FrancophonIA/ELRC3.0 huggingface dataset:
English: These projects have been agreed as being EudraNet, EudraVigilance, EudraPharm, electronic submissions, clinical trials and good manufacturing practice databases.
Maltese: Dawn il-proġetti ġew maqbula li huma d-databases tal-Eudranet, il-Eudravigilance, il-EudraPharm, il-preżentazzjonijiet elettroniċi, il-provi kliniċi u il-prattika tajba ta' manifattura.
English: It will continue to implement the policy on micro, small and medium-sized enterprises (SMEs), which are often innovative companies working in the field of new technologies and emerging therapies; will continue to provide high-quality scientific advice to companies developing medicinal products; will support the development of orphan medicinal products; and will actively participate in the Innovative Medicines Initiative.
Maltese: Hija ser tkompli timplimenta lpolitika għall-intrapriżi mikro, żgħar u ta' daqs medju (SMEs), li ta' spiss huma kumpanniji innovattivi li jaħdmu fil-qasam ta' teknoloġiji ġodda u terapiji ġodda ; ser tkompli tipprovdi parir xjentifiku ta' kwalità għolja lil kumpanniji li qed jiżviluppaw prodotti mediċinali ; ser tkompli tappoġġa l-iżvilupp ta' prodotti mediċinali ltiema ; u ser tipparteċipa fl-Inizjattiva għal Mediċini Innovattivi.
English: Accounting
Maltese: Kontabbiltà
English: EU Telematics Controlled Terms (2nd Proof of Concept concluded)
Maltese: (It-tieni Prova ta' Kunċett konkluż)
English: For enquiries concerning PMF certificates
Maltese: Għal talbiet dwar ċertifikati għal PMF
English: SME office contact point:
Maltese: Il-punt ta' kuntatt ta' l-uffiċċju ta' l-SME:
English: The EMEA will continue its initiatives aimed at improving the availability of veterinary medicines for minor uses and minor species.
Maltese: L-EMEA ser tkompli l-inizjattivi tagħha mmirati biex itejbu d-disponibbiltà ta' mediċini veterinarji għal użu minuri u speċi minuri.
English: − Implement the new regulation on medicinal products for paediatric use, including the establishment of a new Paediatric Committee, delivering opinions and decisions on paediatric investigation plans and waivers, and providing information on paediatric clinical trials.
Maltese: − L-implimentazzjoni tar-regolament il-ġdid dwar prodotti mediċinali għal użu pedjatriku, inkluż ittwaqqif ta' Kumitat Pedjatriku ġdid, it-twassil ta' fehmiet u deċiżjonijiet dwar pjanijiet ta' investigazzjonijiet pedjatriċi u rinunzji, u l-forniment ta' informazzjoni dwar provi kliniċi pedjatriċi.
English: Type-I variation applications Type-II variation applications Line-extension applications
Maltese: Aplikazzjonijiet tal-varjazzjoni Tip-II
English: Other
Maltese: x
English: MRL extrapolations
Maltese: 2.8 Mediċini għat-tfal
English: EudraCT (In production)
Maltese: EudraCT (Qed tiġi prodotta)
English: The Agency will receive entirely new responsibilities in the field of paediatric medicines.
Maltese: L-Aġenzija ser tirċievi responsabbilitajiet kompletament ġodda fil-qasam tal-mediċini pedjatriċi.
English: − Fulfil the Agency's obligations with regard to coordinating the supervision of veterinary medicines once authorised, through effective implementation of pharmacovigilance as well as through the dissemination of information on adverse drug reactions.
Maltese: − Jiġu mwettqin l-obbligi ta' l-Aġenzija fir-rigward tal-koordinazzjoni tas-superviżjoni ta' mediċini veterinarji ladarba jiġu awtorizzati, permezz ta' implimentazzjoni effettiva ta' farmakoviġilanza kif ukoll permezz tat-tixrid ta' informazzjoni dwar reazzjonjiet mhux mixtieqa għal mediċini.
English: To respond to the increasing number of meetings, and to improve the meetings-organisation workflow and procedures, the Agency will focus on two aspects: streamlining the management of meetings and providing alternative meeting solutions.
Maltese: B'reazzjoni għan-numru li qed jiżdied ta' laqgħat, u biex jittejbu l-proċeduri u l-workflow ta' lorganizzazzjoni ta' laqgħat, l-Aġenzija ser tiffoka fuq żewġ aspetti: titjib fl-effiċjenza tal-ġestjoni ta' laqgħat u l-forniment ta' soluzzjonijiet alternattivi ta' laqgħat.
English: Quarterly releases are anticipated, implementing increases in functionality in the areas of search, use by specific audiences, data entry, interaction with other systems and use of controlled vocabularies.
Maltese: Kull tliet xhur huma antiċipati publikazzjonijiet, li jimplimentaw żidiet fil-funzjonalità fl-oqsma ta' riċerka, l-użu ta' udjenzi speċifiċi, dħul ta' data, interazzjoni mas-sistemi l-oħrajn u l-użu ta' vokabolarji kontrollati.
English: MRL ext./mod.
Maltese: Applikazzjonijiet ta' l-MRL godda Applikazzjonijiet est./mod.
English: It will also address aspects relating to data quality and stakeholders' compliance with expedited reporting timelines.
Maltese: Hija ser tindirizza wkoll l-aspetti relatati mal-kwalità ta' data u l-konformità tal-partijiet interessati ma' perijodi mgħaġġla ta' rapportaġġ.
English: With regard to alternative meeting solutions, the Agency will work to extend videoconferencing and broadcasting of meetings to national competent authorities and EMEA experts.
Maltese: Fir-rigward ta' soluzzjonijiet alternattivi ta' laqgħat, l-Aġenzija ser taħdem biex testendi lvidjokonferenzi u x-xandir ta' laqgħat għal awtoritajiet nazzjonali kompetenti u l-esperti ta' l-EMEA.
English: The latter will help to maintain and improve the quality of translations of non-product information documents.
Maltese: Din ta' l-aħħar ser tgħin tmantni u ttejjeb il-kwalità ta' traduzzjonijiet ta' dokumenti ta' informazzjoni li mhumiex relatati ma prodotti.
English: 2.10 Scientific committees, working parties and scientific advisory groups
Maltese: 2.10 Kumitati Xjentifiċi, gruppi ta' ħidma u gruppi xjentifiċi konsultattivi
English: In addition to handling notifications, the Agency plans to review and update its guidance on parallel distribution to improve the efficiency of parallel-distribution notification processes, and will publish parallel-distribution notifications issued by the EMEA on its website.
Maltese: Barra n-notifiki operattivi, l-Aġenzija tippjana li tirrevedi u taġġorna l-gwida tagħha dwar id-distribuzzjoni parallela biex ittejjeb l-effiċjenza ta' proċessi ta' notifiki ta' distribuzzjoni paralleli, u ser tippublika notifiki ta' distribuzzjoni parallela maħruġa mill-EMEA fil-website tagħha.
English: − Strengthen cooperation on pharmacovigilance, EU telematics, scientific advice, support to SMEs and communication;
Maltese: − It-tisħiħ tal-kooperazzjoni fil-qasam tal-farmakoviġilanza, il-telematika ta' l-UE, l-pariri xjentifiċi, l-appoġġ għall-SMEs u l-komunikazzjoni;
English: Periodic safety-update reports (PSURs).
Maltese: Rapporti perjodiċi dwar l-aġġornar ta' sigurtà (PSURs).
English: Arbitration, Community referrals and opinions on scientific matters (Human medicines)
Maltese: Arbitraġġ, riferenzi Komunitarji u fehmiet dwar materji xjentifiċI (Mediċini għall-bnidem)
English: Panos TSINTIS
Maltese: Bini/Tagħmir
English: This will be done through various initiatives, which will also include development and maintenance of a scientific memory database.
Maltese: Dan ser isir permezz ta' inizjattivi varji, li ser jinkludu wkoll l-iżvilupp u l-manutenzjoni ta' database ta' memorja xjentifika.
English: New MRL applications
Maltese: Klassifikar ta' prodotti medicinali ltiema
English: A fifth scientific committee, the Paediatric Committee, will be established in the second quarter of 2007.
Maltese: Il-ħames kumitat xjentifiku, il-Kumitat Pedjatriku, ser jiġi mwaqqaf fit-tieni kwart ta' l-2007.
English: Over 4 000 experts are used by the EMEA in its scientific evaluation work.
Maltese: 'Il fuq minn 4000 espert huma użati mill-EMEA fil-ħidma ta' valutazzjoni xjentifika tagħha.
English: New medicinal products (non-orphan)
Maltese: Prodotti medicinali godda (mhux ltiema)
English: 2 Committee for Medicinal Products for Human Use (CHMP).
Maltese: 2 Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP).
English: Work will also commence in the area of paediatric pharmacovigilance.
Maltese: Ser tibda ħidma fil-qasam tal-farmakoviġilanza pedjatrika.
English: These projects will be complemented by work to enhance the electronic document management system (Managing Meeting Documents, eCollaboration and setting up workflows), which will rationalise processes linked to managing meeting-related documentation.
Maltese: Dawn il-proġetti ser ikunu komplementati bil-ħidma biex tiġi msaħħa s-sistema elettronika ta' ġestjoni tad-dokumenti (Ġestjoni ta' Dokumenti ta' Laqgħat, e-Kollaborazzjoni u l-iżvilupp ta' workflows), li ser jirrazzjonalizzaw il-proċessi marbutin mal-ġestjoni ta' dokumentazzjoni relatata mal-laqgħat.
English: The Agency will complete the development of the communication and transparency strategy and begin its implementation during 2007.
Maltese: L-Aġenzija ser tkompli tiżviluppa l-istrateġija ta' komunikazzjoni u trasparenza u tibda limplimentazzjoni tagħha matul l-2007.
English: The Agency expects that the number of applications in the post-authorisation area of veterinary medicines will remain largely unchanged.
Maltese: L-Aġenzija tistenna li n-numru ta' applikazzjonijiet fil-qasam ta' wara l-awtorizzazzjoni ta' mediċini veterinarji ser tibqa' ġeneralment mhux mittiefsa.
English: Warehouse
Maltese: Drittijiet
English: This will enable the Agency to ensure the provision of reliable and robust IT services to its staff, delegates and all users of pan-European systems.
Maltese: Dan ser jippermetti l-Aġenzija li tiżgura d-dispożizzjoni ta' servizzi ta' l-IT li wieħed jista' joqgħod fuqhom u robusti għall-persunal tagħha, id-delegati u l-utenti kollha tas-sistemi pan-Ewropej.
English: Work will be done to progress a risk-based approach to the selection of products and parameters for testing in view of generic applications and advances in technology (Process Analytical Technology), and the Agency will review a ‘one-laboratory testing scheme' concept and assess its possible introduction for biological products.
Maltese: Il-ħidma ser issir biex isir progress f'approċċ ibbażat fuq ir-riskju għall-għażla tal-prodotti u l-parametri għall-ittestjar fid-dawl ta' applikazzjonijiet ġeneriċi u avvanzi fit-teknoloġija (Teknoloġija Analitika tal-Proċessi), u l-Aġenzija ser tirrevedi lkunċett ‘tas-skema ta' ttestjar ta' laboratorju uniku' u ser tivvaluta l-possibbiltà li tiġi introdotta għal prodotti bioloġiċi.
English: This intensification must be supported by improved cost-effectiveness of the Agency's operations and further improvement of its quality assurance systems.
Maltese: L-implimentazzjoni ta' servizzi avvanzati ta' ġestjoni ta' network u ta' prestazzjoni.
English: To better prepare itself and the network for the advent of new therapies and technologies, the Agency will promote early dialogue with sponsors of potential applications for advanced therapies and emerging products and technologies.
Maltese: Biex tipprepara aħjar lilha nnifisha u n-network għall-wasla ta' terapiji u teknoloġiji ġodda, l-Aġenzija ser tippromwovi djalogu bikri ma' l-isponsors ta' applikazzjonijiet potenzjali għal terapiji avvanzati u prodotti u teknoloġiji ġodda.
English: 3.3 Sampling and testing
Maltese: 3.3 Teħid ta' kampjuni u ttestjar
English: Streamlining of meeting management will be achieved by enhancing the Agency's Meeting Management System to include a tracking system for hotel and travel details and, via the EMEA website, online booking facilities for delegates.
Maltese: It-titjib fl-effiċjenza tal-ġestjoni ta' laqgħat ser tinkiseb bit-tisħiħ tas-Sistema ta' Ġestjoni ta' Lagħat ta' l-Aġenzija li tinkludi sistema biex jiġu segwiti dettalji dwar lukandi u vjaġġar u, permezz tal-website ta' l-EMEA, faċilitajiet għal reservazzjonijiet online għad-delegati.
English: This is a result of recognition and appreciation by potential applicants of improvements to the veterinary scientific advice procedure, as well as growing confidence in the industry through experience with the procedure.
Maltese: Dan huwa riżultat ta' l-għarfien u l-apprezzament minn applikanti potenzjali għal titjib filproċedura għal parir xjentifiku veterinarju, kif ukoll bħala kunfidenza li qed tikber fl-industrija permezz ta' l-esperjenza bil-proċedura.
English: Occupied as per
Maltese: Attivitajiet ta' Appoġġ
English: The Agency expects to complete the implementation of the full scope of the GMP Annex with EC-Japan MRA and maintenance arrangements.
Maltese: Barra minn hekk, hemm sett ta' servizzi orizzontali li huma meħtieġa biex jappoġġaw l-implimentazzjoni tas-sistemi msemmijin.
English: Veterinary marketing authorisation procedures Safety of veterinary medicines
Maltese: Proċeduri veterinarji ta' awtorizzazzjoni għal tqegħid fis-suq Sigurtà ta' mediċini veterinarji
English: Type-IA variations
Maltese: Numru ta' Spezzjonijiet
English: 2.4 Establishment of maximum residue limits
Maltese: L-ifissar ta' limiti massimi ta' residwi
English: The number of type-I and II variations will change in line with the growing number of centrally authorised products.
Maltese: In-numru tal-varjazzjonijiet tat-tip-I u II ser jinbidlu skond in-numru li qed jikber ta' prodotti awtorizzati ċentralment.
English: The increase also takes into account activities postponed from 2006, as well as participation of representatives of candidate countries in meetings, training courses and conferences.
Maltese: Iż-żieda tieħu kont ukoll ta' l-attivitajiet postposti mill-2006, kif ukoll parteċipazzjoni tar-rappreżentanti talpajjiżi kandidati fil-laqgħat, korsijiet ta' taħriġ u konferenzi.
English: − Continue supporting the European Commission through the stages leading to the new regulation on advanced therapies; participate in the work of the Innovative Medicines Initiative for human medicines, the European Technology Platform for Global Animal Health for veterinary medicines, and in other international initiatives to improve drug development.
Maltese: − Appoġġ kontinwu għall-Kummissjoni Ewropea permezz ta' l-istadji li jwasslu għar-regolament ġdid dwar it-terapiji avvanzati; il-parteċipazzjoni fil-ħidma ta' l-Inizjattiva għal Mediċini Innovattivi għal mediċini għall-użu tal-bniedem, il-Pjattaforma tat-Teknoloġija Ewropea għasSaħħa Globali ta' l-Annimali għal mediċini veterinarji, u f'inizjattivi internazzjonali oħrajn li jtejbu l-iżvilupp tal-mediċini.
English: Additional priorities in 2007 will include:
Maltese: Prijoritajiet addizzjonali fl-2007 ser jinkludu:
English: Despite initiatives taken by the CVMP1 to facilitate the authorisation of products for minor uses and minor species, the number of associated extensions and modifications has remained stable over the last years - a situation likely to continue in 2007, with 5 applications being predicted.
Maltese: Minkejja l-inizjattivi meħudin mis-CVMP1 biex tiġi ffaċilitata l awtorizzazzjoni ta' prodotti għal użi minuri u speċji minuri, in-numru ta' estensjonijiet u modifiki assoċjati baqgħu stabbli matul dawn l-aħħar snin - sitwazzjoni li x'aktarx tissokta fl-2007, b'5 applikazzjonijiet previsti.
English: Annex 3 Revenue and expenditure overview 2005-2007
Maltese: Ħarsa ġenerali lejn id-dħul u l-infiq 2005-2007
English: To respond to the growing number of meetings and visiting delegates, and to rationalise resource use, the Agency will progress the development of integrated videoconferencing and other virtual meetings solutions, in line with specific meeting requirements.
Maltese: Bi tweġiba għan-numru li qed jikber ta' laqgħat u żjarat ta' delegati, u biex ikun hemm użu ta' risorsi razzjonali, l-Aġenzija ser tagħmel progress fl-iżvilupp tal-vidjokonferenzi integrati u soluzzjonijiet ta' laqgħat virtwali oħrajn, skond il-ħtiġiet tal-laqgħa speċifika.
English: Together with the Member States, the Agency will continue to work on encouraging a reporting culture on pharmacovigilance issues.
Maltese: Flimkien ma' l-Istati Membri, l-Aġenzija ser tkompli taħdem biex tħeġġeġ kultura ta' rapportaġġ dwar kwistjonijiet ta' farmakoviġilanza.
English: Incentives are provided because such medicines might, for economic reasons, not otherwise be developed.
Maltese: Inċentivi huma pprovduti peress li tali mediċini jistgħu, għal raġunijiet ekonomiċi, ma jiġux madankollu żviluppati.
English: In order to ensure that scientific issues are fully discussed prior to submission, and thus to avoid premature applications in the veterinary area, the Agency will hold pre-submission meetings involving the rapporteur, corapporteur and necessary experts.
Maltese: Sabiex jiġi żgurat li kwistjonijiet xjentifiċi jiġu diskussi bis-sħiħ qabel il-preżentazzjoni, u b'hekk jiġu evitati applikazzjonijiet prematuri fil-qasam veterinarju, l-Aġenzija ser iżżomm laqgħat qabel ilpreżentazzjoni li jinvolvu r-relatur, il-ko-relatur u l-esperti meħtieġa.
English: The Agency is active in the field of advanced therapy medicinal products such as gene therapy, somatic cell-therapy and human tissue-engineered products.
Maltese: L-Aġenzija hija attiva fil-qasam tal-prodotti mediċinali ta' terapija avvanzata bħat-terapija tal-ġeni, itterapija taċ-ċelluli somatiċi u l-prodotti li jirriżultaw minn inġinerija tat-tessut uman.
English: The procedures include: pre-authorisation procedure for risk-management plans, conditional marketing authorisation, accelerated assessment, procedures for generic and similar biological products, procedures for compassionate use and for products intended for non-EU markets.
Maltese: Il-proċeduri jinkludu: proċedura ta' qabel l-awtorizzazzjoni għal pjanijiet għall-ġestjoni tarriskji, awtorizzazzjoni għal tqegħid fis-suq kondizzjonata, valutazzjoni mgħaġġla, proċeduri għal prodotti ġeneriċi u bioloġiċi simili, proċeduri għal użu b' kompassjoni u għal prodotti intiżi għal swieq li mhumiex fl-UE.
English: Discussions
Maltese: Diskussjonijiet
English: Category 2 medicinal products
Maltese: Prodotti mediċinali tal-kategorija 2
English: Category 1 medicinal products
Maltese: Prodotti mediċinali tal-kategorija 1
English: Neo Balkanika (for Nebivolol);
Maltese: Neo Balkanika (għal Nebivolol);
English: Grounds for CHMP Opinion
Maltese: Raġunijiet għall-opinjoni tas-CHMP
English: Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma and Labesfal Genéricos (for Alendronate);
Maltese: Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma u Labesfal Genéricos (għal Alendronate);
English: Dr. Reddy's Laboratories (UK) Ltd and betapharm Arzneimittel GmbH (for Dipyridamole and Levetiracetam);
Maltese: Dr. Reddy's Laboratories (UK) Ltd u betapharm Arzneimittel GmbH (għal Dipyridamole u Levetiracetam);
English: Genericon Pharma Austria (for Nebivolol).
Maltese: Genericon Pharma Austria (għal Nebivolol).
English: The French Agency on medicinal products (ANSM) conducted an inspection on 19-23 May 2014 (inspection reference GCP-141001-FR) at GVK Biosciences Private Limited, Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, India.
Maltese: L-Aġenzija Franċi¿a dwar il-prodotti mediċinali (ANSM) fid-19-23 ta' Mejju 2014 wettqet spezzjoni (referenza tal-ispezzjoni GCP-141001-FR) għand GVK Biosciences Private Limited, kumpless kummerċjali ta' Swarna Jayanthi, Ameerpet, Hyderabad 500 038, l-Indja.
English: Heumann Pharma GmbH & co. Generica KG, and Torrent Pharma GmbH / Torrent Pharma SRL (for Irbesartan/hydrochlorothiazide and Irbesartan);
Maltese: Generica KG, u Torrent Pharma GmbH / Torrent Pharma SRL (għal Irbesartan hydrochlorothiazide u Irbesartan);
English: • Re-examination request for Nebivolol Genericon Pharma Austria
Maltese: • Talba għal rie¿aminazzjoni għal Nebivolol Genericon Pharma Austria
English: BE established versus non-EU RMP for Irbesartan/hydrochlorothiazide: For the EU MA dossier for Irbesartan/hydrochlorothiazide 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg the following bioequivalence study has been performed: bioequivalence study for Irbesartan + Hydrochlorothiazide Film-coated Tablets using 300/25mg strength against EU reference product COAPROVEL 300/25mg Filmcoated Tablets.
Maltese: Għad-dossier tal-MA tal-UE għal Irbesartan/hydrochlorothiazide 150 mg/12.5 mg, 300 mg/12.5 mg u 300 mg/25 mg, twettaq l-istudju ta' bijoekwivalenza li ġej: studju ta' bijoekwivalenza għal Irbesartan + Hydrochlorothiazide Pilloli miksijin b'rita li u¿a l-qawwa ta' 300/25mg kontra l-prodott ta' referenza talUE, COAPROVEL 300/25mg Pilloli miksijin b'rita.
English: • For medicinal products (Annex IA) for which other bioequivalence studies than the one(s) performed at GVK Biosciences Hyderabad site or claims that the medicinal products fulfil the criteria for a Biopharmaceutics Classification System (BCS)-based biowaiver as described in Appendix III of the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98) were submitted, assessed and considered positive by the CHMP (i.e. medicinal products containing Bendroflumetiazid, Bosentan, Fexofenadine, Lansoprazole, Levetiracetam, Levocetirizine, Metoclopramide, Nebivolol and Venlafaxine), the CHMP is of the opinion that the bioequivalence has been established.
Maltese: • Għall-prodotti mediċinali (Anness IA) li għalihom kienu ppre¿entati, valutati u kkunsidrati bħala po¿ittivi mis-CHMP studji oħra ta' bijoekwivalenza għajr dak/dawk imwettaq/imwettqa fis-sit ta' GVK Biosciences Hyderabad jew affermazzjonijiet li l-prodotti mediċinali jissodisfaw il-kriterji għal bijorinunzja bba¿ata fuq is-Sistema ta' Klassifikazzjoni tal-Bijofarmaċewtiċi (BCS) kif deskritta fl-Appendiċi III tal-Linja gwida dwar l-investigazzjoni tal-bijoekwivalenza (CPMP/EWP/QWP/1401/98) (jiġifieri prodotti mediċinali li fihom Bendroflumetiazid, Bosentan, Fexofenadine, Lansoprazole, Levetiracetam, Levocetirizine, Metoclopramide, Nebivolol u Venlafaxine), is-CHMP huwa tal-opinjoni li l-bijoekwivalenza kienet stabbilita.
English: • Composition differences - the test product contains critical excipients that may affect the pharmacokinetics profile of the medicinal product (absorption).
Maltese: • Differenzi fil-kompo¿izzjoni - il-prodott tat-test fih eċċipjenti importanti li jistgħu jaffettwaw il profil farmakokinetiku tal-prodott mediċinali (assorbiment).
English: The clinical phase was conducted at GVK Bio; the bioanalytical, pharmacokinetic and statistical phases of the study were carried out by another CRO.
Maltese: Il-fa¿i klinika twettqet għand GVK Bio; il-fa¿ijiet bijoanalitiċi, farmakokinetiċi u statistiċi tal-istudju twettqu minn CRO oħra.
English: As stated in Article 62(1) paragraph 4 of Regulation (EC) No 726/2004 and Article 32(4) paragraph 3 of Directive 2001/83/EC, “the re-examination procedure may deal only with the points of the opinion initially identified by the applicant/MAH and may be based only on the scientific data available when the Committee adopted the initial opinion.” Therefore these scientific data can not be considered during the re-examination procedure.
Maltese: Kif iddikjarat fl-Artikolu 62(1) paragrafu 4 tar-Regolament (KE) Nru 726/2004 u l-Artikolu 32(4) paragrafu 3 tad-Direttiva 2001/83/KE, “il-proċedura ta' rie¿aminazzjoni għandha tirrelata biss ma' punti mill-opinjoni identifikati inizjalment mill-applikant u jistgħu jkunu bba¿ati biss fuq id-data xjentifika disponibbli meta l-Kumitat adotta l-opinjoni inizjali.” Għalhekk din id-data xjentifika ma tistax titqies matul il-proċedura ta' rie¿aminazzjoni.
English: • Request for re-examination for Irbesartan and Irbesartan/hydrochlorothiazide:
Maltese: • Talba għal rie¿aminazzjoni għal Irbesartan u Irbesartan hydrochlorothiazide:
English: • The Committee concluded for marketing authorisations of medicinal products of Annex IA containing Bendroflumetiazid, Bosentan, Fexofenadine, Lansoprazole, Levetiracetam, Levocetirizine, Metoclopramide, Nebivolol and Venlafaxine that the benefit risk balance is positive in the approved indications.
Maltese: IA li fihom Bendroflumetiazid, Bosentan, Fexofenadine, Lansoprazole, Levetiracetam, Levocetirizine, Metoclopramide, Nebivolol u Venlafaxine, il-Kumitat ikkonkluda li l-bilanċ bejn il-benefiċċju u rriskju huwa po¿ittiv fl-indikazzjonijiet approvati.
English: The full bioanalytical report is missing.
Maltese: Ir-rapport bijoanalitiku sħiħ huwa nieqes.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP recommends:
Maltese: Għalhekk, skont l-Artikoli 31 u 32 tad-Direttiva 2001/83/KE, is-CHMP jirrakkomanda: