FrancophonIA/ELRC3.0 huggingface dataset:
English: This was the last Management Board meeting for Hans-Georg Wagner, Head of Information and Communications Technology (ICT) Unit, who was shortly to retire after serving with the Agency since May 2002.
Maltese: Din kienet l-aħħar laqgħa tal-Bord ta' Tmexxija għal Hans-Georg Wagner, Kap tat-Taqsima tatTeknoloġija tal-Informazzjoni u tal-Komunikazzjoni (Information and Communications TechnologyICT), li kien ser jirtira wara li serva fl-Aġenzija sa minn Mejju 2002.
English: The Management Board also adopted a revision of the grading of the 23 posts in accordance with Article 32 of the Agency's Financial Regulation.
Maltese: Il-Bord ta' Tmexxija adotta wkoll reviżjoni tal-gradi tat-23 kariga skont l-Artikolu 32 tal-Regolament Finanzjarju tal-Aġenzija.
English: A number of projects are under way that will see streamlining of certain procedures and the introduction of more quantifiable elements in the assessment process.
Maltese: Għaddejjin għadd ta' proġetti li sejrin jissimplifikaw ċerti proċeduri u jintroduċu elementi aktar kwantifikabbli fil-proċess ta' evalwazzjoni.
English: European Commission Paola Testori Coggi Apologies from Pedro Ortum Silvan
Maltese: Il-Parlament Ewropew Giuseppe Nisticó Björn Lemmer Il-Kummissjoni Ewropea Paola Testori Coggi Apoloġiji minn Pedro Ortum Silvan
English: • EU database for veterinary medicines (in light of the revision of the veterinary legislation, the HMA reflected on a global strategic direction with regard to its IT infrastructure, particularly in the area of medicinal products databases).
Maltese: • Id-dejtabejż tal-UE għall-mediċini veterinarji (fid-dawl tar-reviżjoni tal-leġiżlazzjoni veterinarja, lHMA irrifletta dwar direzzjoni strateġika globali fir-rigward tal-infrastruttura tal-IT tiegħu, b'mod partikolari fil-qasam tad-dejtabejżis tal-prodotti mediċinali).
English: In the current financial situation, the contribution is not likely to be increased.
Maltese: Fis-sitwazzjoni finanzjarja attwali, aktarx li l-kontribuzzjoni ma tiżdiedx.
English: • The cross-border directive (progress has been achieved in setting up a voluntary cooperation structure with Member States in the area of health technology assessment; a network of Member States in the e-health area was established; a new proposal on cross-border health threats was adopted).
Maltese: • Id-direttiva transkonfinali (sar progress fit-twaqqif ta' struttura ta' kooperazzjoni volontarja malIstati Membri fil-qasam tal-evalwazzjoni tat-teknoloġija tas-saħħa; ġie stabbilit netwerk ta' Stati Membri fil-qasam tas-saħħa elettronika; ġiet adottata proposta ġdida dwar it-theddid għas-saħħa transkonfinali).
English: [EMA/MB/115339/2004/Rev.3] The Management Board adopted changes to the Management Board rules of procedure.
Maltese: [EMA/MB/115339/2004/Rev.3] Il-Bord ta' Tmexxija adotta bidliet fir-regoli ta' proċedura tal-Bord ta' Tmexxija.
English: 6 Estonia
Maltese: L-Estonja
English: Andreas Pott had been appointed as Deputy Executive Director of the Agency effective 1 December 2011.
Maltese: Andreas Pott kien inħatar bħala Deputat Direttur Eżekuttiv tal-Aġenzija b'effett mill1 ta' Diċembru 2011.
English: The Board also decided to invite the current civil society representativesMary Baker, Mike O'Donovan and Lisette Tiddens - to participate at the next meeting as observers, to enable them to provide valuable input to the work of the Board.
Maltese: IlBord iddeċieda wkoll li jistieden lir-rappreżentanti tas-soċjetà ċivili attwali - Mary Baker, Mike O'Donovan u Lisette Tiddens - sabiex jipparteċipaw fil-laqgħa li jmiss bħala osservaturi, sabiex ikunu jistgħu jagħtu kontribut siewi għax-xogħol tal-Bord.
English: The Board took the opportunity to thank the topic coordinators (Xavier De Cuyper, Walter Schwerdtfeger and Lisette Tiddens) for preparing this topic for the discussion, and will look forward to a further discussion at the next meeting.
Maltese: Il-Bord ħa l-opportunità sabiex jirringrazzja lill-koordinaturi tas-suġġett (Xavier De Cuyper, Walter Schwerdtfeger u Lisette Tiddens) għat-tħejjija ta' dan is-suġġett għad-diskussjoni, u huwa ħerqan li ssir aktar diskussjoni fil-laqgħa li jmiss.
English: Taking into account that the current memberships on the Board of Lisette Tiddens and Mike O'Donovan expire on 4 March 2012, as do their mandates as Chair and a member of the MBTC respectively, and pending new appointments of the civil society representatives to the Board, the meeting decided to appoint Kent Woods as interim Chair of the MBTC effective 5 March 2012.
Maltese: Minħabba li l-isħubija attwali ta' Lisette Tiddens u Mike O'Donovan fuq il-Bord tiskadi fl4 ta' Marzu 2012, bħall-mandati tagħhom bħala President u membru tal-MBTC rispettivament, u sakemm jinħatru r-rappreżentanti tas-soċjetà ċivili fuq il-Bord, il-laqgħa ddeċidiet li taħtar lil Kent Woods bħala President temporanju tal-MBTC b'effett mill-5 ta' Marzu 2012.
English: [EMA/MB/239263/2011] The Management Board adopted amendments to the fee implementing rules.
Maltese: [EMA/MB/239263/2011] Il-Bord ta' Tmexxija adotta l-emendi għar-regoli implimentattivi tal-miżati.
English: [EMA/MB/924270/2011; EMA/914836/2011] This item (for information) was deferred to the next meeting.
Maltese: [EMA/MB/924270/2011; EMA/914836/2011] Dan is-suġġett (għall-informazzjoni) ġie differit għallaqgħa li jmiss.
English: In favour
Maltese: Favur
English: Bulgaria
Maltese: Il-Bulgaria
English: This is then followed by a signal management procedure.
Maltese: Dan ikun segwit minn proċedura ta' ġestjoni tas-sinjali.
English: The Management Board thanked the topic coordinators Aginus Kalis, Marcus Müllner, Pat O'Mahony and Kent Woods for their contribution in preparing the topics on the work programme and the budget for the discussion.
Maltese: Il-Bord ta' Tmexxija radd ħajr lill-koordinaturi tas-suġġetti Aginus Kalis, Marcus Müllner, Pat O'Mahony u Kent Woods għall-kontribut tagħhom fit-tħejjija tas-suġġetti tal-programm ta' ħidma u tal-baġit għad-diskussjoni.
English: Project 2014 - move to new premises
Maltese: Proġett 2014 - it-trasferiment f'post ġdid
English: Nomination to the new Pharmacovigilance Risk Assessment Committee (PRAC)
Maltese: Nomina għall-Kumitat Konsultattiv il-ġdid dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (Pharmacovigilance Risk Assessment Committee - PRAC)
English: [EMA/MB/834867/2011] The Management Board welcomed the proposed revisions to the Management Board policy on conflicts of interests.
Maltese: [EMA/MB/834867/2011] Il-Bord ta' Tmexxija laqa' r-reviżjonijiet proposti għall-politika tal-Bord ta' Tmexxija dwar il-kunflitti ta' interess.
English: • No 10/2011 - the appointment of Eva Persson as CVMP alternate, proposed by Sweden, finalised on 19 October 2011.
Maltese: • Nru 10/2011 - il-ħatra ta' Eva Persson bħala supplenti tas-CVMP, proposta mill-Isvezja, iffinalizzata fid-19 ta' Ottubru 2011.
English: 9 February 2012
Maltese: 9 ta' Frar 2012
English: • [EMA/907269/2011] EU telematics projects report; [EMA/907270/2011] EU telematics operations report; [EMA/907383/2011] Minutes from the Management Board Telematics Committee meeting held on 22 September 2011.
Maltese: • [EMA/907269/2011] Rapport dwar il-proġetti tat-telematika tal-UE;
English: • Letter from the European Commission, Paola Testori Coggi, regarding EU level support in the field of tissues and cells.
Maltese: • Ittra mill-Kummissjoni Ewropea, Paola Testori Coggi, rigward l-appoġġ fil-livell tal-UE fil-qasam tattessuti u ċ-ċelloli.
English: a.) The work programme 2012
Maltese: a.) Il-programm ta' ħidma 2012
English: EMA conflicts of interests policies a.) Second update on the implementation of the conflicts of interests policy for experts
Maltese: Il-politiki tal-EMA dwar il-kunflitti ta' interess a.) It-tieni aġġornament dwar l-implimentazzjoni tal-politika dwar il-kunflitti ta' interess għall-esperti
English: Interaction between the Agency and healthcare professionals a.) Framework for interaction between the Agency and healthcare professionals, and b.) Criteria to be fulfilled by healthcare professionals' organisations involved in Agency activities
Maltese: Interazzjoni bejn l-Aġenzija u l-professjonisti tal-kura tas-saħħa a.) Qafas għall-interazzjoni bejn l-Aġenzija u l-professjonisti tal-kura tas-saħħa, u b.) Kriterji li għandhom ikunu ssodisfati mill-organizzazzjonijiet tal-professjonisti tal-kura tas-saħħa involuti fl-attivitajiet tal-Aġenzija
English: Communication, transparency, future veterinary legislation, interactions with health technology assessment (HTA) bodies, process reengineering to increase efficiency of operations, and assuring functioning of the Agency during the busy Olympic period in London will be other areas of focus for
Maltese: Il-komunikazzjoni, it-trasparenza, leġiżlazzjoni veterinarja fil-futur, interazzjonijiet ma' korpi ta' evalwazzjoni tat-teknoloġija tas-saħħa (health technology assessment - HTA), l-ippjanar mill-ġdid tal-proċessi sabiex tiżdied l-effiċjenza taloperazzjonijiet, u l-iżgurar tal-funzjonament tal-Aġenzija matul il-perjodu impenjattiv tal-Olimpjadi f'Londra sejrin ikunu oqsma oħra ta' ffukar għall-2012.
English: [EMA/MB/856505/2011] The Management Board noted the information on the ICT budget and the projects planned for 2012.
Maltese: [EMA/MB/856505/2011] Il-Bord ta' Tmexxija ħa nota tal-informazzjoni dwar il-baġit tal-ICT u l-proġetti ppjanati għall-2012.
English: The Management Board adopted the establishment plan for 2012 of 590 posts, which increases the number of temporary agent (TA) posts by 23 for the implementation of the pharmacovigilance legislation.
Maltese: Il-Bord ta' Tmexxija adotta l-pjan ta' stabbiliment għall-2012 ta' 590 post tax-xogħol, li jżid l-għadd ta' karigi ta' aġenti temporanji (AT) bi 23 għall-implimentazzjoni tal-leġiżlazzjoni dwar il-farmakoviġilanza.
English: The planned fee revenue is increased by 7.5% over the 2011 budget to €173 million, in line with the increased number of applications and workload.
Maltese: Id-dħul ippjanat mill-miżati żdied b'7.5% fuq il-baġit tal-2011 għal €173 miljun, f'konformità maż-żieda fl-għadd ta' applikazzjonijiet u fl-ammont ta' xogħol.
English: [EMA/MB/882002/2011] The Management Board noted that a written procedure for non-automatic carry-forward will be launched for adoption no later than 15 February 2012.
Maltese: [EMA/MB/882002/2011] Il-Bord ta' Tmexxija innota li proċedura bil-miktub għat-trasferiment mhux awtomatiku sejra tiġi mnedija għall-adozzjoni sa mhux aktar tard mill-15 ta' Frar 2012.
English: [EMA/MB/902165/2011] The mid-year report showed positive trends in the area of signal detection and management.
Maltese: [EMA/MB/902165/2011] Ir-rapport ta' nofs is-sena wera tendenzi pożittivi fil-qasam tas-sejbien u lġestjoni tas-sinjali.
English: Some of the factors contributing to supply shortages are trade issues, concentration and economics of manufacturing, and the drive for cost savings in healthcare systems.
Maltese: Xi wħud mill-fatturi li jikkontribwixxu għan-nuqqas ta' provvisti huma kwistjonijiet kummerċjali, ilkonċentrazzjoni u l-ekonomija tal-manifattura, u t-tendenza tal-iffrankar fis-sistemi tal-kura tas-saħħa.
English: • [EMA/MB/868582/2011] Outcome of written procedures during the period 15 September 2011 to
Maltese: • [EMA/MB/868582/2011] Eżitu tal-proċeduri bil-miktub matul il-perjodu ta' bejn il15 ta' Settembru 2011 u t-30 ta' Novembru 2011.
English: The framework focuses on the following areas of interaction: accessing the best-possible expertise, contributing to a more efficient and targeted communication to healthcare professionals, and enhancing HCP organisations' understanding of the role of the Agency and of the network.
Maltese: Il-qafas jiffoka fuq dawn l-oqsma ta' interazzjoni li ġejjin: l-aċċess għall-aqwa kompetenza possibbli, ilkontribut għal komunikazzjoni aktar effiċjenti u mmirata lill-professjonisti tal-kura tas-saħħa, u t-titjib tal-fehim tal-organizzazzjonijiet tal-HCP dwar ir-rwol tal-Aġenzija u tan-netwerk.
English: 2011 EudraVigilance-Human mid-year report
Maltese: Rapport mill-Kummissjoni Ewropea
English: [EMA/MB/811207/2011] The Management Board endorsed the report on the Agency's procurement procedure and the proposed improvement action plan.
Maltese: [EMA/MB/811207/2011] Il-Bord ta' Tmexxija approva r-rapport dwar il-proċedura tal-akkwist talAġenzija u l-proposta ta' pjan ta' azzjoni ta' titjib.
English: 30 November 2011.
Maltese: Page 14/15
English: • The implementation of the falsified medicines legislation (the Commission has launched public consultation on the following two implementing measures: the unique identifier and the assessment of the GMP status for active substances from non-EU countries).
Maltese: • L-implimentazzjoni tal-leġiżlazzjoni dwar il-mediċini ffalsifikati (il-Kummissjoni nediet konsultazzjoni pubblika dwar iż-żewġ miżuri implimentattivi li ġejjin: l-identifikatur uniku u lvalutazzjoni tal-istatus tal-GMP għas-sustanzi attivi mill-pajjiżi li m'humiex fl-UE).
English: The amendments concern the following areas: inspections, plasma master files, certificates for medicinal products, type II variations to MUMS marketing authorisations for non-food-producing species, and core dossiers for medicinal products to be used in a human pandemic situation.
Maltese: Lemendi jirrigwardaw l-oqsma li ġejjin: spezzjonijiet, fajls prinċipali tal-plażma, ċertifikati għal prodotti mediċinali, varjazzjonijiet tat-tip II għall-awtorizzazzjonijiet għat-tqegħid fis-suq tal-MUMS għall-ispeċji li ma jipproduċux ikel, u dokumenti ewlenin għal prodotti mediċinali li għandhom jintużaw f'sitwazzjoni ta' pandemija fost il-bnedmin.
English: Significant improvements have been made in the area of management of potential conflicts of interests of experts and staff members.
Maltese: Sar titjib sinifikanti fil-qasam tal-ġestjoni ta' kunflitti ta' interess potenzjali talesperti u tal-membri tal-persunal.
English: Members expressed regret and dissatisfaction regarding the delay in the nomination process.
Maltese: Il-membri esprimew id-dispjaċir u n-nuqqas ta' sodisfazzjon tagħhom rigward id-dewmien fil-proċess tannominazzjoni.
English: [EMA/MB/143451/2011] The Board adopted the Agency's budget and the establishment plan for 2012.
Maltese: [EMA/MB/143451/2011] Il-Bord adotta l-baġit tal-Aġenzija u l-pjan ta' stabbiliment għall-2012.
English: In particular, the Board decided to defer the election process for the Vice-chair of the Board and the Chair of the Management Board Telematics Committee (MBTC) until after the civil society nominations have been made, which is anticipated in June 2012.
Maltese: B'mod partikolari, il-Bord iddeċieda li jiddifferixxi l-proċess elettorali għall-Viċi President tal-Bord u l-President tal-Kumitat tat-Telematika tal-Bord ta' Tmexxija (Management Board Telematics Committee - MBTC) sa wara li jkunu saru n-nominazzjonijiet tas-soċjetà ċivili, li huma mistennija li jsiru f'Ġunju 2012.
English: [EMA/MB/643417/2011] The Management Board noted the revised staff policy plan, in line with the reduced staffing and budget compared to the 2012 preliminary draft budget.
Maltese: [EMA/MB/643417/2011] Il-Bord ta' Tmexxija ħa nota tal-pjan rivedut ta' politika tal-persunal, skont ittnaqqis fil-persunal u fil-baġit meta mqabbel mal-abbozz tal-baġit preliminari għall-2012.
English: Andreas had been in charge of the Agency as acting Executive Director since January 2011 and has demonstrated his leadership, personal judgement and dedication by leading the organisation in a complex environment throughout 2011.
Maltese: Andreas kien responsabbli mill-Aġenzija bħala Direttur Eżekuttiv temporanju minn Jannar 2011 u wera l-ħila ta' tmexxija, tal-ġudizzju personali u d-dedikazzjoni tiegħu billi mexxa lill-organizazzjoni f'ambjent kumpless matul l-2011.
English: The Board noted the letter from Paola Testori, Director-General of the DG for Health and Consumers, on the subject.
Maltese: Il-Bord ħa nota tal-ittra ta' Paola Testori, Direttur Ġenerali tad-DĠ għas-Saħħa u l-Konsumaturi, dwar is-suġġett.
English: However, it was explained that the definitions in this policy mirror those adopted for the policy on conflicts of interests of experts, and it would be appropriate to keep both policies in line.
Maltese: Madankollu, kien spjegat li d-definizzjonijiet f'din il-politika jirriflettu dawk adottati fil-politika dwar il-kunflitti ta' interess tal-esperti, u jkun xieraq li ż-żewġ politiki jinżammu konformi.
English: List of written procedures during the period from 15 September 2011 to 30 November 2011
Maltese: Lista ta' proċeduri bil-miktub matul il-perjodu ta' bejn il15 ta' Settembru 2011 u t-30 ta' Novembru 2011
English: The report also showed an increase in requests for data from EudraVigilance, a significant increase of Member States working with the EudraVigilance Data Analysis System, and improved compliance with the legal timeframes for the transmission of individual case safety reports.
Maltese: Ir-rapport wera wkoll żieda fit-talbiet għal dejta mill-EudraViġilanza, żieda konsiderevoli ta' Stati Membri li jaħdmu bis-Sistema ta' Analiżi tad-Dejta tal-EudraViġilanza, u titjib fil-konformità malperjodi ta' żmien legali għat-trażmissjoni ta' rapporti ta' sigurtà tal-każijiet individwali.
English: The European Commission has decided to take over the responsibilities for SoHO activities.
Maltese: Il-Kummissjoni Ewropea ddeċidiet li tieħu f'idejha r-responsabbiltajiet għall-attivitajiet tas-SoHO.
English: The Chair of the HMA management group provided an update on a number of items, including the following:
Maltese: Kumpens finanzjarju għall-parteċipazzjoni tal-Istati Membri fil-verifika lingwistika tal-informazzjoni relatata malprodott:
English: The European Commission reminded the Board of the fact that the EU contribution to the Agency's budget is a balancing contribution.
Maltese: It-tnaqqis huwa dovut l-aktar għal kontribuzzjoni aktar baxxa mill-UE minn kemm ġie mitlub.
English: In addition to his responsibilities as Deputy Executive Director, Andreas will continue in his position as Head of Administration Unit.
Maltese: Minbarra r-responsabbiltajiet tiegħu bħala Deputat Direttur Eżekuttiv, Andreas ser ikompli fil-kariga tiegħu bħala Kap tat-Taqsima tal-Amministrazzjoni.
English: New topic coordinators were requested.
Maltese: Intalbu koordinaturi tas-suġġetti ġodda.
English: Minutes of the 74th meeting of the Management Board
Maltese: Minuti tal-74 laqgħa tal-Bord ta' Tmexxija
English: 300 mg Concentrate for solution for infusion
Maltese: 300 mg Konċentrat għal soluzzjoni għallinfużjoni
English: Oral suspension Oral use bottle (glass)
Maltese: Suspensjoni orali flixkun (ħġieġ)
English: 105 ml
Maltese: 105 ml flixkun 1
English: Ethinylestradiol-Drospirenone 24+4 is a combined oral contraceptive (COC) and contains ethinylestradiol 20 µg and the progestogen drospirenone 3 mg (EE/DRSP).
Maltese: Ethinylestradiol-Drospirenone 24+4 huwa kontraċettiv orali kkombinat (combined oral contraceptiveCOC) u fih 20 µg ethinylestradiol u 3 mg proġestoġen drospirenone (EE/DRSP).
English: Venous thromboembolic events (VTEs)
Maltese: Effetti Tromboemboliċi fil-vini (VTEs)
English: After six months of treatment, in comparison with placebo, EE/DRSP showed a statistically and clinically significant reduction of 15.6% (49.3% versus 33.7%) in inflammatory lesions, 18.5% (40.6% versus 22.1%) in non-inflammatory lesions, and 16.5% (44.6% versus 28.1%) in total lesion counts.
Maltese: 6% (49.3% kontra 33.7%) fil-feriti infjammati, 18.5% (40.6% kontra 22.1%) fil-feriti mhux infjammati, u 16.5% (44.6% kontra 28.1%) fl-għadd totali ta' feriti.
English: The classification of acne severity is from mild, moderate, moderately severe to severe depending on the presence of the lesions.
Maltese: Il-klassifikazzjoni tas-severità tal-akne tvarja minn ħafifa, moderata, moderatament severa għal severa skont kemm ikun hemm feriti preżenti.
English: At least four patho-physiologic events take place within acne-infected hair follicles: i) androgenmediated stimulation of sebaceous gland activity, ii) abnormal keratinisation leading to follicular plugging (comedo forming), iii) proliferation of the bacterium Proprioni-bacterium acnes (P. acnes) within the follicle, iv) inflammation.
Maltese: Mill-inqas iseħħu erba' effetti patofiżjoloġiċi fil-follikuli tax-xagħar infettati bl-akne: i) stimulazzjoni medjata mill-androġeni ta' attività tal-glandoli sebaċeji, ii) keratinizzazzjoni anormali li twassal għallimblukkar follikulari (l-iffurmar ta' comedo), iii) tixrid tal-batterju Proprioni-bacterium acnes (P. acnes) fil-follikulu, iv) infjammazzjoni.
English: Efficacy
Maltese: Effikaċja
English: The mean difference observed in total lesion count reduction is of 16% between EE/DRSP and placebo.
Maltese: Id-differenza medja osservata fit-tnaqqis totali tal-għadd ta' feriti hija ta' 16% bejn EE/DRSP u l-plaċebo.
English: The overall efficacy assessment of EE/DRSP as a treatment for moderate acne vulgaris in reproductive age women observed during studies A25083 and A25152 demonstrates statistically significant responses to treatment with EE/DRSP as compared to placebo in all four primary efficacy variables (inflammatory lesion, non-inflammatory lesion, and total lesion counts, and women with a ‘clear' or ‘almost clear' rating on the ISGA scale) and the majority of secondary efficacy variables (papules, pustules, closed and open comedones).
Maltese: L-evalwazzjoni globali tal-effikaċja ta' EE/DRSP bħala kura għall-akne vulgaris moderata f'nisa ta' età riproduttiva osservata waqt l-istudji A25083 u A25152 turi reazzjonijiet statistikament sinifikanti għallkura b'EE/DRSP meta mqabbel mal-plaċebo f'kull wieħed mill-erba' varjabbli ewlenin tal-effikaċja (feriti infjammati, feriti mhux infjammati, u għadd totali ta' feriti, u nisa bi grad ta' ‘ħielsa' jew ‘kważi ħielsa' fuq l-iskala ISGA) u fil-parti l-kbira tal-vajrabbli sekondarji tal-effikaċja (papuli, infafet, comedones magħluqin u miftuħin).
English: The mean age at presentation for treatment is 24 years, with 10% of treatment visits taking place when patients are between the ages of 35 and 44 years.
Maltese: L-età medja ta' dawk li jfittxu kura hija 24 sena, b'10% tal-viżti għall-kura jseħħu meta l-pazjenti jkollhom bejn 35 u 44 sena.
English: The overall efficacy of EE/DRSP as a treatment for moderate acne vulgaris in reproductive age women was shown in the two placebo-controlled A25083 and A25152 studies.
Maltese: L-effikaċja globali ta' EE/DRSP bħala kura għall-akne vulgaris moderata f'nisa f'età riproduttiva ntweriet f'żewġ studji A25083 u A25152 ikkontrollati minn plaċebo.
English: The Marketing Authorisation Holder (MAH), Bayer B.V. submitted a type II variation via mutual recognition procedure for Ethinylestradiol-Drospirenone 24+4 and associated names (NL/H/1269, 1270/01/II/006) on 26 January 2009, to request an extension of the indication to include: “Oral contraception for women with moderate acne vulgaris.
Maltese: Fis-26 ta' Jannar 2009, Sid l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH), Bayer B.V. ippreżenta varjazzjoni tat-tip II permezz ta' proċedura ta' rikonoxximent reċiproku għal EthinylestradiolDrospirenone 24+4 u ismijiet assoċjati (NL/H/1269, 1270/01/II/006), sabiex jitlob estensjoni talindikazzjoni b'mod li tkun tinkludi: “Kontraċezzjoni orali għal nisa b'akne vulgaris moderata.
English: a) the known greater risk of venous thromboembolic events (VTE) for DRSP-COCs in comparison with levonorgestrel (LNG)-COCs;
Maltese: a) ir-riskju akbar magħruf ta' effetti tromboemboliċi fil-vini (VTE) għall-kontraċettivi orali kkombinati li fihom DRSP meta mqabbla mal-kontraċettivi orali kkombinati li fihom levonorgestrel (LNG);
English: On 28 June 2011 and 29 June 2011 Italy and Sweden respectively, triggered a referral under Article 6(12) of Commission Regulation EC No 1084/2003.
Maltese: Fit-28 ta' Ġunju 2011 u fid-29 ta' Ġunju 2011 l-Italja u l-Isvezja rispettivament, bdew referenza taħt lArtikolu 6(12) tar-Regolament tal-Kummissjoni KE Nru 1084/2003.
English: The treatment with EE/DRSP is associated with venous thromboembolic events (VTE) and with breast cancer risks.
Maltese: Il-kura b'EE/DRSP hija assoċjata ma' riskji ta' effetti tromboemboliċi fil-vini (VTE) u ta' kanċer tas-sider.