FrancophonIA/ELRC3.0 huggingface dataset:
English: The children experienced symptoms consistent with previously reported oral overdoses of alpha2-agonist in young children.
Maltese: It-tfal kellhom sintomi konsistenti ma' dożi eċċessivi orali ta' agonisti ta' alfa2 irrappurtati qabel fi tfal żgħar.
English: Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.
Maltese: Għatu li ma jinfetaħx mit-tfal magħmul minn polypropylene (PP) / Polyolefin Termoplastiku (TPOThermoplastic Polyolefin) / polyethylene ta' densità għolja (HDPE - high density polyethylene) u polypropylene (PP).
English: Rare side effects (may affect up to 1 in 1000 people): - hypotension (blood pressure decreased) - heart rate decrease (slow heart rate, known as bradycardia).
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1000): - pressjoni baxxa (tnaqqis fil-pressjoni tad-demm) - tnaqqis fir-rata tal-qalb (rata tal-qalb bil-mod, magħrufa bħala bradikardija).
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polyethylene (PE) child resistant closure
Maltese: Tubi tal-polifojl tal-Polyethylene (PE)/Kopolimer/Aluminju (Al)/ Kopolimer/Polyethylene (PE) bil-parti ta' quddiem magħmula minn polyethylene ta' densità għolja (HDPE - high density polyethylene) u għatu li ma jinfetaħx mit-tfal magħmul minn polyethylene (PE).
English: - if you are taking certain medicines used for depression or Parkinson's disease including so-called monoamine oxidase (MAO) inhibitors (for example selegiline or moclobemide) or tricyclic antidepressants (such as imipramine) or tetracyclic antidepressants (such as maprotiline, mianserin or mirtazapin).
Maltese: - jekk qed tieħu ċerti mediċini użati għad-dipressjoni jew għall-marda tal-Parkinson inkluż 'l hekk imsejħa inibituri ta' monoamine oxidase (MAO) (pereżempju selegiline jew moclobemide) jew antidipressanti triċikliċi (bħal imipramine) jew antidepressanti tetraċikliċi (bħal maprotiline, mianserin jew mirtazapin).
English: Excipient(s) with known effect:
Maltese: Eċċipjenti b'effett magħruf:
English: 3 hours after application 22.8% 6 hours after application 26.6% 9 hours after application 20.3% 12 hours after application 21.5% Day 29 p-value
Maltese: 12-il siegħa wara l-applikazzjoni 22.8% 8.6% Valur p f'jum 29
English: Caution is advised when initiating (or changing the dose of) a concomitant systemic substance (irrespective of pharmaceutical form) which may interact with alpha adrenergic receptor agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor e.g. (isoprenaline, prazosin).
Maltese: Huwa rrakkomandat li tingħata attenzjoni meta tinbeda (jew meta jkun hemm bidla fid-doża ta') sustanza sistemika fl-istess waqt (irrispettivament mill-għamla farmaċewtika) li tista' tinteraġixxi ma' agonisti tar-riċettur alfa adrenerġiku jew tinterferixxi mal-attività tagħhom, jiġifieri agonisti jew antagonisti tar-riċettur adrenerġiku (eż. isoprenaline, prazosin).
English: All enrolled subjects received a single-day ocular administration of a 0.2% eye drops solution of brimonidine followed by a once daily cutaneous application of Mirvaso for 29 days (intra-individual comparison of systemic exposure).
Maltese: L-individwi kollha rreġistrati rċevew għoti fl-għajn f'ġurnata waħda ta' soluzzjoni ta' qtar għall-għajnejn ta' 0.2% brimonidine segwit minn applikazzjoni fuq il-ġilda ta' Mirvaso darba kuljum għal 29 jum (paragun bejn l-individwi tal-esponiment sistemiku).
English: Table 3: Percentage of subjects with severe erythema at baseline Day 1 (CEA or PSA grade 4) with 2-grade improvement in both CEA and PSA
Maltese: Tabella 3: Perċentwal ta' individwi b'eritema severa f'Jum 1 linja bażi (CEA jew PSA grad 4) b'titjib ta' 2 gradi kemm f'CEA kif ukoll f'PSA
English: Do not use this medicine after the expiry date which is stated on the carton, tube and pump after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi wara EXP li tidher fuq il-kartuna, it-tubu u lpompa.
English: No clinically meaningful trends with respect to tachyphylaxis or rebound effects (worsening of baseline erythema after cessation of treatment) were observed with use of Mirvaso for 29 days.
Maltese: L-ebda tendenza klinikament sinifikanti rigward l-effetti ta' takifilassi jew ta' ritorn (aggravar ta' eritema fil-linja bażi wara waqfien tal-kura) ma ġiet osservata bl-użu ta' Mirvaso għal 29 jum.
English: Caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides concomitantly with brimonidine.
Maltese: Għalhekk hija rrakkomandata attenzjoni waqt l-użu ta' prodotti mediċinali bħal sustanzi kontra l-pressjoni għolja u/jew glycosides kardijaċi flimkien ma' brimonidine.
English: This is particularly important in children under the age of 2 years (see ‘Do not use Mirvaso').
Maltese: Dan huwa partikolarment importanti fi tfal taħt l-età ta' sentejn (ara ‘TUŻAX Mirvaso').
English: Montdésir 74540 Alby-sur-Chéran France or
Maltese: Laboratoires Galderma Z.I. Montdésir 74540
English: Uncommon side effects (may affect up to 1 in 100 people): - acne - dry mouth - feeling cold in hands and feet - feeling hot - headache - nasal congestion - swelling of the eyelid - urticaria - dizziness
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): - akne - ħalq xott - tħoss kesħa fl-idejn u s-saqajn - tħoss is-sħana - uġigħ ta' ras - konġestjoni fl-imnieħer - nefħa tal-kappell tal-għajn - ħakk - sturdament
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/904/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/904/006
English: Moderate to severe erythema was defined as a grade 3 or greater on both the Clinician Erythema Assessment (CEA) scale and Patient Self-Assessment (PSA) scale.
Maltese: Eritema moderata għal severa ġiet definita bħala grad 3 jew akbar kemm fuq l-iskala Valutazzjoni tal-Eritema minn Professjonista tal-Kura tas-Saħħa (CEA - Clinician Erythema Assessment) kif ukoll fil-Valutazzjoni tal-Pazjent Innifsu (PSA - Patient Self-Assessment).
English: The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
Maltese: Il-possibbiltà ta' effett addittiv jew li jsaħħaħ fuq depressanti tas-sistema nervuża ċentrali (alkoħol, barbiturates, opiates, sedattivi, jew anestetiċi) għandha tiġi kkunsidrata.
English: Contact your doctor immediately or go to a hospital emergency department right away if you, a child, or anyone else swallows this medicine and has any of these symptoms: feeling dizzy from low blood pressure, vomiting, tiredness or drowsiness, decreased or irregular heartbeats, small pupils (constricted pupils), difficult or slow breathing, floppiness, low body temperature and convulsions (fits).
Maltese: Ikkuntattja lit-tabib tiegħek immedjatament jew mur id-dipartiment tal-emerġenza ta' sptar minnufih, jekk inti, tifel/tilfa, jew xi ħadd ieħor jibla' din il-mediċina u għandu/ha xi wieħed minn dawn is-sintomi: sturdament minħabba pressjoni tad-demm baxxa, rimettar, għeja jew ngħas, taħbit tal-qalb imnaqqas jew irregolari, ħabba tal-għajn baxxa (kontrazzjoni tal-ħabba tal-għajn), teħid tan-nifs diffiċli jew b'rata baxxa, telqa, temperatura tal-ġisem baxxa u konvulżjonijiet (fits).
English: The medicinal product contains methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed), and propylene glycol (E1520) which may cause skin irritation.
Maltese: Il-prodott mediċinali fih methylparahydroxybenzoate (E218) li jista' jikkawża reazzjonijiet allerġiċi (li għandhom mnejn ikunu ttardjati), u propylene glycol (E1520)li jista' jikkawża irritazzjoni fil-ġilda.
English: Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.
Maltese: Mirvaso hu indikat għall-kura sintomatika tal-eritema ta' rosaċea fil-wiċċ f'pazjenti adulti.
English: No adverse reactions had an increase in frequency over time, and there was no evidence that long-term use of Mirvaso conveyed an increased risk of occurrence of any specific type of adverse reaction.
Maltese: Ebda reazzjoni avversa ma kellha żieda fil-frekwenza maż-żmien, u ma kien hemm ebda evidenza li użu fit-tul ta' Mirvaso wassal għal riskju miżjud ta' okkorrenza ta' xi tip speċifiku ta' reazzjoni avversa.
English: Cutaneous facial application of a highly selective alpha2-adrenergic receptor agonist reduces erythema through direct cutaneous vasoconstriction.
Maltese: Applikazzjoni fuq il-ġilda tal-wiċċ ta' agonista selettiv ħafna tar-riċettur alfa2 adrenerġiku tnaqqas l-eritema permezz ta' vażokostrizzjoni diretta fil-ġilda.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3). Bħala prekawzjoni hu preferibbli li ma jintużax Mirvaso waqt it-tqala.
English: - you have depression, decreased blood flow to the brain or the heart, fall in blood pressure on standing up, decreased blood flow to the hands, feet or skin, or Sjögren's syndrome (a chronic disease in which the body's natural defence - the immune system - attacks the moisture-producing glands).
Maltese: - għandek depressjoni, fluss ta' demm imnaqqas lejn il-moħħ jew il-qalb, inżul f'daqqa tal-pressjoni tad-demm meta tqum bil-wieqfa, fluss ta' demm imnaqqas fl-idejn, saqajn jew ġilda, jew is-sindrome ta' Sjögren (marda kronika li fiha, id-difiża naturali tal-ġisem is-sistema immuni - tattakka l-glandoli li jipproduċu l-ilma). - għandek jew kellek problemi bil-kliewi jew bil-fwied jew kellek problemi bħal dawn fil-passat.
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE 17.
English: Concomitant use of Mirvaso with other medicinal products for the treatment of inflammatory lesions of rosacea has not been systematically investigated.
Maltese: L-użu konkomittanti ta' Mirvaso ma' prodotti mediċinali oħrajn għall-kura ta' leżjonijiet infjammatorji ta' rosacea ma ġiex investigat b'mod sistematiku.
English: Caution, however, is advised in patients taking substances which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.
Maltese: Madankollu, huwa rrakkomandat li tingħata attenzjoni f'pazjenti li jkunu qed jieħdu sustanzi li jistgħu jaffettwaw il-metaboliżmu u t-teħid ta' amines li jkunu qed jiċċirkolaw eż. chlorpromazine, methylphenidate, reserpine.
English: On Day 1 of the study, all subjects received 1 drop of the 0.2% eye drops solution in each eye, every 8 hours over a 24-hour period (3 doses in total).
Maltese: F'Jum 1 tal-istudju, l-individwi kollha rċevew qatra waħda taż-0.2 % soluzzjoni ta' qtar tal-għajnejn f'kull għajn, kull 8 sigħat fuq perjodu ta' 24 siegħa (3 dożi b'kollox).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Mirvaso in all subsets of the paediatric population in treatment of rosacea (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Do not take Mirvaso with selegiline, moclobemide, imipramine, mianserin, or maprotiline, which are medicines that can be used for depression or Parkinson's disease, as this could lead to a change in the effectiveness of Mirvaso or could increase the chances for side effects such as a fall in blood pressure (see under ‘Do not use Mirvaso').
Maltese: Tiħux Mirvaso ma' selegiline, moclobemide, imipramine, mianserin, jew maprotiline, li huma mediċini li jistgħu jintużaw għal kontra d-depressjoni jew għall-marda tal-Parkinson, minħabba li dan jista' jwassal għal bidla fl-effikaċja ta' Mirvaso jew jista' jżid iċ-ċans li jiżviluppaw effetti sekondarji bħal inżul f'daqqa tal-pressjoni tad-demm (ara taħt ‘Tużax Mirvaso').
English: Mirvaso may also cause the following other side effects:
Maltese: Mirvaso jista' jikkawża wkoll l-effetti sekondarji oħrajn li ġejjin:
English: The efficacy of Mirvaso in the treatment of moderate to severe facial erythema of rosacea has been demonstrated in two randomised, vehicle controlled blinded clinical trials, which were identical in design.
Maltese: L-effikaċja ta' Mirvaso fil-kura ta' eritema moderata sa severa kkawżata minn rosaċea fil-wiċċ intweriet f'żewġ provi kliniċi ‘blinded' randomizzati kkontrollati b'ġell mingħajr sustanza attiva, li kienu identiċi fid-disinn.
English: Table 2: Percentage of subjects with a 2-grade improvement in both CEA and PSA
Maltese: Tabella 2: Perċentwal ta' individwi b'titjib ta' 2 gradi kemm f'CEA kif ukoll f'PSA
English: a.) Revised terms of reference
Maltese: a.) Termini ta' referenza riveduti
English: Alternates (and other participants)
Maltese: Supplenti (u parteċipanti oħra)
English: Chair: Sir Kent Woods
Maltese: President: Sir Kent Woods
English: Substances of human origin (SoHO)
Maltese: Sustanzi ta' oriġini umana (SoHO)
English: Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Gro Wesenberg (Norway)
Maltese: Rannveig Gunnarsdóttir (L-Islanda) Brigitte Batliner (Il-Liechtenstein) Gro Wesenberg (In-Norveġja)
English: Mary Baker Apologies from Mike O'Donovan
Maltese: Mary Baker Apoloġiji minn Mike O'Donovan
English: Andreas Pott Patrick Le Courtois David Mackay Hans-Georg Wagner Noël Wathion Martin Harvey Allchurch Isabelle Moulon Frances Nuttall Vincenzo Salvatore Fergus Sweeney Zuzana O'Callaghan Nerimantas Steikūnas
Maltese: Andreas Pott Patrick Le Courtois David Mackay Hans-Georg Wagner Noël Wathion Martin Harvey Allchurch Isabelle Moulon Frances Nuttall Vincenzo Salvatore Fergus Sweeney Zuzana
English: 15 Romania 16 Slovakia 17 Slovenia 18 Sweden 19 United Kingdom 20 Mary Baker 21 Mike O'Donovan by proxy
Maltese: Ir-Rumanija 16 Is-Slovakkja 17 Is-Slovenja 18 L-Isvezja 19 Ir-Renju Unit 20 Mary Baker 21 Mike O'Donovan bi prokura
English: b.) MBTC chairmanship arrangements
Maltese: b.) Arranġamenti tal-presidenza tal-MBTC
English: Reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems
Maltese: Dokument ta' riflessjoni dwar in-nuqqas ta' provvista ta' prodotti mediċinali minħabba problemi ta' manifattura/konformità mal-prattiki tajba ta' manifattura (GMP)
English: Against
Maltese: Kontra
English: Veterinarian organisations
Maltese: Organizzazzjonijiet veterinarji
English: Pedro Ortun Silvan (DG Enter) gives his vote by proxy to Paola Testori-Coggi (DG Sanco).
Maltese: Pedro Ortun Silvan (DĠ Enter) jagħti l-vot tiegħu bi prokura lil Paola Testori-Coggi (DĠ Sanco).
English: Pedro Ortun Silvan by proxy
Maltese: Pedro Ortun Silvan bi prokura
English: Ioannis Toutas (Greece) gives his vote by proxy to Pat O'Mahony (Ireland).
Maltese: Ioannis Toutas (Greċja) jagħti l-vot tiegħu bi prokura lil Pat O'Mahony (Irlanda).
English: Meeting with Commissioner John Dalli and Director-General Paola Testori
Maltese: Laqgħa mal-Kummissarju John Dalli u d-Direttur Ġenerali Paola Testori
English: The budget is in line with the work programme and totals €222.5 million (6.5% increase over the 2011 budget), which includes a general EU contribution of €23 million, the 2010 surplus of €9.9 million and the €6 million orphan medicinal products fund.
Maltese: Il-baġit huwa konformi mal-programm ta' ħidma u jammonta għal €222.5 miljuni (żieda ta' 6.5% fuq il-baġit tal-2011), li jinkludu kontribuzzjoni ġenerali ta' €23 miljun mill-UE, l-eċċess ta' €9.9 miljuni mill-2010 u l-fond ta' €6 miljun tal-prodotti mediċinali orfni.
English: Held in London on 15 December 2011
Maltese: Li saret f'Londra fil-15 ta' Diċembru 2011
English: George Antoniou (Cyprus) gives his vote by proxy to Patricia Vella Bonanno (Malta).
Maltese: 3. George Antoniou (Ċipru) jagħti l-vot tiegħu bi prokura lil Patricia Vella Bonanno (Malta).
English: EMA/MB/33634/2012 Adopted Management Board
Maltese: EMA/MB/33634/2012 Adottat Bord ta' Tmexxija
English: 8 Germany 9 Greece by proxy 10 Ireland 11 Italy
Maltese: 8 Il-Ġermanja 9 Il-Greċja bi prokura 10 L-Irlanda 11 L-Italja 12 Il-Latvja 13 Il-Litwanja 14 Malta
English: 7 Finland
Maltese: 7 Il-Finlandja
English: Mike O'Donovan gives his vote by proxy to Mary G Baker.
Maltese: 1. Mike O'Donovan jagħti l-vot tiegħu bi prokura lil Mary G Baker.
English: • [EMA/876327/2011] EMA preparations for the impact of the Olympic Games 2012.
Maltese: • [EMA/876327/2011] It-tħejjijiet tal-EMA għall-impatt tal-Logħob Olimpiċi 2012.
English: [EMA/MB/886045/2011; EMA/121340/2011] The Management Board endorsed the reflection paper.
Maltese: [EMA/MB/886045/2011; EMA/121340/2011] Il-Bord ta' Tmexxija approva d-dokument ta' riflessjoni.
English: • Revised draft agenda version 3.0.
Maltese: • Abbozz tal-aġenda rivedut verżjoni 3.0.
English: [EMA/MB/826035/2011] The agenda was adopted.
Maltese: [EMA/MB/826035/2011] L-aġenda ġiet adottata.
English: Management Board Telematics Committee (MBTC)
Maltese: Kumitat tat-Telematika tal-Bord ta' Tmexxija (MBTC)
English: • Progress on identifying commercially confidential information (a revised guidance document will be presented at the next HMA meeting in February 2012).
Maltese: • Il-progress fl-identifikazzjoni ta' informazzjoni kummerċjali kunfidenzjali (dokument ta' gwida rivedut ser ikun ippreżentat fil-laqgħa li jmiss tal-HMA fi Frar 2012).
English: Draft reflection paper on ethical and GCP aspects of clinical trials
Maltese: Abbozz ta' dokument ta' riflessjoni dwar l-aspetti etiċi u ta' GCP (prassi klinika tajba) tal-provi kliniċi
English: A reflection paper on veterinary product supply shortages should be discussed.
Maltese: Għandu jiġi diskuss dokument ta' riflessjoni fuq in-nuqqas ta' provvisti ta' prodotti veterinarji.
English: Claude Hemmer (Luxembourg) gives his vote by proxy to Aginus Kalis (Netherlands).
Maltese: 4. Claude Hemmer (Lussemburgu) jagħti l-vot tiegħu bi prokura lil Aginus Kalis (Pajjiżi l-Baxxi).
English: [EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] The Management Board endorsed the IAS strategic audit plan for 2012-2014.
Maltese: [EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] Il-Bord ta' Tmexxija approva l-pjan strateġiku ta' verifika tal-IAS għall-2012-2014.
English: The document was not adopted in its current form, and a revised policy will be submitted at the March 2012 meeting.
Maltese: Id-dokument ma ġiex adottat fis-sura attwali tiegħu, u politika riveduta sejra tkun ippreżentata fil-laqgħa ta' Marzu 2012.
English: d.) ICT budgets and projects for 2012
Maltese: d.) Baġits tal-ICT u proġetti għall-2012
English: The Board discussed the proposal to introduce restrictions in certain cases where potential conflicts of interests can be perceived.
Maltese: Il-Bord iddiskuta l-proposta li jintroduċi restrizzjonijiet f'ċerti każijiet fejn jistgħu jiġu pperċepiti kunflitti ta' interess potenzjali.
English: List of participants at the 74th meeting of the Management Board, held in London on 15 December 2011
Maltese: Lista ta' parteċipanti fl-74 laqgħa tal-Bord ta' Tmexxija, li saret f'Londra fil-15 ta' Diċembru 2011
English: [EMA/MB/901680/2011; EMA/901869/2011] The Management Board endorsed the implementing activities for 2012.
Maltese: [EMA/MB/901680/2011; EMA/901869/2011] Il-Bord ta' Tmexxija approva l-attivitajiet ta' implimentazzjoni għall-2012.
English: 11bis Preparation for written procedures: Non-automatic carry-over 2011-2012
Maltese: 11bis Tħejjija għall-proċeduri bil-miktub: Trasferiment mhux awtomatiku 2011-2012
English: [EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] The Management Board endorsed the new framework for interaction with healthcare professionals (HCPs) and the criteria that apply to HCP organisations wishing to be involved in the Agency's activities.
Maltese: [EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] Il-Bord ta' Tmexxija approva l-qafas il-ġdid għall-interazzjoni mal-professjonisti tal-kura tas-saħħa (healthcare professionals - HCPs) u lkriterji li japplikaw għall-organizzazzjonijiet tal-HCP li jixtiequ jkunu involuti fl-attivitajiet tal-Aġenzija.
English: • [EMA/MB/902317/2011] Summary of transfers of appropriations in the budget 2011.
Maltese: • [EMA/MB/902317/2011] Sommarju tat-trasferimenti tal-approprjazzjonijiet fil-baġit għall-2011.
English: • Communication about the network during international meetings, emphasising the complementarity of the EU system.
Maltese: • Il-komunikazzjoni dwar in-netwerk waqt il-laqgħat internazzjonali, li tenfasizza l-kumplimentarjetà tas-sistema tal-UE.
English: • No 12/2011 - the appointment of Alia Michaelidou-Patsia as CVMP alternate, proposed by Cyprus, finalised on 28 November 2011.
Maltese: • Nru 12/2011 - - il-ħatra ta' Alia Michaelidou-Patsia bħala supplenti tas-CVMP, proposta minn Ċipru, iffinalizzata fit-28 ta' Novembru 2011.
English: [EMA/MB/828587/2011] The Management Board noted the final minutes, adopted by written procedure on 23 November 2011.
Maltese: [EMA/MB/828587/2011] Il-Bord ta' Tmexxija ħa nota tal-minuti finali, adottati permezz ta' proċedura bil-miktub fit-23 ta' Novembru 2011.
English: [EMA/907384/2011] The Management Board adopted a change to the terms of reference of the Committee.
Maltese: [EMA/907384/2011] Il-Bord ta' Tmexxija adotta bidla fit-termini ta' referenza tal-Kumitat.
English: • The implementation of the pharmacovigilance legislation (seven implementing measures are being prepared; public consultation finished in November 2011; the most relevant measure, which is relevant for national authorities, sets out minimum requirements for the pharmacovigilance system applied at NCA level).
Maltese: • L-implimentazzjoni tal-leġiżlazzjoni dwar il-farmakoviġilanza (qegħdin jitħejjew seba' miżuri implimentattivi; il-konsultazzjoni pubblika ntemmet f'Novembru 2011; l-aktar miżura rilevanti, li hija rilevanti għall-awtoritajiet nazzjonali, tistabbilixxi rekwiżiti minimi għas-sistema ta' farmakoviġilanza applikata fil-livell tal-NCAs).
English: • No 11/2011 - the appointment of Frederic Klein as CVMP alternate, proposed by Belgium, finalised on 19 October 2011.
Maltese: • Nru 11/2011 - - il-ħatra ta' Frederic Klein bħala supplenti tas-CVMP, proposta mill-Belġju, iffinalizzata fid-19 ta' Ottubru 2011.
English: IAS strategic audit plan for 2012-2014
Maltese: Pjan strateġiku ta' verifika tal-IAS għall-2012-2014
English: [EMA/MB/880875/2011] The Management Board endorsed the adaptation of the fixed hourly cost to €41 for the year 2012 (the cost had been €40 since 2009).
Maltese: [EMA/MB/880875/2011] Il-Bord ta' Tmexxija approva l-adattament tal-ispiża b'rata fissa fis-siegħa ta' €41 għas-sena 2012 (l-ispiża kienet ilha €40 sa mill-2009).
English: • Adoption of 73rd Management Board meeting minutes finalised on 25 November 2011.
Maltese: • L-Adozzjoni tal-minuti tat-73 laqgħa tal-Bord ta' Tmexxija ffinalizzata fil-25 ta' Novembru 2011.
English: Vote on the adoption of agenda item 7c - MB conflicts of interests policy
Maltese: Vot fuq l-adozzjoni tal-partita 7c tal-Aġenda - Il-politika dwar il-kunflitti ta' interess tal-MB
English: Overall, the budget is €15.9 million lower than the preliminary draft budget adopted in March 2011.
Maltese: B'mod globali, il-baġit huwa €15.9 miljun inqas mill-abbozz tal-baġit preliminari adottat f'Marzu tal-2011.
English: [EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] The Board discussed the issue of supply shortages, considering it to be of importance to public health.
Maltese: [EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] Il-Bord iddiskuta l-kwistjoni ta' nuqqas ta' provvisti, minħabba li jikkunsidra li din hija importanti għas-saħħa pubblika.
English: [EMA/MB/554514/2011] The Management Board adopted the work programme 2012.
Maltese: [EMA/MB/554514/2011] Il-Bord ta' Tmexxija adotta l-programm ta' ħidma għall-2012.
English: Report from the Heads of Medicines Agencies (HMA)
Maltese: Rapport mill-Kapijiet tal-Aġenziji tal-Mediċini (Heads of Medicines Agencies - HMA)