċembru 2016.