FrancophonIA/ELRC3.0 huggingface dataset:
English: During the controlled portions of pivotal Humira trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer,
Maltese: F'pazjenti li kienu diġa esposti għat-tuberkulożi u pazjenti li vvjaġġaw f'żoni ta' riskju għoli ta' tuberkulożi jew mikożji endemiċi bħal histoplasmosis, coccidioidomycosis, jew blastomycosis, ir-riskji u l-benefiċċji tat terapija b'Humira għandhom jiġu kkunsidrati qabel ma tinbeda l-kura (ara infezzjonijiet opportunistiċioħra).
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at Week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Maltese: (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lillpazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'Ġimgħa 24) ta' adalimumab fis-serum kienu 8.8 ± 6.6 μg/mL meta adalimumab ma kienx użat flimkien ma' methotrexate u 11.8 ± 4.3 μg/ meta adalimumab kien użat flimkien ma' methotrexate
English: • 2 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad, in a blister.
Maltese: • 2 syringi mimlijin għal-lest (0.4 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja kull wieħed.
English: • It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Maltese: • Huwa importanti ħafna li tgħarraf lit-tabib tiegħek jekk qatt kellek tuberkulosi, jew jekk kont f'kuntatt mill-qrib ma' xi ħadd li kellu t-tuberkolosi.
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection),
Maltese: Infezzjonijiet sistemiċi (li jinkludu sepsis, candidiasis u influwenza), infezzjonijiet intestinali (li jinkludu gastroenterite virali),
English: Humira 40 mg solution for injection in pre-filled syringe with automatic needle guard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution.
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bil-labra mgħottija awtomatika hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.4 ml.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Maltese: Tendenzi simili (mhux kollha statistikament sinifikanti) ġew osservati fl-iżgħar studju AS II doubleblind kontrollat bil-plaċebo li sar b'ordni addoċċ (IX) ta' 82 pazjent adult li jbatu b'infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis).
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
Maltese: Ġew irrapurtati wkoll xi tumuri malinni oħra, xi wħud fatali, fit-tfal, adoloxxenti, u adulti żgħar (sa 22 sena) kkurati b'xi antagonisti tat-TNF (fejn il-kura tkun inbdiet ≤ 18 il-sena), li jinkludu adalimumab wara li tqiegħed fuq is-suq.
English: Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus.
Maltese: Sintomi jistgħu jinkludu noduli ratba (nefħa) u axxessi (imsiemer fil-follikuli tax-xagħar) li jistaw inixxu materja.
English: Humira 20 mg injection adalimumab SC
Maltese: U MNEJN GĦANDU JINGĦATA Humira 20mg injezzjoni adalimumab
English: The safety and efficacy of Humira were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised doubleblind study (Psoriasis Study III).
Maltese: Is-sigurtà u l-effikaċja ta' Humira ġew studjati wkoll f'pazjenti adulti li jbatu minn Psorijasi kronika li tikkawża qoxra mhux normali fuq il-ġilda u psorijasi fl-idejn u/jew fis-saqajn fl-istess ħin li kienu kandidati għat-terapija sistemika fl-istudju double-blind magħżula b'ordni addoċċ (Studju tal-Psorijasi III).
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Maltese: 1%) pazjent ġew ikkurati flimkien ma' mediċini anti-rewmatiċi li li jaffetwaw ilproċess tal-marda, u 37 (9.4%) pazjent flimkien ma' glukokortikojdi.
English: Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Maltese: Adalimumab jeħel speċifikament mat-TNF u jinnewtralizza il-funzjoni bijoloġika tat-TNF billi jimblokka l-interazzjoni tiegħu ma'riċetturi TNF p55 u p75 fuq il-wiċċ taċ-ċellola.
English: • lichenoid skin reaction (itchy reddish-purple skin rash)
Maltese: • tibdil fil-burdata (li jinkludi depressjoni)
English: 20 mg adalimumab (if < 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.
Maltese: segwiti b'doża ta' 80 mg (bħala 2 injezzjonijiet ta' 40 mg flistess ġurnata ) ġimagħtejn wara.
English: Subjects who flared during the double-blind period were allowed Humira 40 mg eow rescue therapy for at least 12 weeks.
Maltese: Is-suġġetti li ħarġu matul il-perjodu double-blind ingħataw terapija ta' salvataġġ ta' Humira 40 mg eow għal mill-inqas 12-il ġimgħa.
English: Grey Cap 1 White Needle Sleeve White Arrow
Maltese: PAKKETT TA' BARRA, FUQ IL-PAKKETT EWLIENI
English: • 1 pre-filled pen (0.4 ml sterile solution), with 2 alcohol pads in a blister.
Maltese: • Pinna waħda mimlija għal-lest (0.4 ml soluzzjoni sterili), b'żewġ kuxxinetti bl-alkoħol f'folja.
English: Paediatric Crohn's disease Age or body weight
Maltese: Il-marda Crohn (Crohn's disease) fl-adulti u fit-tfal
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at Week 52 were 9.5±5.6g/ml for the Standard Dose group and 3.5±2.2 g/ml for the Low Dose group.
Maltese: Għall-pazjenti li baqgħu jieħdu l-kura każwali tagħhom, il-medja (±SD) tal-aktar konċentrazzjonijiet baxxi ta' adalimumab fis-serum f'Ġimgħa 52 kienet 9.5±5.6 g/ml għal grupp li qed jingħata Doża Standard u 3.5±2.2 g/ml għal grupp li qed jingħata Doża Baxxa.
English: The serum levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Maltese: Ġie osservat li l-livelli fis-serum ta' adalimumab ħieles (mhux imwaħħal ma anti-korpi ta' kontra adalimumab, AAA) kienu aktar baxxi f'pazjenti b'livelli AAA li jitkejlu.
English: Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Maltese: Mill-424 suġġett inklużi fl-estensjoni mhux ikkontrollata fit-tul tal-Istudji UV I u UV II, 60 individwu kienu meqjusa ineliġibbli (eż. minħabba devjazzjonijiet jew minħabba kumplikazzjonijiet sekondarji għal retinopatija dijabetika, minħabba kirurġija tal-katarretti jew vitrectomy) u kienu esklużi millanaliżi primarja tal-effikaċja .
English: Humira 80 mg solution for injection in pre-filled pen Each 0.8 ml single dose pre-filled pen contains 80 mg of adalimumab.
Maltese: Humira 80 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Kull pinna mimlija għal-lest b'doża waħda ta' 0.8 ml fiha 80 mg adalimumab.
English: Ulcerative colitis Ulcerative colitis is an inflammatory disease of the large intestine.
Maltese: Kolite ulċerattiva hija marda infjammatorja tal-musrana.
English: The safety and efficacy of Humira were assessed in two randomized, double-blind placebo controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Maltese: Leffikaċja u s-sigurtà ta' Humira ġew studjati f'ħames studji randomizzati,u double-blind u kontrollati ħafna.
English: of Directive 2001/83/EC.
Maltese: Direttiva 2001/83/KE.
English: November 2012.
Maltese: 12 ta' Novembru 2012.
English: • Ad-hoc expert meeting
Maltese: • Laqgħa tal-esperti ad-hoc
English: The results have shown that furosemide absorption is highly variable (AUC value varies from 793.8 to 3953 ng*h/ml, Cmax from 283,6 to 2636 ng/ml and ln Cmax values are almost a tenfold difference).
Maltese: Ir-riżultati wrew li l-assorbiment ta' furosemide huwa varjabbli ħafna (il-valur tal-AUC ivarja minn 798.8 għal 3953 ng*h/ml, is-Cmax minn 283,6 għal 2636 ng/ml u d-differenza fil-valuri ln Cmax hija ta' kważi għaxar darbiet).
English: • Clinical data
Maltese: • Dejta klinika
English: • Pharmacokinetics data
Maltese: • Dejta Farmakokinetika
English: • Pharmaceutical data
Maltese: • Dejta farmaċewtika
English: The non-clinical overview referred to 29 publications up to year 2010 describing pharmacodynamics, general pharmacology, pharmacokinetic and toxicology studies.
Maltese: Ir-rapport ġenerali mhux kliniku rrefera għal 29 pubblikazzjoni sas-sena 2010 li jiddeskrivu l-farmakodinamika, il-farmakoloġija ġenerali, il-farmakokinetika u studji tossikoloġiċi.
English: • why the safety and efficacy of the applied furosemide 40 mg product would be effectively different than in other furosemide 40 mg products
Maltese: • għaliex is-sigurtà u l-effikaċja tal-prodott furosemide 40 mg applikat sejrin ikunu effettivament differenti milli fi prodotti oħra ta' furosemide 40 mg
English: The applicant expressed its disagreement on some procedural aspects of the mutual recognition procedure, the CMDh procedure and the referral procedure under Article 29(4) of Directive 2001/83/EC.
Maltese: L-applikant esprima n-nuqqas ta' qbil tiegħu dwar ċerti aspetti proċedurali tal-proċedura ta' rikonoxximent reċiproku, il-proċedura tas-CMDh u l-proċedura ta' riferiment skont l-Artikolu 29(4) tadDirettiva 2001/83/KE.
English: • how the applied furosemide 40 mg product would cause a potential serious risk to public health
Maltese: • kif il-prodott furosemide 40 mg applikat sejjer jikkawża riskju serju potenzjali għas-saħħa pubblika
English: Indeed, furosemide is an active substance with low solubility and low permeability (BCS class IV) which does not support an extrapolation based on pharmaceutical data.
Maltese: Tabilħaqq, furosemide huwa sustanza attiva b'solubbilità baxxa u permeabiltà baxxa (klassi IV tal-BCS) li ma tappoġġjax estrapolazzjoni bbażata fuq dejta farmaċewtika.
English: The clinical part of the dossier referred to 77 publications up to 2009 supporting the effect of furosemide in the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease, including nephrotic syndrome and mild to moderate hypertension.
Maltese: Il-parti klinika tal-dossier irreferiet għal 77 pubblikazzjoni sal-2009 li jappoġġjaw l-effett ta' furosemide fil-kura ta' edima assoċjata ma' insuffiċjenza konġestiva tal-qalb, ċirrożi tal-fwied u mard tal-kliewi, inkluż is-sindromu nefrotiku u ipertensjoni ħafifa għal moderata.
English: In response to the CHMP, the applicant further referred to published pharmacokinetics data presenting PK parameters of similar tablets formulations to Furosemide Vitabalans as well as different formulations (e.g. tablet 20mg).
Maltese: Bi tweġiba għas-CHMP, l-applikant kompla jirreferi għal dejta farmakokinetika ppubblikata li tippreżenta l-parametri farmakokinetiċi ta' formulazzjonijiet simili tal-pilloli għal Furosemide Vitabalans kif ukoll għal formulazzjoni differenti (eż. pillola ta' 20mg).
English: • why the pharmacokinetics parameters of the applied furosemide 40 mg product would be different than the pharmacokinetics parameters in other furosemide products described in literature and to what extent they would be expected to be different, and how this difference would cause a concrete potential serious risk to public health.
Maltese: • għaliex il-parametri farmakokinetiċi tal-prodott furosemide 40 mg applikat sejrin ikunu differenti mill-parametri farmakokinetiċi fi prodotti oħra ta' furosemide deskritti fir-reċensjoni u sa liema punt huma mistennija li jkunu differenti, u kif din id-differenza sejra tikkawża riskju serju potenzjali konkret għas-saħħa pubblika.
English: The decentralised marketing authorisation application for Furosemide Vitabalans was made in accordance with Article 10(a) of Directive 2001/83/EC, which is a well-established use application.
Maltese: L-applikazzjoni deċentralizzata għall-awtorizzazzjoni għat-tqegħid fis-suq għal Furosemide Vitabalans kienet saret skont l-Artikolu 10(a) tad-Direttiva 2001/83/KE, li hija applikazzjoni għall-użu stabbilita sew.
English: • The Committee considered the notification of the referral triggered by Estonia under Article 29(4)
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdi mill-Estonja skont l-Artikolu 29(4) tad
English: Furosemide is a loop diuretic which acts along the entire nephron with the exception of the distal exchange site.
Maltese: Furosemide huwa dijuretiku loop li jaġixxi tul in-nephron kollu bl-eċċezzjoni tas-sit għall-iskambju distali.
English: However, it is noted that the CHMP is a scientific committee and that while it operates within the legal framework, it cannot discuss the specific merits of procedural and legal aspects of administrative procedures laid down in the legislation.
Maltese: Madankollu, ġie nnotat li s-CHMP huwa kumitat xjentifiku u li filwaqt li jopera fi ħdan il-qafas legali, ma jistax jiddiskuti l-merti speċifiċi ta' aspetti proċedurali u legali ta' proċeduri amministrattivi stabbiliti filleġiżlazzjoni.
English: The applicant also argued that dissolution behaviour together with evident pharmaceutical equivalence proves bridging between Furosemide Vitabalans and other authorised furosemide 40mg products.
Maltese: L-applikant argumenta wkoll li l-imġiba ta' dissoluzzjoni flimkien ma' ekwivalenza farmaċewtika evidenti turi rabta bejn Furosemide Vitabalans u l-prodotti l-oħra awtorizzati ta' furosemide 40mg.
English: The pharmacokinetic parameters available in the literature are not sufficient to claim that Furosemide Vitabalans would have a similar bioavailability.
Maltese: Il-parametri farmakokinetiċi disponibbli fir-reċensjoni mhumiex biżżejjed biex jiġi ddikjarat li Furosemide Vitabalans sejjer ikollu bijodisponibilità simili.
English: • The provided data do not show that Furosemide Vitabalans is similar to the products described in the submitted literature.
Maltese: • Id-dejta pprovduta ma turix li Furosemide Vitabalans huwa simili għall-prodotti deskritti fir reċensjoni sottomessa.
English: The CHMP considered that a wide range of pharmacokinetic values for different furosemide 40 mg products did not prove that the pharmacokinetic parameters of Furosemide Vitabalans will be within the same range.
Maltese: Is-CHMP ikkunsidra li firxa wiesgħa ta' valuri farmakokinetiċi għal prodotti differenti ta' furosemide 40 mg ma wrewx li l-parametri farmakokinetiċi ta' Furosemide Vitabalans sejrin ikunu flistess medda.
English: As discussed previously, in vitro data demonstrating similarity of dissolution profiles between Furosemide Vitabalans and other products containing furosemide do not prove that the bioavailability of these products would be similar, in particular, with a BCS class IV drug substance (low solubility, low permeability).
Maltese: Kif ġie diskuss qabel, dejta in vitro li turi similarità tal-profili ta' dissoluzzjoni bejn Furosemide Vitabalans u prodotti oħra li fihom furosemide ma turix li l-bijodisponibilità ta' dawn il-prodotti sejra tkun simili, b'mod partikolari, b'sustanza mediċinali tal-klassi IV tal-BCS (solubbilità baxxa u permeabiltà baxxa).
English: Furosemide has been authorised in the EU for more than 40 years.
Maltese: Furosemide ilu awtorizzat fl-UE għal aktar minn 40 sena.
English: The application for Furosemide Vitabalans is therefore based on publicly available bibliographic data as it is possible to replace results of the pre-clinical and clinical trials by detailed references to published scientific literature (information available in the public domain) if it can be demonstrated that the active substances of a medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognized efficacy and an acceptable level of safety.
Maltese: L-applikazzjoni għal Furosemide Vitabalans hija għalhekk ibbażata fuq dejta biblijografika disponibbli pubblikament peress li huwa possibbli li r-riżultati tal-provi pre-kliniċi u kliniċi jiġu sostitwiti b'referenzi dettaljati għal reċensjoni xjentifika ppubblikata (informazzjoni disponibbli fil-qasam pubbliku) jekk jista' jintwera li s-sustanzi attivi ta' prodott mediċinali ilhom f'użu mediċinali stabbilit sew fil-Komunità għal mill-inqas għaxar snin, b'effikaċja rikonoxxuta u b'livell aċċettabbli ta' sigurtà.
English: Diuretic efficacy of high dose furosemide pharmacokinetics and pharmacodynamics in health and diseasean update.
Maltese: L-Effikaċja dijuretika tal-farmakokinetika u l-farmakodinamika ta' furosemide f'doża għolja fis-saħħa u lmard - aġġornament.
English: The study in support of the safety of furosemide (Dormans et al.1) presented by the applicant, was not considered as relevant by the CHMP, as furosemide in this study was used intravenously and Furosemide Vitabalans is intended to be used in oral administration as a 40mg tablet.
Maltese: L-istudju b'appoġġ għas-sigurtà ta' furosemide (Dormans et al.1) ippreżentat millapplikant, ma kienx ikkunsidrat bħala rilevanti mis-CHMP, peress li f'dan l-istudju, furosemide intuża ġol-vina u Furosemide Viatabalans huwa maħsub biex jintuża f'għoti orali bħala pillola ta' 40mg.
English: The applicant's argument that traditional manufacturing methods as well as excipients widely used in tablet formulations would not cause potential lower or higher exposure to furosemide when Furosemide Vitabalans is used (compared to the exposure obtained following administration of other furosemide 40 mg tablets) cannot be considered as sufficient evidence to bridge the applied product and other furosemide described in the literature.
Maltese: L-argument tal-applikant li l-metodi tradizzjonali ta' manifattura kif ukoll l-eċċipjenti użati b'mod wiesa' fil-formulazzjonijiet tal-pilloli mhumiex sejrin jikkawżaw l-espożizzjoni potenzjalment aktar baxxa jew ogħla għal furosemide meta jintuża Furosemide Vitabalans (meta mqabbla mal-espożizzjoni li nkisbet wara l-għoti ta' pilloli oħra furosemide ta' 40 mg) ma jistgħux jitqiesu bħala evidenza suffiċjenti biex torbot il-prodott applikat u furosemide ieħor deskritt fir-reċensjoni.
English: The dossier submitted by the applicant did not include any in vivo clinical data which could have demonstrated that pharmacokinetic profile of Furosemide Vitabalans is similar to the products containing furosemide included in the submitted literature.
Maltese: Id-dossier sottomess mill-applikant ma kien jinkludi l-ebda dejta klinika in vivo li setgħet turi li l-profil farmakokinetiku ta' Furosemide Vitabalans huwa simili għall-prodotti li fihom furosemide inklużi firreċensjoni sottomessa.
English: During the decentralised procedure, Poland and Lithuania were of the opinion that bibliographic data on pharmacokinetics of furosemide, presented in the marketing authorisation dossier cannot be applied to Furosemide Vitabalans and should be regarded as not sufficient.
Maltese: Matul il-proċedura deċentralizzata, il-Polonja u l-Litwanja kienu tal-fehma li d-dejta biblijografika dwar il-farmakokinetika ta' furosemide, ippreżentata fid-dossier għall-awtorizzazzjoni għat-tqegħid fis-suq ma tistax tiġi applikata għal Furosemide Vitabalans u għandha titqies bħala insuffiċjenti.
English: A referral was thus triggered at the CMD(h) and the applicant was asked to justify that the literature provided in support of this application was applicable to the product applied for and to demonstrate that the potentially lower or higher exposure to furosemide, when Furosemide Vitabalans is used compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted literature, would not influence efficacy or safety.
Maltese: Għalhekk inbeda riferiment fis-CMD(h) u lapplikant intalab jiġġustifika li r-reċensjoni pprovduta b'appoġġ għal din l-applikazzjoni kienet applikabbli għall-prodott li għalih saret l-applikazzjoni u biex juri li l-espożizzjoni potenzjali aktar baxxa jew ogħla għal furosemide, meta jintuża Furosemide Vitabalans meta mqabbla mal-espożizzjoni li nkisbet wara l-għoti tal-prodott użat fl-istudji kliniċi pivotali deskritti fir-reċensjoni sottomessa, ma tinfluwenzax l-effikaċja jew is-sigurtà.
English: Overall summary of the scientific evaluation of Furosemide Vitabalans and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Furosemide Vitabalans u ismijiet assoċjati (ara Anness I)
English: Part II.1.d) of Annex I of Directive 2001/83/EC states that “the non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
Maltese: Il-Parti II.1.d) tal-Anness I għad-Direttiva 2001/83/KE tgħid li “r-reviżjonijiet mhux kliniċi u/jew kliniċi għandhom jispjegaw ir-rilevanza ta' kull data sottomessa dwar prodott differenti mill-prodott maħsub għat-tqegħid fis-suq.
English: To support the efficacy and safety of Furosemide Vitabalans, the applicant only referred to published studies.
Maltese: Biex jappoġġja l-effikaċja u s-sigurtà ta' Furosemide Vitabalans, l-applikant irrefera biss għal studji ppubblikati.
English: Following the adoption of the CHMP opinion and recommendations during the October 2012 CHMP meeting, a request for a re-examination was received from the applicant Vitabalans Oy on 12
Maltese: Wara l-adozzjoni tal-opinjoni tas-CHMP u r-rakkomandazzjonijiet magħmula matul il-laqgħa tasCHMP ta' Ottubru 2012, ġiet riċevuta talba għal eżaminazzjoni mill-ġdid mill-applikat Vitabalans Oy fit
English: As a result, procedural and legal considerations are outside the remit of the CHMP, and therefore the re-examination of the referral procedure under Article 29(4) of Directive 2001/83/EC focussed only on the scientific points addressed in the grounds for reexamination.
Maltese: B'riżultat ta' dan, kunsiderazzjonijiet proċedurali u legali huma barra mill-kompetenza tas-CHMP, u għalhekk l-eżaminazzjoni mill-ġdid tal-proċedura ta' riferiment skont l-Artikolu 29(4) tadDirettiva 2001/83/KE iffukat biss fuq il-punti xjentifiċi indirizzati fir-raġunijiet għall-eżaminazzjoni millġdid.
English: The applicant expressed its disagreement with the CHMP opinion, focusing its scientific grounds on the following points, for which the applicant argued that clear justification or evidence had not been presented to explain:
Maltese: L-applikant esprima n-nuqqas ta' qbil tiegħu mal-opinjoni tas-CHMP, u ffoka r-raġunijiet xjentifiċi tiegħu fuq il-punti li ġejjin, li dwarhom l-applikant argumenta li ma ġietx ippreżentata ġustifikazzjoni ċara jew evidenza biex jispjegaw:
English: Additional data would be needed to support the relevance of the bibliographic data to demonstrate the safety and efficacy of Furosemide Vitabalans.
Maltese: Sejjer ikun hemm il-ħtieġa ta' dejta addizzjonali biex tappoġġa rrilevanza tad-dejta biblijografika biex turi s-sigurtà u l-effikaċja ta' Furosemide Vitabalans.