FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vivanza on 4 March 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vivanza fl-4 ta' Marzu 2003.
English: This is a summary of the European public assessment report (EPAR) for Vivanza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vivanza.
English: For Vivanza to be effective, sexual stimulation is required.
Maltese: Biex Vivanza jkun effettiv irid ikun hemm stimulazzjoni sesswali.
English: Why has Vivanza been approved?
Maltese: Għaliex ġie approvat Vivanza?
English: Vivanza must not be taken with some medicines, such as ketoconazole and itraconazole (to treat fungal infections) in men over 75 years, or medicines called ‘HIV protease inhibitors' such as ritonavir or indinavir (to treat HIV infection).
Maltese: Vivanza m'għandux jintuża ma' xi mediċini, bħall-ketoconazole u l-itraconazole (biex jikkuraw infezzjonijiet minn fungi) f'irġiel ta' iktar minn 75 sena, jew ma' mediċini msejħa ‘inibituri tal-proteażi tal-HIV bħar-ritonavir jew l-indinavir (biex jikkuraw infezzjoni tal-HIV).
English: What is Vivanza?
Maltese: X'inhu Vivanza?
English: The dose may be increased to a maximum of 20 mg or decreased to 5 mg depending on the effectiveness and side effects.
Maltese: Id-doża tista' tiżdied għal massimu ta' 20 mg jew titnaqqas għal 5 mg skont l-effikaċja u l-effetti sekondarji.
English: It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Maltese: Din taħdem billi timblokka l-enzima fosfodjesterażi li normalment tkisser sustanza magħrufa bħala monofosfat gwanożin ċikliku (cGMP).
English: Vivanza film-coated tablets have been compared with placebo (a dummy treatment) in four main studies including 2,431 men aged 20 to 83 years.
Maltese: Il-pilloli miksija b'rita Vivanza tqabblu mal-plaċebo (kura finta) f'erba' studji ewlenin bis-sehem ta' 2,431 raġel ta' bejn l-20 u t-83 sena.
English: The recommended dose of Vivanza is 10 mg, taken by mouth with or without food, about 25 to 60 minutes before sexual activity; patients should not take more than one dose a day.
Maltese: Id-doża rakkomandata ta' Vivanza hi ta' 10 mg, meħuda mill-ħalq, weħidha jew mal-ikel, madwar 25 sa 60 minuta qabel l-attività sesswali; il-pazjenti m'għandhomx jieħdu aktar minn doża waħda kuljum.
English: • patients with unstable angina or hereditary eye problems known as ‘retinal degenerative disorders'.
Maltese: • pazjenti li jsofru minn anġina instabbli jew problemi ereditarji fl-għajnejn magħrufa bħala ‘disturbi deġenerattivi tar-retina'.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Maltese: Waqt stimulazzjoni sesswali normali, fil-pene tiġi prodotta s-cGMP li tikkawża r-rilassament fil-muskolu fit-tessut tal-pene li qisu sponża (il-korpora kavernoża).
English: • patients who have hypotension (low blood pressure);
Maltese: • pazjenti li għandhom ipotensjoni (pressjoni baxxa tad-demm);
English: Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 years.
Maltese: Żewġ studji ewlenin oħra qabblu l-pilloli orodispersibbli malplaċebo f'701 irġiel ta' bejn il-21 u l-84 sena.
English: Vivanza must not be taken with nitrates (medicines used to treat angina).
Maltese: Vivanza m'għandux jittieħed flimkien ma' nitrati (mediċini użati fil-kura tal-anġina).
English: What is the risk associated with Vivanza?
Maltese: X'inhu r-riskju assoċjat ma' Vivanza?
English: In addition, Vivanza must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).
Maltese: Barra minn dan, Vivanza m'għandux jittieħed ma' mediċini magħrufa bħala stimulaturi gwanilat ċiklażi (guanylate cyclase), inkluż riociguat (użat biex jikkura ipertensjoni pulmonari [pressjoni għolja taddemm fil-pulmun]).
English: A risk management plan has been developed to ensure that Vivanza is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Vivanza jintuża bl-aktar mod sigur possibbli.
English: Patients with liver problems or severe kidney problems should start treatment on the 5 mg dose.
Maltese: Il-pazjenti bi problemi fil-fwied jew bi problemi severi fil-kliewi għandhom jibdew il-kura bid-doża ta' 5 mg.
English: How has Vivanza been studied?
Maltese: Kif ġie studjat Vivanza?
English: Vivanza is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Maltese: Vivanza jintuża fil-kura ta' rġiel adulti b'disfunzjoni erettili (xi drabi tissejjaħ impotenza), meta ma jkunx jista' jkollhom, jew ma jkunux jistgħu jżommu l-pene iebes (erezzjoni) b'mod suffiċjenti għal attività sesswali sodisfaċenti.
English: The CHMP decided that Vivanza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Vivanza huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: For the full list of all side effects reported with Vivanza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati b'Vivanza, ara l-fuljett ta' tagħrif.
English: Globalisation
Maltese: Globalizzazzjoni
English: YEAR 2015
Maltese: 7 Awissu 2015
English: EMA/773839/2014 Rev. 1 Management Board
Maltese: EMA/372771/2015
English: ISO
Maltese: Prijoritajiet
English: The final elements of the EU's pharmacovigilance legislation will be implemented during 2015 and 2016.
Maltese: L-elementi finali tal-leġiżlazzjoni tal-UE dwar il-farmakoviġilanza se jiġu implimentati matul l-2015 u l2016.
English: • Further increase transparency and implement stakeholder and communication strategies.
Maltese: • Tkompli tiżdied it-trasparenza u jiġu implimentati strateġiji ta' komunikazzjoni u mal-partijiet ikkonċernati.
English: ad hoc expert group on veterinary novel therapies
Maltese: Il-leġiżlazzjoni dwar mediċini veterinarji
English: • Ensure efficient crisis management and responsiveness to public health threats, including addressing antimicrobial resistance and the availability of anti-infective treatments.
Maltese: • Tiġi żgurata ġestjoni effiċjenti tal-kriżijiet u r-responsività għal theddid għas-saħħa pubblika, inkluż l-indirizzar ta' reżistenza antimikrobika u d-disponibbiltà ta' kura anti-infettiva.
English: Q4 2013 Q1 2015 • eAF ready for mandatory use for Centralised, National, MRP and DCP procedures PSUR Repository Q4 2013 Q2 2015 • Functional PSUR repository (basic functionality) eCTD 4 review tool
Maltese: Fl-2015, l-Aġenzija se tkun qed tikkapitalizza fuq il-programm reċenti tagħha biex iżżid l-effikaċja u l-effiċjenza tal-attivitajiet.
English: The process for evaluating medicines is constantly evolving.
Maltese: Il-proċess għall-valutazzjoni tal-mediċini qed jevolvi kontinwament.
English: • Business case • Functional Specifications eCollaboration programme eSubmission Gateway v.3
Maltese: • Titjib fil-kwalità, fl-integrazzjoni u fl-aċċessibbiltà tad-data miżmuma mill-Aġenzija.
English: Dec (pre-pay) Jan - Mar Apr-Jun Jul - Sep Oct - Dec
Maltese: It-trasparenza tal-proċess tat-teħid tad-deċiżjonijiet matul iċ-ċiklu tal-ħajja tal-mediċini tibqa' xprunatur ewlieni.
English: Key influences
Maltese: Influwenzi ewlenin
English: The network has access to thousands of experts from Member States across Europe, allowing it to source the best-possible expertise for the regulation of medicines in the European Union (EU).
Maltese: In-netwerk għandu aċċess għal eluf ta' esperti mill-Istati Membri fl-Ewropa kollha, li jippermettulu li jiġbor l-aqwa kompetenza possibbli għar-regolazzjoni ta' mediċini fl-Unjoni Ewropea (UE).
English: Transatlantic Taskforce on Antimicrobial Resistance
Maltese: Reżistenza antimikrobika u theddid ieħor għas-saħħa pubblika
English: Publish the report on the impact of the EU PROTECT project on medicines development, regulation and pharmacovigilance Launch literature monitoring service Publish Good practice guide on coding & reporting and on risk minimisation & prevention of medication errors Develop, test and validate a Standardised MedDRA Query (SMQ) on medication errors to facilitate ICSR data retrieval as a first step in investigating drug safety issues Prepare (2015) and publish (2016) a report on methods and approach for measuring pharmacovigilance impact Finalise remaining GVP modules
Maltese: LAġenzija se tkompli timplimenta wkoll il-proġett ta' Sorveljanza Ewropea tal-Konsum tal-Antimikrobiċi Veterinarji (ESVAC), li jiġbor informazzjoni dwar kif il-mediċini antimikrobiċi jintużaw fl-annimali fl-UE kollha, u b'hekk tippermetti fehim aħjar tal-fatturi ta' riskju li jwasslu għall-iżvilupp u t-tixrid ta' reżistenza antimikrobika.
English: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
Maltese: In-netwerk regolatorju Ewropew tal-mediċini
English: • Implement pharmacovigilance legislation and the clinical trials legislation.
Maltese: • Tiġi implimentata l-leġiżlazzjoni dwar il-farmakoviġilanza u l-leġiżlazzjoni dwar il-provi kliniċi.
English: The European medicines regulatory system is based on a network of around 50 human and veterinary medicines regulatory authorities ('national competent authorities', or NCAs) from the 31 European Economic Area countries and the European Medicines Agency.
Maltese: Is-sistema regolatorja tal-mediċini Ewropea hija bbażata fuq netwerk ta' madwar 50 awtorità regolatorja tal-mediċini tal-bniedem u veterinarji (‘awtoritajiet nazzjonali kompetenti', jew NCAs) mill31 pajjiż taż-Żona Ekonomika Ewropea u mill-Aġenzija Ewropea għall-Mediċini.
English: Robust internal processes and expansion of the overall capabilities of the Network will be required.
Maltese: Se jkunu meħtieġa proċessi interni robusti u l-espansjoni tal-kapaċitajiet ġenerali tan-Netwerk.
English: • Provide technical support to the European Commission during the co-decision process for the proposal on revision of the veterinary medicines legislation in the Council and the European
Maltese: • Jingħata appoġġ tekniku lill-Kummissjoni Ewropea matul il-proċess ta' kodeċiżjoni għall-proposta dwar ir-reviżjoni tal-leġiżlazzjoni dwar il-mediċini veterinarji fil-Kunsill u fil-Parlament Ewropew.
English: The implementation of the policy on access to clinical data will also be a significant aspect of the Agency's transparency initiatives.
Maltese: L-implimentazzjoni tal-politika dwar l-aċċess għal data klinika se tkun ukoll aspett sinifikanti talinizjattivi ta' trasparenza tal-Aġenzija.
English: Response to RFI within set timelines n/a
Maltese: It-teknoloġija tal-informatika u l-midja soċjali
English: Organization (WHO), thus highlighting AMR as a global health crisis of similar importance to pandemics of an infectious disease.
Maltese: Is-severità tal-kwistjoni hija rikonoxxuta wkoll mill-iżvilupp ta' pjan ta' azzjoni globali dwar l-AMR millOrganizzazzjoni Dinjija tas-Saħħa (WHO), li dan enfasizza l-AMR bħala kriżi globali tas-saħħa b'importanza simili għal pandemiji ta' marda infettiva.
English: Activity statement: Effectiveness & PhEpi studies Objective: See WP2015/16, heading 1.5 Budget: € 350,000 Financial year: 2015 Description of action: Ensuring best evidence is available to support the EMA committees assessments of the benefits and risks of authorised medicines (studies of risks and benefit risk) Type of contract: Framework contract; Specific contract per study Number of contracts: 5 framework contracts; 4-6 specific contracts per year Indicative timeframe for contract: Framework contracts to be in place Q2 2015; first specific contract approx. Q4 2015 Indicative timeframe for procurement: First reopening of competition: Q3 2015 Indicative budget for procurement: € 350,000 Legal basis: Regulation 726/2004 and Directive 2001/83, notably articles 31 and 107i - k Budget line: B3030
Maltese: Għalhekk, l-Aġenzija se tkompli tipprovdi appoġġ tekniku lill-Kummissjoni Ewropea (‘Kummissjoni', jew KE) fir-rigward tad-diskussjoni fil-Parlament Ewropew u fil-Kunsill dwar ilproposta tagħhom għal reviżjoni tal-leġiżlazzjoni veterinarja, inkluż dwar emendi għall-qafas għallawtorizzazzjoni ta' mediċini veterinarji innovattivi, is-simplifikazzjoni taż-żamma tal-prodotti veterinarji wara l-awtorizzazzjoni, il-farmakoviġilanza u aspetti oħra.
English: paediatric investigation plan
Maltese: Viċi Direttur Eżekuttiv
English: In the veterinary area attention is focussed in particular on ensuring the continued availability of antimicrobials for treatment of infectious disease in animals whilst recognising the need to preserve the efficacy of certain critically important antimicrobials for human use.
Maltese: Din hija aggravata mill-fatt li matul l-aħħar ftit snin, ftit antimikrobiċi ġodda ġew awtorizzati.
English: • Impact analysis of the eCTD 4 standard on the EMA
Maltese: Il-prijoritajiet u l-influwenzi ewlenin tal-EMA
English: Academia, SMEs and public private partnerships are an increasingly important source of innovation in medicines.
Maltese: Flimkien mal-SMEs, l-akkademja u s-sħubiji pubbliċi-privati qed isiru wkoll sors dejjem aktar importanti ta' innovazzjoni fil-mediċini.
English: This year, 2015, will be the 20th anniversary of the inauguration of the EMA, and the beginning of not only centralised approval of medicines, but of the whole European medicines network.
Maltese: Din is-sena, l-2015, se tkun l-20 anniversarju mill-inawgurazzjoni tal-EMA, u l-bidu mhux biss ta' approvazzjoni ċentralizzata tal-mediċini, iżda tan-netwerk Ewropew kollu tal-mediċini.
English: Activity statement: EU Network Training Centre: Virtual training from academia to support the scientific and regulatory training for the EU Network Objective: See WP2015/16, heading 3.3 Budget: ~€400,000 per year over 4 years (total: € 1.6 million); € 200,000 in 2015 Financial year: 2015 - 2018/19 Description of action: Enhance cooperation within European Medicines Regulatory Network Type of contract: Framework contracts - buy scientific and regulatory virtual training; Specific contracts Number of contracts: 3 Indicative timeframe for contract: Commencing in 2016 Indicative timeframe for procurement: Q2 2015 Indicative budget for procurement: € 1.6 million Legal basis: Article 27 of Regulation 726/2004 Budget line: B3003
Maltese: Għalhekk, l-EMA se tkompli l-kollaborazzjoni tagħha mal-UE u mal-imsieħba internazzjonali tagħha dwar għadd ta' inizjattivi mmirati biex jiġi limitat l-iżvilupp ta' AMR. Bħala parti minn din il-ħidma, l-Aġenzija se tkompli tikkontribwixxi għall-ħidma tat-Task Force Transatlantika dwar ir-Reżistenza Antimikrobika (TATFAR), li għandha l-għan li żżid il-livelli ta' komunikazzjoni, koordinazzjoni u kooperazzjoni bejn l-UE u l-Istati Uniti dwar antimikrobiċi tal-bniedem u veterinarji.
English: Activity statement: Provision of software development, integration services, solutions and IT Security and Network consultancy Objective: See WP2015/16, heading 4 Budget: Approx. €80.0 million over 4 years; of which € 40.0 million administrative and € 40.0 million operational Financial year: 2016 - 2020 Description of action: Provision of software development, integration services, solutions and IT Security and Network consultancy Type of contract: Framework contract and Specific contracts Number of contracts: 30 - 50 Indicative timeframe for contract: Commencing in 2016 Indicative timeframe for procurement: Q2/Q3 2015 Indicative budget for procurement: € 80,000,000 Legal basis: Article 57 of Regulation 726/2004 Budget line: B2114/2115/3105
Maltese: Għalhekk, l-aspetti kollha tal-ħidma tal-Aġenzija, mill-valutazzjoni inizjali sal-monitoraġġ ta' wara l-awtorizzazzjoni, qed isiru soġġetti għal skrutinju aktar intens mill-partijiet ikkonċernati u mill-komunità kollha kemm hi, b'impatt fuq il-fiduċja pubblika fil-ħidma tal-Aġenzija.
English: Consolidate the EU Network Data Board (EUNDB) Establish the IDMP Implementation Working Group with EMA and NCAs
Maltese: In-netwerk regolatorju Ewropew tal-mediċini (in-Netwerk) huwa l-pedament tal-ħidma u tas-suċċess tas-sistema Ewropea.
English: The growing trend for patients and healthcare professionals to use the internet, mobile communications and social media when searching for medicines-related information raises the importance of using these communication channels more widely, to ensure easy, consistent and timely access to authoritative, reliable and understandable information on medicines.
Maltese: It-tendenza dejjem tikber li l-pazjenti u l-professjonisti tal-kura tas-saħħa jużaw l-internet, ilkomunikazzjonijiet mobbli u l-midja soċjali meta jkunu qed ifittxu informazzjoni relatata mal-mediċini tqajjem l-importanza li dawn il-kanali ta' komunikazzjoni jintużaw b'mod aktar wiesa', biex jiġi żgurat aċċess faċli, konsistenti u f'waqtu għal informazzjoni awtorevoli, affidabbli u li tista' tinftiehem dwar ilmediċini.
English: Activity statement: Subscription to drug pipeline database Objective: See WP2015/16, heading 1.1 and 1.5 Budget: € 468,000 over 4 years Financial year: 2015 - 2018 Description of action: Access to one or several databases containing lifecycle data about medicinal products and medical devices for human use worldwide from pre-clinical to clinical studies phase IV to marketing to discontinued projects including adverse reaction, scientific and industry related information Type of contract: Service contract Number of contracts: 1 Indicative timeframe for contract: Commencing in 2015 Indicative timeframe for procurement: Q1 2015 Indicative budget for procurement: € 468,000 over 4 years Legal basis: Article 57 of Regulation 726/2004 Budget line: B3031
Maltese: Fis-snin li ġejjin, l-Aġenzija qed tistenna żieda sinifikanti fl-attivitajiet tagħha, kemm f'termini ta' volumi (eż. konsulenza xjentifika u farmakoviġilanza) kif ukoll f'termini ta' kumplessità tal-prodotti, ta' kwistjonijiet u proċeduri xjentifiċi, minħabba l-iżvilupp xjentifiku.
English: Subtotal SC Total SC Grand subtotal Grand total
Maltese: L-implimentazzjoni tal-programm għall-integrazzjoni tad-data hija l-attività ewlenija għall-Aġenzija f'dan il-qasam.
English: Article 33(4) of Directive 2001/82/EC, as amended
Maltese: Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendata
English: Veterinary Medicines Division
Maltese: Taqsima tal-Mediċini Veterinarji
English: For the pour-on product 24 concerned Member States are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Maltese: Stat Membru kkonċernat: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, irRepubblika Ċeka, id-Danimarka, l-Estonja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Islanda, lIrlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, irRumanija, is-Slovakkja, is-Slovenja u Spanja.
English: EMA/539462/2013
Maltese: 24 ta' Settembru 2013 EMA/620964/2013
English: The referral procedure started on 6 March 2013.
Maltese: Il-proċedura ta' riferiment inbdiet fis-6 ta' Marzu 2013.
English: The Committee appointed Dr C. Ibrahim as rapporteur and Ms H. Jukes as co-rapporteur.
Maltese: Jukes bħala ko-rapporteur.
English: These are ‘hybrid' applications according to Art. 13(3) Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose registered in the United Kingdom.
Maltese: Dawn huma applikazzjonijiet ‘ibridi' skont l-Art. 13(3) tad-Direttiva 2001/82/KE, kif emendata, li jirreferu għall-prodotti ta' referenza Pfizer Insettiċida li Jitferra' 1% w/v Soluzzjoni fuq il-Ġilda u Pfizer Insettiċida Għal Użu Lokalizzat 1% w/v Soluzzjoni fuq il-Ġilda b'aktar minn doża waħda rreġistrati firRenju Unit.
English: Opinion following an Article 33(4)0F referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle EMA/539462/2013
Maltese: Opinjoni wara riferiment tal-Artikolu 33(4)0F għal Deltanil 10 mg/ml Soluzzjoni li Titferra' għall-ifrat u n-nagħaġ u Deltanil 100 mg Soluzzjoni għall-Użu Lokalizzat għall ifrat EMA/620964/2013
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin as active ingredient and is intended for use in cattle and sheep as a topical application for the treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.
Maltese: Deltanil 10 mg/ml Soluzzjoni li Titferra' għall-ifrat u n-nagħaġ u Deltanil 100 mg Soluzzjoni għall-Użu Lokalizzat għall-ifrat fihom id-deltametrin bħala s-sustanza attiva u huma intenzjonati biex jintużaw filfrat u fin-ngħaġ bħala applikazzjoni topikali għall-kura u l-prevenzjoni ta' infestazzjonijiet minn briegħed u dubbien fuq frat; qurdien, qamel, keds u kolp stabbilit ta' blowfly fuq in-ngħaġ u qurdien fuq il-ħrief.
English: The applicant, Virbac, submitted an application for a decentralised procedure for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Maltese: L-applikant, Virbac, issottometta applikazzjoni għal proċedura deċentralizzata għal Deltanil 10 mg/ml Soluzzjoni li Titferra' għall-ifrat u n-nagħaġ u Deltanil 100 mg Soluzzjoni għall-Użu Lokalizzat għallifrat.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as concerned Member States.
Maltese: Fil-każ tal-prodott għall-użu lokalizzat, il-Belġju, Franza, il-Ġermanja u l-Pajjiżi l-Baxxi huma involuti bħala Stati Membri konċernati.
English: The decentralised procedure started on 19 December 2011.
Maltese: Il-proċedura deċentralizzata bidet fid-19 ta' Diċembru 2011.
English: On 26 February 2013, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fis-26 ta' Frar 2013, l-Istat Membru ta' referenza, ir-Renju Unit, innotifika lill-Aġenzija Ewropea talMediċini li s-CMD(v) naqas milli jasal għal ftehim rigward il-prodott u rrefera l-kwistjoni lis-CVMP skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: Therefore, the Committee adopted by majority a positive opinion on 17 July 2013 recommending the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Maltese: Għaldaqstant, il-Kumitat adotta b'maġġoranza opinjoni pożittiva fis-17 ta' Lulju 2013 li tirrakkomanda l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Deltanil 10 mg/ml Soluzzjoni li Titferra' għall-ifrat u n-nagħaġ u Deltanil 100 mg Soluzzjoni għall-Użu Lokalizzat għall-ifrat.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle is positive.
Maltese: Matul il-proċedura deċentralizzata, ġew identifikati riskji potenzjali serji mill-Ġermanja u mill-Pajjiżi l-Baxxi, rigward is-sigurtà ambjentali talprodott.
English: Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Maltese: Jum 60 tal-proċedura CMD(v) kien fl-14 ta' Frar 2013, u minħabba li l-Istati Membri konċernati naqsu milli jilħqu ftehim dwar il-prodott, il-proċedura ġiet riferuta lis-CVMP.