FrancophonIA/ELRC3.0 huggingface dataset:
English: On some psychomotor test measures (intoxication, drunk, alertness/drowsiness, balance platform test), there was a trend towards greater effects of tasimelteon plus ethanol versus ethanol alone, but the effects were not deemed significant.
Maltese: Fuq xi kejl ta' testijiet psikomotorji (intossikazzjoni, sakra, viġilanza/ ħedla, test tal-pjattaforma tal-bilanċ), kien hemm tendenza lejn effetti akbar ta' tasimelteon flimkien mal-etanol meta mqabbel ma' etanol waħdu, iżda l-effetti ma tqisux sinifikanti.
English: Clinical Response in Non-24-Hour Sleep-Wake Disorder The effectiveness of tasimelteon in the treatment of clinical symptoms, including the circadian sleep-wake cycle and clinical global functioning in patients with Non-24 was established in SET and RESET (Table 3).
Maltese: L-effikaċja ta' tasimelteon fil-kura ta' sintomi kliniċi, inkluż iċ-ċiklu ċirkadjan ta' rqad-qawmien u l funzjonament globali kliniku f'pazjenti b'Non-24 ġie stabbilit f'SET u RESET (Tabella 3).
English: Dark blue opaque, hard capsule marked with “VANDA 20 mg” in white ink.
Maltese: Kapsula iebsa, blu skura, opaka immarkata b'"VANDA 20 mg" b'inka bajda.
English: The most frequent adverse reactions leading to discontinuation were: somnolence (0.23%), nightmare (0.23%), and headache (0.17%).
Maltese: Ir-reazzjonijiet avversi l-iktar frekwenti li wasslu għal twaqqif kienu: ngħas (0.23%), ħolm ikraħ (0.23%), u wġigħ ta' ras
English: - The shell of the capsule consists of gelatin, titanium dioxide, Brilliant Blue FCF, Erythrosine, and Orange Yellow S (E110).
Maltese: − Il-qoxra tal-kapsula tikkonsisti minn ġelatina, titanium dioxide, Brilliant Blue FCF, Erythrosine, u
English: Medicinal products that inhibit CYP1A2 and CYP3A4 have been shown to alter the metabolism of tasimelteon in vivo.
Maltese: Prodotti mediċinali li jinibixxu CYP1A2 u CYP3A4 intwerew li jibdlu lmetaboliżmu ta' tasimelteon in vivo.
English: Non-24 Scale of Clinical Response
Maltese: Tabella 2: Skala Non-24 tar-Rispons Kliniku Evalwazzjoni
English: White printing ink Shellac
Maltese: Linka bajda tal-istampar Shellac
English: HETLIOZ hard capsules contain the azo colouring agent Orange Yellow S (E110), which may cause allergic reactions.
Maltese: HETLIOZ kapsuli ibsin fihom l-aġent kolorant azo Oranġjo Isfar S (E110), li jista' jikkawża reazzjonijiet allerġiċi.
English: Response in Clinical Global Functioning Measures
Maltese: Rispons fil-Kejl tal-Funzjonament Kliniku Globali
English: HETLIOZ contains the active substance tasimelteon.
Maltese: HETLIOZ fih is-sustanza attiva tasimelteon.
English: Adverse reactions leading to discontinuation occurred in 2.3% of tasimelteon-treated patients.
Maltese: Reazzjonijiet avversi li wasslu għal twaqqif seħħew fi 2.3% tal-pazjenti kkurati b'tasimelteon.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: L-effetti fi studji mhux kliniċi kienu osservati biss f'esponimenti li kienu kkunsidrati li kienu ogħla b'mod suffiċjenti mill-esponiment massimu uman, li jindika ftit rilevanza għall-użu kliniku.
English: This includes the GABA receptor complex, the binding site for sedative hypnotics, and receptors that bind neuropeptides, cytokines, serotonin, noradrenaline, acetylcholine, and opiates.
Maltese: Dan jinkludi l-kumpless tar-riċetturi tal-GABA, is-sit tal-irbit għal ipnotiċi sedattivi, u riċetturi li jorbtu newropeptidi, ċitokini, serotonina, noradrenalina, aċetilkolina, u opjati.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' nuqqas ta' tolleranza għallgalactose, b'defiċjenza ta' Lapp lactase jew b'nuqqas ta' assorbiment ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: When administered with a high-fat meal, the Cmax of tasimelteon was 44% lower than when administered in a fasted state, and the median Tmax was delayed by approximately 1.75 hours.
Maltese: Meta mogħti ma ikla xaħmija, is-Cmax ta' tasimelteon kien 44% inqas minn meta mogħti fi stat sajjem, u tTmax medju twaħħar b'bejn wieħed u ieħor 1.75 sigħat.
English: Fertility
Maltese: Tasimelteon
English: Tasimelteon and its most abundant metabolites have no appreciable affinity for more than 160 other pharmacologically relevant receptors.
Maltese: Tasimelteon u l-metaboliti l-iktar abbundanti tiegħu m'għandhom ebda affinità apprezzabbli għal iktar minn 160 riċettur farmakoloġiku relevanti ieħor.
English: Repeated once daily dosing with tasimelteon does not result in changes in pharmacokinetic parameters or significant accumulation of tasimelteon.
Maltese: Dożaġġ ripetut ta' darba kuljum b'tasimelteon ma jirriżultax f'bidliet fil-parametri farmakokinetiċi jew f'akkumulazzjoni sinifikanti ta' tasimelteon.
English: This is deemed even more important for strong CYP1A2 inhibitors also inhibiting other enzymes involved in the clearance of HETLIOZ (e.g. fluvoxamine and ciprofloxacin).
Maltese: Dan jitqies saħansitra aktar importanti għal inibituri CYP1A2 b'saħħithom li jinibixxu wkoll enzimi oħra involuti fit tneħħija ta' HETLIOZ (eż. fluvoxamine u ciprofloxacin).
English: The Clinical Global Impression of Change (CGI-C) is a reflection of the general social, occupational, and health functioning of the patient and is evaluated on a 7-point scale, centered at No Change (4), that investigators used to rate the patients' improvement from baseline in symptoms of global functioning.
Maltese: L-Impressjoni Klinika Globali tal-Bidla (CGI-C) hija riflessjoni tal-funzjonament soċjali, okkupazzjonali, u tas-saħħa ġenerali u tiġi evalwata fuq skala b'7 punti, ċentrati fuq Ebda Bidla (4), li l-investigaturi jużaw biex jikklassifikaw it-titjib tal-pazjent mill-linja bażi fis-sintomi ta' funzjonament globali.
English: - The other ingredients are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.
Maltese: − Is-sustanzi l-oħrajn huma lactose anhydrous, microcrystalline cellulose, croscarmellose sodium,
English: Assessment
Maltese: LISTA
English: Contains lactose and Orange Yellow S (E110).
Maltese: Orange Yellow S (E110).
English: During RESET, patient diaries were recorded for an average of 57 days during the run-in phase and 59 days during the randomised-withdrawal phase.
Maltese: Waqt RESET, id-djarji tal-pazjenti nżammu għal medja ta' 57 jum matul il fażi preklinika u għal 59 jum matul il-fażi ta' rtirar randomizzata.
English: Daytime sleep on 25% most symptomatic days
Maltese: Ħin ta rqad matul il-ġurnata f'25% tal-ġranet liktar sintomatiċi.
English: The most common adverse reactions (>3%) during clinical trials were headache (10.4%), somnolence (8.6%), nausea (4.0%), and dizziness (3.1%).
Maltese: dardir (4.0%), u sturdament (3.1%).
English: Smokers (smoking is a moderate CYP1A2 inducer) Tasimelteon exposure decreased by approximately 40% in smokers, compared to non-smokers (see section
Maltese: Tipjip (induttur tas-CYP1A2 moderat) L-esponiment ta' tasimelteon tnaqqas b'bejn wieħed u ieħor 40% f'persuni li jpejpu meta mqabbel ma'
English: The body controls these rhythms through many pathways including increases and decreases in the production of the hormone melatonin.
Maltese: Il-ġisem jikkontrolla dawn ir-ritmi permezz ta' diversi metodi inklużi żidiet u tnaqqis fil-produzzjoni tal-ormon melanina.
English: Metabolism of tasimelteon consists primarily of oxidation at multiple sites and oxidative dealkylation resulting in opening of the dihydrofuran ring followed by further oxidation to give a carboxylic acid.
Maltese: Il-metaboliżu ta' tasimelteon jikkonsisti primarjament minn ossidazzjoni f'diversi postijiet u dealkalizazzjoni ossidattiva li jirriżultaw fil-ftuħ taċ-ċirku tad-dihydrofuran segwit minn iktar ossidazzjoni biex jagħti aċidu karbossiliku.
English: Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment.
Maltese: Tasimelteon ma ġiex studjat f'pazjenti b'indeboliment tal-fwied sever (Child-Pugh Klassi Ċ); għalhekk huwa rrakkomandat li tingħata attenzjoni meta jiġi preskritt HETLIOZ lil pazjenti b'indeboliment tal-fwied sever.
English: Because symptoms of nighttime sleep disruption and daytime sleepiness are cyclical in patients with Non-24, with severity varying according to the state of alignment of the individual patient's circadian rhythm with the 24-hour day (least severe when fully aligned, most severe when 12 hours out of alignment), efficacy endpoints for nighttime total sleep time and daytime nap duration were based on the 25% of nights with the least nighttime sleep, and the 25% of days with the most daytime nap time.
Maltese: Minħabba li s-sintomi ta' disturbi fil-ħin tal-irqad ta' matul il-lejl u ngħas ta' matul il-ġurnata huma ċikliċi f'pazjenti b'Non-24, b'severità li tvarja skont l-istat ta' alinjament tar-ritmu ċirkadjan tal-pazjent individwu b'ġurnata ta' 24 siegħa (l-inqas sever meta alinjat kompletament, l-iktar sever meta 12-il siegħa barra millalinjament), punti fil-mira tal-effikaċja għall-ħin totali tal-irqad matul il-lejl u t-tul tal-irqad matul il-ġurnata kienu bbażati fuq il-25% tal-iljieli bl-inqas ħin ta' rqad, u 25% tal-ġranet bl-iktar ħin ta' rqad.
English: No evidence of carcinogenic potential was observed in mice; the highest dose tested is approximately 75 times the RHD of 20 mg/day, on a mg/m2 basis.
Maltese: Ebda evidenza ta' potenzjal karċinoġeniku ma ġiet osservata fil-ġrieden; l-ogħla doża ttestjata hija bejn wieħed u ieħor 75 darba l-RHD ta' 20 mg/ġurnata, fuq bażi ta' mg/m2.
English: The following are adverse reactions that were reported in tasimelteon-treated adult patients, derived from patient trials in 1772 patients treated with tasimelteon.
Maltese: Li ġejjin huma reazzjonijiet avversi li ġew rappurtati f'pazjenti adulti kkurati b'tasimelteon, derivati minn provi tal-pazjenti f'1772 pazjenti kkurati b'tasimelteon.
English: Effects of Tasimelteon 20 mg Treatment on Clinical Response in Non-24 Tasimelteon 20 mg Placebo
Maltese: Tabella 3: L-effetti ta' Kura bi 20 mg ta' Tasimelteon fuq ir-Rispons Kliniku f'Non-24
English: Major metabolites had 13-fold or less activity at melatonin receptors compared to tasimelteon.
Maltese: Metaboliti ewlenin kellhom attività 13-il darba jew inqas fir-riċetturi tal-melatonina meta mqabbel ma' tasimelteon
English: This type of medicine is called a “melatonin agonist” that acts as a regulator of daily body rhythms.
Maltese: Din it-tip ta' mediċina hija msejħa “agonista tal-melatonina” li taġixxi bħala regolatur tar-ritmi ta' kuljum tal-ġisem.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Data mhux klinika bbażata fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma turi l-ebda periklu speċjali għall-bnedmin.
English: Tasimelteon This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: This includes: - medicines known to reduce the activity of an enzyme called ‘CYP1A2'.
Maltese: - mediċini magħrufin li jnaqqsu l-attività ta' enzima msejħa ‘CYP1A2'.
English: HETLIOZ contains Orange Yellow S (E110) which may cause allergic reactions.
Maltese: HETLIOZ fih Oranġjo Isfar S (E110) li jista' jikkawża reazzjonijiet allerġiċi.
English: Each hard capsule contains 20 mg of tasimelteon.
Maltese: Kull kapsula iebsa fiha 20 mg ta' tasimelteon.
English: SET and RESET assessed entrainment of the master body clock as measured by aMT6s and cortisol.
Maltese: SET u RESET evalwaw ir-regolament tal-arloġġ ewlieni tal-ġisem kif imkejjel minn aMT6s u kortisol.
English: HETLIOZ has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment.
Maltese: HETLIOZ ma ġiex studjat f'pazjenti b'indeboliment tal-fwied sever (Child-Pugh Klassi Ċ); għalhekk hija rakkomandata attenzjoni meta HETLIOZ jiġi preskritt lil pazjenti b'indeboliment tal-fwied sever.
English: Entrainment plus a score ≥3 on this scale, called Non-24 Clinical Response Scale (N24CRS) was required to be classified as a clinical responder.
Maltese: (N24CRS) kienet meħtieġa biex tiġi kklassifikata bħala risponditur kliniku.
English: In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofoetal mortality, neurobehavioural impairment, and decreased growth and development in offspring) at doses greater than those used clinically.
Maltese: Fl-istudji fl-annimali, l-għoti ta' tasimelteon waqt it-tqala rriżulta f'tossiċità taż-żvilupp (mortalità embrijufetali, indeboliment newrokomportattiv, u tkabbir u żvilupp imnaqqas fil-frieħ) f'dożi ikbar minn dawk klinikament użati.
English: The active substance in HETLIOZ, tasimelteon, is able to act as a time-keeper for the body rhythms and resets them each day.
Maltese: Is-sustanza attiva f'HETLIOZ, tasimelteon, kapaċi jaġixxi bħala detentur taż-żmien għar-ritmi tal-ġisem u jibdihom mill-ġdid kuljum.
English: In SET, tasimelteon entrained circadian rhythms at month 1 at a significantly higher rate than placebo as measured by aMT6s and cortisol (20% vs. 2.6 % and 17.5% vs 2.6% respectively).
Maltese: F'SET, fl-1 xahar tasimelteon irregola r-ritmi ċirkadjani b'rata ogħla b'mod sinifikanti mill-plaċebo kif imkejjel minn aMT6s u kortisol (20% vs.
English: Contents of the pack and other information What HETLIOZ contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih HETLIOZ
English: The apparent oral volume of distribution at steady state of tasimelteon in young healthy subjects is approximately 59 - 126 L. At therapeutic concentrations, tasimelteon is about 88.6 - 90.1% bound to proteins.
Maltese: F'konċentrazzjonijet terapewtiċi, tasimelteon huwa bejn wieħed u ieħor 88.6
English: Caution should be used when administering HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors, particularly those which also inhibit other enzymes involved in the clearance of HETLIOZ because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions (see section 4.5).
Maltese: Għandha tingħata attenzjoni meta jingħata HETLIOZ flimkien ma' rifampin jew indutturi CYP3A4 oħrajn minħabba tnaqqis potenzjalment kbir fl-esponiment ta' tasimelteon b'effikaċja mnaqqsa (ara sezzjoni 4.5).
English: The components of the scale can be found in Table 2.
Maltese: Il-komponenti tal-iskala jistgħu jinstabu f'tabella 2.
English: How to store HETLIOZ
Maltese: Kif jaħdem HETLIOZ
English: In pregnant rats administered tasimelteon during the period of organogenesis, there were no effects on embryofoetal development.
Maltese: Fil-firien tqal li ngħataw tasimelteon waqt il-perjodu ta' organoġenesi, ma kien hemm ebda effett fuq liżvilupp embrijufetali.
English: Uncommon: may affect up to 1 in 100 people - abnormal or change in taste - blood tests which show changes in the way the liver is working (aspartate aminotransferase and gamma-glutamyl transferase) - increase in daytime urination - nightmares - ringing in the ears - feeling foggy in the head
Maltese: - bidla jew anormalità fit-tegħim - testijiet tad-demm li juru tibdil fil-mod ta' kif qiegħed jaħdem il-fwied (aspartate aminotransferase u gamma-glutamyl transferase) - żieda fl-awrina matul il-ġurnata
English: Nighttime sleep on 25% most symptomatic nights (minutes)(3)
Maltese: Studju RESET Ħin ta' rqad matul il-lejl f'25% tal-iljieli l iktar sintomatiċi (minuti)(3)
English: Patients with Non-24 who are totally blind cannot see light, so their body rhythms shift out of alignment with the 24-hour world, resulting in periods of feeling sleepy during the day and the inability to sleep at night.
Maltese: Pazjenti b'Non-24 li huma kompletament għomja ma jistgħux jaraw id-dawl, għalhekk ir-ritmi tal-ġisem tagħhom joħorġu mill-alinjament bid-dinja t'24 siegħa, li jwassal għal perjodi fejn iħossuhom bi ngħas matul il-ġurnata u ma jkunux jistgħu jorqdu matul il-lejl.
English: The effectiveness of tasimelteon to improve clinical global functioning was evaluated in SET.
Maltese: L-effikaċja ta' tasimelteon biex itejjeb il-funzjonament kliniku globali ġiet evalwata f'SET.
English: What you need to know before you take HETLIOZ 3.
Maltese: X'għandek tkun taf qabel ma tieħu HETLIOZ 3.
English: The pharmacokinetics of tasimelteon and its metabolites did not change with repeated daily dosing.
Maltese: Il-farmakokinetiċi ta' tasimelteon u l-metaboliti tiegħu ma nbidlux b'dożaġġ ripetut ta' kuljum.
English: Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Maltese: Indeboliment tal-kliewi Ma huwa rrakkomandat ebda aġġustament tad-doża għal pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: Oral administration of tasimelteon to rats throughout organogenesis and lactation resulted in persistent reductions in body weight, delayed sexual maturation and physical development, neurobehavioural impairment in offspring at the highest dose tested, andreduced body weight in offspring at the mid-dose tested.
Maltese: Amministrazzjoni orali ta' tasimelteon lill-firien matul l-organoġenesi u treddigħ irriżultat fi tnaqqis persistenti fil-piż tal-ġisem, maturazzjoni sesswali u żvilupp fiżiku mwaħħra, indeboliment newrokomportattiv fi frieħ fl-ogħla doża ttestjata, u tnaqqis fil-piż tal-ġisem fil-frieħ ittestjati b'nofs id-doża.
English: Clinical Global Functioning in Non-24 Patients Tasimelteon 20 mg
Maltese: Tabella 4: Funzjonament Kliniku Globali f'Pazjenti Non-24
English: Tasimelteon functions as a DMRA at the MT1 and MT2 receptors.
Maltese: Tasimelteon jaġixxi bħala Dual Melatonin Receptor
English: The master body clock regulates the circadian rhythms of hormones including melatonin and cortisol and aligns/synchronises the physiological processes of the sleep-wake cycle and metabolic and cardiovascular homeostasis.
Maltese: L-arloġġ ewlieni tal-ġisem jirregola r-ritmi ċirkadjani tal-ormoni inklużi l-melatonina u l-kortisol u jallinja/jissinkronizza l-proċessi fiżjoloġiċi taċ-ċiklu tal-irqad-qawmien u l-omeostażi metabolika u kardjovaskulari.
English: Transparency policy
Maltese: Politika ta' trasparenza
English: Mike O'Donovan Mary G. Baker
Maltese: Mike O'Donovan Mary G.
English: 9 April 2009
Maltese: 9 ta' April 2009
English: Presentation ‘Challenges linked to globalisation of clinical trials'.
Maltese: Preżentazzjoni ‘Sfidi relatati mal-globalizzazzjoni ta' provi kliniċi'.
English: The Board discussed the topic and offered divergent views.
Maltese: Il-Bord iddiskuta s-suġġett u offra opinjonijiet diverġenti.
English: Participants at the sixty-second meeting of the Management Board London, 4-5 March 2009 Chair: Pat O'Mahony
Maltese: Parteċipanti fit-tnejn u sittin laqgħa tal-Bord ta' Tmexxija Londra, 4-5 ta' Marzu 2009 President: Pat O'Mahony
English: This includes an estimated fee revenue of €158.3 million and a requested Community contribution of €46 million.
Maltese: Dan jinkludi dħul stmat mill-miżati ta' €158.3 miljun u kontribuzzjoni Komunitarja mitluba ta' €46 miljun.
English: The adopted preliminary draft budget (PDB) for 2010 totals €211.8 million.
Maltese: L-abbozz ta' baġit preliminari adottat (preliminary draft budget - PDB) għall-2010 jammonta għal €211.8 miljun.
English: 4 March 2009
Maltese: 4 ta' Marzu 2009
English: Lisette Tiddens-Engwirda
Maltese: Lisette Tiddens-Engwirda tobba
English: Presentation ‘Future challenges and directions for regulators'.
Maltese: Preżentazzjoni ‘Sfidi u direzzjonijiet futuri għar-regolaturi'.
English: Giuseppe Nisticò Björn Lemmer
Maltese: Il-Parlament Ewropew Giuseppe Nisticò Björn Lemmer
English: [EMEA/MB/632200/2008; EMEA/MB/502942/2008; EMEA/MB/94586/2009; EMEA/MB/579221/ 2008] The Management Board adopted the preliminary draft work programme, budget and staff-policy plan for 2010.
Maltese: [EMEA/MB/632200/2008; EMEA/MB/502942/2008; EMEA/MB/94586/2009; EMEA/MB/579221/ 2008] Il-Bord ta' Tmexxija adotta l-abbozz preliminari ta' programm ta' ħidma, ta' baġit u ta' pjan ta' politika tal-persunal għall-2010.
English: Review of the remuneration system
Maltese: Reviżjoni tas-sistema ta' remunerazzjoni
English: Collaboration with the FDA
Maltese: Kollaborazzjoni mal-FDA
English: The Board supported the amendments proposed by delegations to Articles 2(2) (Responsibilities of chair and vice-chair) and 5(4) (CAT (co)rapporteur and assessment team).
Maltese: Il-Bord appoġġa l-emendi proposti mid-delegazzjonijiet għall-Artikoli 2(2) (Responsabbiltajiet talpresident u tal-viċi-president) u 5(4) ((ko)rapporteur u l-grupp ta' valutazzjoni tas-CAT).
English: Presentation ‘EMEA annual report 2008'.
Maltese: Preżentazzjoni ‘Rapport annwali 2008 tal-EMEA'.
English: The Board nominated Aginus Kalis, Marcus Müllner, Lisette Tiddens and Gro Ramsten Wesenberg as topic coordinators for this project.
Maltese: Il-Bord ħatar lil Aginus Kalis, Marcus Müllner, Lisette Tiddens u Gro Ramsten Wesenberg bħala koordinaturi tematiċi għal dan il-proġett.
English: The two-day meeting opened on Wednesday, 4 March 2009, with presentations and discussions on: future global challenges and directions for regulators; challenges linked to the globalisation of clinical trials; risk-based prioritisation of resources.
Maltese: Il-laqgħa ta' jumejn bdiet l-Erbgħa, 4 ta' Marzu 2009, bi preżentazzjonijiet u diskussjonijiet dwar: sfidi dinjija u direzzjonijiet futuri għar-regolaturi; sfidi marbuta mal-globalizzazzjoni ta' provi kliniċi; prijoritizzazzjoni tar-riżorsi bbażata fuq ir-riskji.
English: Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Maltese: Gro Ramsten Wesenberg (InNorveġja)
English: [EMEA/MB/67287/2009] The Management Board endorsed the proposed amendment under paragraph 4.1.4 (MRL applications, including extrapolations) of the procedural advice for classification and incentives for veterinary medicinal products indicated for minor uses and minor species (MUMS)/limited markets.
Maltese: [EMEA/MB/67287/2009] Il-Bord ta' Tmexxija approva l-emenda proposta skont il-paragrafu 4.1.4 (applikazzjonijiet MRL, inklużi l-estrapolazzjonijiet) tal-parir proċedurali għall-klassifikazzjoni u linċentivi għal prodotti mediċinali veterinarji indikati għal użu minuri u speċi minuri (MUMS)/swieq limitati.
English: EMEA/MB/144834/2009/EN/Adopted
Maltese: EMEA/509571/2009/MT/Adottat
English: [EMEA/86607/2009; EMEA/MB/45112/2009] Reports on EudraVigilance implementation for human medicines and medicines for veterinary use.
Maltese: [EMEA/86607/2009; EMEA/MB/45112/2009] Rapporti dwar l-implimentazzjoni talEudraVigilance għall-mediċini għall-bniedem u għall-mediċini għall-użu veterinarju.
English: Revised organisational structure of the EMEA
Maltese: Stuttura organizzattiva riveduta tal-EMEA
English: [EMEA/MB/673201/2008] The Management Board adopted the proposed mandate of the task force, with a deletion of Point 4, relating to future legislative changes.
Maltese: [EMEA/MB/673201/2008] Il-Bord ta' Tmexxija adotta l-mandat propost tat-task force, bi tneħħija talPunt 4, relatat mal-bidliet leġiżlattivi futuri.
English: Presentation ‘Revised CHMP Rules of Procedure and Interaction between CHMP and CAT'.
Maltese: Preżentazzjoni ‘Regoli ta' Proċedura riveduti tal-CHMP u l-Interazzjoni bejn il-CHMP u l-CAT'.