FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.8): Patients with aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels).
Maltese: ● Pazjenti li għalihom żieda fil-pressjoni tad-demm jew pressjoni ġol-kranju ikollha riskju serju (ara sezzjoni 4.8): Pazjenit b'mard vaskulari ta' anewriżmu (inkluż tal-kanali tad-demm ta' ġol-kranju, talaorta toraċika jew tal-addome jew tal-kanali tad-demm periferali arterjali).
English: The time to reach maximum plasma concentration (tmax) is typically 20 to 40 minutes after the last nasal spray of a treatment session (see section 4.2).
Maltese: Il-ħin biex tintlaħaq l-ogħla konċentrazzjoni filplażma (tmax) b'mod tipiku huwa minn 20 sa 40 minuta wara l-aħħar sprej fl-imnieħer ta' sessjoni ta' trattament (ara sezzjoni 4.2).
English: Renal and urinary disorders pollakiuria, dysuria, micturition urgency
Maltese: Disturbi fil-kliewi u fissistema awrinarja pollakijurja
English: Treatment discontinuation with Spravato does not require tapering off; based on data from clinical trials the risk of withdrawal symptoms is low.
Maltese: Twaqqif tat-trattament bi Spravato ma jeħtieġx tnaqqis bil-mod il-mod; abbażi ta' data minn provi kliniċi r-riskju ta' sintomi ta' twaqqif ta' sustanza li tivvizzja huwa baxx.
English: Uncommon (PTPs) *
Maltese: Mhux komuni (PTPs)*
English: Section 4 - Possible side effects:
Maltese: Sezzjoni 4 - Effetti sekondarji possibbli
English: ”Inhibitors
Maltese: "Inibituri
English: Uncommon (PTPs)* Very common (PUPs)*
Maltese: Mhux komuni (PTPs)* Komuni ħafna (PUPs)*
English: Of the 22, 10 were high titre (≥ 5 Bethesda Units) and 12 were low titre (< 5 Bethesda Units).
Maltese: Mit-22, 10 kellhom titru għoli (≥ 5 Unitajiet Bethesda) u 12 kellhom titru baxx (< 5
English: Inhibitor Development
Maltese: Żvilipp tal-Inibitur
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, b'konformità mal-proċeduri stabbiliti f'Kapitlu 4 ta' Titolu III ta' Direttiva 2001/83/KE.
English: In the PTPT clinical trial (PTP - previously treated patients), none of the 71 subjects developed a de novo FVIII antibody, but 22 of 72 evaluable per protocol PUPs (PUP - previously untreated patients) treated with Recombinate did develop FVIII antibodies and the above frequency was based on the PUP data.
Maltese: Fl-prova klinika PTPT (PTP - pazjenti li rċivew kura fil-passat), l-ebda wieħed mill-71 individwu ma żviluppa antikorp FVIII de novo, iżda 22 mit-72 individwu evalwabbli skont il-protokoll għall-PUPs (PUP - pazjenti li qatt ma rċivew kura fil-passat) ikkurati b'Recombinate, żviluppaw antikorpi FVIII, u lfrekwenza t'hawn fuq kienet ibbażata fuq dejta mill-PUPs.
English: (Any reference to inhibitor development studies in PUPs and PTPs in section 4.8 of the SmPC should be deleted.)
Maltese: (Kwalunkwe referenza għal studji dwar l-iżvilupp ta' inibitur f'PUPs u PTPs f'sezzjoni 4.8 tal-SmPC għandha tiġi mħassra.)
English: • [[For products listed in Annex I for which a frequency for PUPs has been implemented in section 4.8 of the SmPC] the wording should be revised as follows:] “For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Maltese: • [[Għall-prodotti elenkati f'Anness I li għalihom frekwenza għal PUPs ġiet implimentata f'sezzjoni 4.8 tal-SmPC] il-kliem għandu jiġi rivedut kif ġej:] "Għal tfal li ma kinux ikkurati qabel b'mediċini li fihom Fattur VIII, antikorpiinibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod komuni ħafna (aktar minn pazjent 1 minn kull 10); madankollu, pazjenti li jkunu rċivew kura b'Fattur VIII fil-passat (aktar minn 150 jum ta' kura), ir-riskju huwa mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Annex III Amendments to the product information
Maltese: Anness III Emendi għall-informazzjoni tal-prodott
English: • [[For products listed in Annex I for which a frequency for PUPs has not been implemented in section 4.8 of the SmPC] the wording should be revised as follows:] “For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Maltese: • [[Għall-prodotti elenkati f'Anness I li għalihom frekwenza għal PUPs ma ġietx implimentata f'sezzjoni 4.8 tal-SmPC] il-kliem għandu jiġi rivedut kif ġej:] “Għal pazjenti li kienu kkurati qabel b'Fattur VIII (aktar minn 150 jum ta' kura), antikorpiinibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Section 2 - What you need to know before you <take> <use> X:
Maltese: Sezzjoni 2 - X'għandek tkun taf qabel ma <tieħu> <tuża> X:
English: Amendments to the product information
Maltese: Emendi għall-informazzjoni tal-prodott
English: The reported incidence of inhibitory antibodies in patients with severe haemophilia A who are at high risk for inhibitors development (i.e. previously untreated patients) is estimated in studies to be 31% for Recombinate, which is within the reported range for plasma derived AHF.
Maltese: L-inċidenza rrappurtata ta' antikorpi inibitorji f'pazjenti b'emofilja A li huma f'riskju għoli għall-iżvilupp tal-inibituri (i.e. pazjenti li qatt ma rċivew kura fil-passat) hi stmata fl-istudji li hi ta' 31% għal Recombinate, li hi fil-medda rrappurtata għal AHF derivat mill-plażma.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Maltese: Jekk iseħħu tali inibituri, il kundizzjoni sejra timmanifesta ruħha bħala rispons kliniku insuffiċjenti.
English: • For the remaining products (i.e. products authorised in PUPs), all existing information on inhibitor development should be replaced with the following:
Maltese: • Għall-prodotti li baqa' (i.e. prodotti awtorizzati f'PUPs), l-informazzjoni eżistenti kollha dwar liżvilupp tal-inibitur għandha tinbidel b'dan li ġej:
English: ”Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with <product name> < see section 5.1>.
Maltese: "L-iżvilupp ta' antikorpi newtralizzanti (inibituri) jista' jseħħ f'pazjenti b'emofilja A kkurati b'fattur VIII, li jinkludi b' <isem tal-prodott> <ara sezzjoni 5.1>.
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients”
Maltese: *Il-frekwenza hi bbażata fuq studji bil-prodotti kollha li fihom FVIII li kienu jinkludu pazjenti b'emofilja A severa.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Maltese: B'mod ġenerali, il-pazjenti kollha kkurati bi prodotti li fihom fattur tal-koagulazzjoni VIII għandhom ikunu sorveljati b'attenzjoni għall-iżvilupp ta' inibituri permezz ta' osservazzjonijiet kliniċi xierqa u testijiet tal-laboratorju.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Maltese: F'każijiet rari, inibituri jistgħu jiżviluppaw wara l-ewwel 100 jum tal-esponiment.
English: Section 5.1 - Pharmacodynamic properties (In accordance with the PRAC recommendation, existing relevant text in section 5.1 of the SmPC in relation to inhibitor frequency for Recombinate should be deleted.)
Maltese: (Skont ir-rakkomandazzjoni tal-PRAC, it-test rilevanti eżistenti f'sezzjoni 5.1 tal-SmPC fir-rigward talfrekwenza tal-inibitur għal Recombinate għandu jiġi mħassar.)
English: Section 4.4 - Special warnings and precautions for use
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall użu
English: B-1800 Vilvoorde
Maltese: B-1800 Vilvoorde Belgium
English: Quinta da Beloura P-2710-444 Sintra Portugal
Maltese: Quinta da Beloura P-2710-444
English: Novartis Norge AS Nydalen Alle 37A P.O Box 4284
Maltese: In-Norveġja Novartis Norge AS Nydalen Alle 37A P.O Box 4284
English: Novartis Sverige AB Kemistvägen 1B / Box 1150 SE-183 11 Täby Sweden
Maltese: Novartis Sverige AB Kemistvägen 1B / Box 1150
English: Belgium N.V. Novartis Pharma S.A. Medialaan 40, bus 1
Maltese: N.V. Novartis Pharma S.A. Medialaan 40, bus 1
English: Novartis Hungária Kft. Pharma részlege
Maltese: L-Ungerija Novartis Hungária Kft. Pharma részlege
English: Netherlands Novartis Pharma B.V. Raapopseweg 1
Maltese: Novartis Pharma B.V. Raapopseweg 1
English: H-1114 Budapest Hungary
Maltese: H-1114
English: 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
Maltese: Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France
English: Novartis Finland OY Metsänneidonkuja 10 FI-02130 Espoo Finland
Maltese: Il-Finlandja Novartis Finland OY Metsänneidonkuja 10
English: Luxembourg Novartis Pharma GmbH Roonstrasse 25
Maltese: Is-Slovenja Novartis Pharma GmbH Roonstrasse 25
English: Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria
Maltese: L-Awstrija Novartis Pharma GmbH Stella-Klein-Löw-Weg 17
English: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Maltese: Ir-Renju Unit Novartis Pharmaceuticals UK Ltd Frimley Business Park
English: 0.270 mL(833 IU/mL) 1 cartridge + 1 pack with 3 pen needles
Maltese: 0.270 mL(833 IU/mL) skartoċċ wieħed+ pakkett wieħed bi 3 labar għall-pinna
English: EU/1/09/510/016 Fertavid 150 IU/0.18 mL Solution for injection Subcutaneoususe cartridge (glass)
Maltese: EU/1/09/510/017 Fertavid 300 IU/0.
English: Kengrexal was shown to be more effective than clopidogrel taken by mouth at reducing the occurrence of these events: 4.7% of patients (257 out of 5,470 patients) given Kengrexal had an event or died compared with 5.9% (322 out of 5,469 patients) of patients given clopidogrel.
Maltese: Kengrexal intwera li huwa aktar effikaċi minn klopidogrel li jittieħed mill-ħalq fit-tnaqqis tal-okkorrenza ta' dawn l-avvenimenti: 4.7% tal-pazjenti (257 minn 5,470 pazjent) li ngħataw Kengrexal kellhom avveniment jew mietu meta mqabbel ma' 5.9% (322 minn 5,469 pazjent) tal-pazjenti li ngħataw klopidogrel.
English: This summary was last updated in 03-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 03-2015.
English: The full EPAR and risk management plan summary for Kengrexal 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: Kengrexal contains the active substance cangrelor.
Maltese: Kengrexal fih is-sustanza attiva kangrelor.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kengrexal on 23 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Kengrexal fit-23 ta' Marzu 2015.
English: Treatment starts with an injection into a vein at a dose of 30 micrograms per kilogram bodyweight, which should last less than a minute; this is followed immediately after by an infusion at a rate of 4 micrograms per kilogram each minute.
Maltese: Ilkura tinbeda b'injezzjoni fil-vina f'doża ta' 30 mikrogramma għal kull kilogramma ta' piż tal-ġisem, li għandha tieħu anqas minn minuta; din hija segwita eżattament wara minn infużjoni b'rata ta' 4 mikrogrammi għal kull kilogramma kull minuta.
English: Other information about Kengrexal
Maltese: Informazzjoni oħra dwar Kengrexal
English: This is a summary of the European public assessment report (EPAR) for Kengrexal.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kengrexal.
English: The active substance in Kengrexal, cangrelor, is an antiplatelet medicine.
Maltese: Is-sustanza attiva f'Kengrexal, kangrelor, hija mediċina kontra l-plejtlits.
English: Kengrexal was compared with clopidogrel taken by mouth in one main study involving over 11,000 adults with coronary artery disease who were undergoing PCI.
Maltese: Kengrexal tqabbel ma' clopidogrel li jittieħed mill-ħalq fi studju ewlieni wieħed li involva aktar minn 11,000 adult b'mard tal-arterji koronarji li sarilhom PCI.
English: It is used together with aspirin in adults with coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart) who are undergoing percutaneous coronary intervention (PCI - a surgical procedure used to unblock narrowed blood vessels that supply the heart).
Maltese: Jintuża flimkien mal-aspirina fl-adulti bil-mard tal-arterji koronarji (mard tal-qalb ikkawżat mill-imblokkar tal-vini li jissupplixxu l-qalb) li jkunu għaddejjin minn intervent koronarju perkutanju (PCI - proċedura kirurġika użata biex tiżblokka vini u arterji mdejqin li jissupplixxu l-qalb).
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku kangrelor
English: Kengrexal cangrelor
Maltese: Kif jintuża Kengrexal?
English: Why is Kengrexal approved?
Maltese: Għaliex ġie approvat Kengrexal?
English: Kengrexal was also investigated in one study in which it was given before surgery to patients who had been previously treated with blood-thinning medicines taken by mouth.
Maltese: Kengrexal kien investigat ukoll fi studju wieħed fejn ingħata qabel operazzjoni lil pazjenti li fil-passat kienu kkurati b'mediċini li jraqqu d-demm li jittieħdu mill-ħalq.
English: Kengrexal is given to patients who have not been treated before the procedure with other blood-thinning medicines called ‘P2Y12 inhibitors' (clopidogrel, ticagrelor or prasugrel) taken by mouth, and for whom treatment with these medicines is not possible or desirable.
Maltese: Kengrexal jingħata lil pazjenti li ma ġewx ikkurati qabel il-proċedura b'mediċini li jraqqu d-demm imsejħin "inibituri ta' P2Y12" (klopidogrel, tikagrelor jew prasugrel) li jittieħdu mill-ħalq, u li għal min kura b'dawn il-mediċini mhijiex possibbli jew rakkomandabbli.
English: The medicine has been shown to be beneficial at reducing problems caused by blood clots in patients undergoing PCI who have not received previous treatment with P2Y12 inhibitors.
Maltese: Il-mediċina ntweriet li hija ta' benefiċċju fit-tnaqqis tal-problemi kkawżati minn emboli tad-demm f'pazjenti li sarilhom PCI li ma rċevewx kura preċedenti b'inibituri ta' P2Y12.
English: What are the risks associated with Kengrexal?
Maltese: X'inhuma r-riskji assoċjati ma' Kengrexal?
English: The most common side effects with Kengrexal (which may affect up to 1 in 10 people) include mild and moderate bleeding and dyspnoea (difficulty breathing).
Maltese: L-effetti sekondarji l-aktar komuni b'Kengrexal (li jistgħu jaffettwaw sa 1 minn kull 10) jinkludu fsada ħafifa u moderata u dispnea (diffikultà fit-teħid tan-nifs).
English: Kengrexal is available as a powder to be made up into a solution for injection and infusion (drip) into a vein.
Maltese: Kengrexal jiġi bħala trab sabiex ikun magħmul soluzzjoni għal injezzjoni u infużjoni (dripp) fil-vina.
English: The most serious side effects with Kengrexal include severe and life-threatening bleeding and hypersensitivity (allergic) reactions.
Maltese: L-effetti sekondarji l-aktar serji b'Kengrexal jinkludu fsada ta' periklu għall-ħajja u reazzjonijiet (allerġiċi) ta' sensittività eċċessiva.
English: A risk management plan has been developed to ensure that Kengrexal is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Kengrexal jintuża bl-aktar mod sigur possibbli.
English: Regarding Kengrexal's safety profile, the CHMP noted that the incidence of bleeding was higher for Kengrexal than for clopidogrel, but this was expected given the greater effectiveness of the medicine, and was offset by the fact that the activity of Kengrexal wore off quickly once the infusion was stopped.
Maltese: Fir-rigward tal-profil tas-sigurtà ta' Kengrexal, is-CHMP innota li l-inċidenza ta' fsada kienet ogħla għal Kengrexal milli għal klopidogrel, iżda dan kien mistenni minħabba l-effikaċja akbar tal-mediċina, u kien ikkumpensat mill-fatt li l-attività ta' Kengrexal spiċċat malajr ladarba l-infużjoni twaqqfet.
English: For the full list of all side effects reported with Kengrexal, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Kengrexal, ara l-fuljett ta' tagħrif.
English: Kengrexal is a blood-thinning medicine used to reduce the occurrence of problems caused by blood clots, such as heart attack.
Maltese: Kengrexal huwa mediċina li traqqaq id-demm li tintuża biex titnaqqas l-okkorrenza tal-problemi kkawżati minn emboli tad-demm, bħal attakk tal-qalb.
English: 27 May 2013
Maltese: 27 ta' Mejju 2013
English: It is available as an oral suspension (20mg/5ml and 40mg/5ml).
Maltese: Jiġi f'sospensjoni orali (20mg/5ml u 40mg/5ml).
English: What is Simvastatin Vale?
Maltese: X'inhu Simvastatin Vale?
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ ir-Renju Unit) jevalwa mediċina bil-għan li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri kkonċernati', f'dan il-każ l-Awstrija, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Pajjiżi l-Baxxi, il-Portugall, Spanja u l-Isvezja kif ukoll in-Norveġja).
English: Simvastatin Vale is a medicine that contains the active substance simvastatin.
Maltese: Simvastatin Vale huwa mediċina li fiha s-sustanza attiva simvastatin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Simvastatin Vale outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li lbenefiċċji ta' Simvastatin Vale jegħlbu r-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fir-Renju Unit u fl-Istati Membri tal-UE li ġejjin: l-Awstrija, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Pajjiżi l-Baxxi, il-Portugall, Spanja u l-Isvezja kif ukoll inNorveġja.
English: On 25 March 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Simvastatin Vale.
Maltese: Fil-25 ta' Marzu 2013 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-mediċina Simvastatin Vale.
English: The bioequivalence study submitted in support of the application compared Simvastatin Vale 20mg/5ml with Zocor 20 mg tablets.
Maltese: L-istudju ta' bijoekwivalenza ppreżentat b'appoġġ tal-applikazzjoni qabbel Simvastatin Vale 20mg/5ml ma' Zocor 20 mg pilloli.
English: The active substance in Simvastatin Vale, simvastatin, belongs to a group of medicines called statins, the standard type of medicine used to reduce cholesterol.
Maltese: Is-sustanza attiva f'Simvastatin Vale, is-simvastatin, tagħmel parti minn grupp ta' mediċini msejħa statini, it-tip standard ta' mediċina użata fit-tnaqqis tal-kolesterolu.
English: Why was Simvastatin Vale reviewed?
Maltese: Għaliex ġie rivedut Simvastatin Vale?
English: Simvastatin Vale is used to treat certain forms of hypercholesterolaemia (high blood cholesterol levels) and to reduce the risk of heart disease and death in patients with atherosclerotic cardiovascular disease (where the arteries become narrower due to fatty materials building up on their inside walls) or diabetes.
Maltese: Simvastatin Vale jintuża fil-kura ta' ċerti forom ta' iperkolesterolemija (livelli għoljin ta' kolesterolu fid-demm) u biex inaqqas ir-riskju ta' mard tal-qalb u mewt f'pazjenti b'mard kardjovaskulari aterosklerotiku (fejn l-arterji jidjiequ minħabba materjal xaħmi li jakkumula fuq il-ħitan ta' ġewwa tagħhom) jew bid-dijabete.
English: Vale Pharmaceuticals Ltd submitted Simvastatin Vale to the United Kingdom's Medicines and Healthcare products Regulatory Agency for a decentralised procedure.
Maltese: Vale Pharmaceuticals Ltd ippreżenta Simvastatin Vale lill-Aġenzija Regolatorja tal-Mediċini u l-Prodotti tal-Kura tas-Saħħa tar-Renju Unit għal proċedura deċentralizzata.
English: Simvastatin Vale is a generic medicine based on a ‘reference medicine' already authorised in the EU, called Zocor.
Maltese: Simvastatin Vale huwa mediċina ġenerika bbażata fuq ‘mediċina ta' referenza' diġà awtorizzata fl-UE msejħa Zocor.
English: However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 29 January 2013.
Maltese: Madankollu l-Istati Membri ma setgħux jilħqu ftehim u r-Renju Unit irriferiet il-kwistjoni lis-CHMP għal arbitraġġ fid-29 ta' Jannar 2013.
English: The grounds for the referral were concerns about the data submitted to show that Simvastatin Vale is ‘bioequivalent' to the reference medicine, Zocor.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib dwar id-dejta ppreżentata biex turi li Simvastatin Vale huwa ‘bijoekwivalenti' għall-mediċina ta' referenza, Zocor.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data were not needed because, based on the data submitted, Simvastatin Vale is expected to produce comparable levels of the active substance in the body as the reference medicine at both strengths.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u tad-diskussjoni xjentifika li saret fil-Kumitat, is-CHMP ikkonkluda li ma kienx hemm il-ħtieġa ta' dejta addizzjonali peress li, abbażi tad-dejta ppreżentata, Simvastatin Vale mistenni jipproduċi livelli kumparabbli tas-sustanza attiva fil-ġisem bħall-mediċina ta' referenza fiż-żewġ qawwiet.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċina huma bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Finally, the CHMP also noted a clinical epidemiological study by Kovacs et al, 2002, which reported 25 cases of accidental overdoses with meprobamate.
Maltese: Finalment, is-CHMP innota wkoll studju epidemjoloġiku kliniku minn Kovacs et al, 2002, li rrapporta 25 każ ta' doża eċċessiva aċċidentali bi meprobamat.
English: Seven comas had a fatal outcome.
Maltese: Seba' komas kellhom eżitu fatali.
English: The study period was defined as 1 October 2005 to 30 September 2010.
Maltese: Il-perjodu tal-istudju kien definit bħala mill-1 ta' Ottubru 2005 sat-30 ta' Settembru 2010.
English: Meprobamate is a carbamate derivative, acting as a central nervous system depressant with anxietyrelieving, sedative and muscle relaxant activity.
Maltese: Meprobamat huwa derivattiv ta' carbamate, li jaġixxi bħala dipressant tas-sistema nervuża ċentrali b'attività sedattiva, li tagħti soljev mill-ansjetà, u rilassant għall-muskoli.