FrancophonIA/ELRC3.0 huggingface dataset:
English: In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times the maximum recommended human dose (MRHD), respectively, based on AUC (see section 5.3).
Maltese: Fi studji tar-riproduzzjoni talannimali, l-għoti mill-ħalq ta' fesoterodine lil ġrieden u fniek tqal matul organoġeneżi rriżulta f'fetotossiċità b'esponimenti maternali li kienu 6 darbiet u 3 darbiet id-doża umana rrakkomandata massima (MRHD, maximum recommended human dose), rispettivament, abbażi tal-AUC (ara sezzjoni 5.3). Ir-riskju li jista' jkun hemm fuq in-nies, mhux magħruf.
English: TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Maltese: TOVIAZ 8 mg pilloli li jerħu l-mediċina bil-mod fesoterodine fumarate
English: In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group.
Maltese: Fi studji kliniċi b'fesoterodine, każijiet ta' enzimi tal-fwied elevati sew kienu rrapportati mingħajr ebda differenza fil-frekwenza ta' każijiet mill-grupp li ħa l-plaċebo.
English: The interaction with CYP2D6 inhibitors was not tested clinically.
Maltese: Ma sar l-ebda studju kliniku fuq l-interazzjoni ma' impedituri ta' CYP2D6.
English: Urinary retention (including feeling of residual urine; micturition disorder);
Maltese: Żamma ta' l-awrina (inkluż sensazzjoni ta' awrina residwali:
English: Talk to your doctor before taking TOVIAZ, if any of the following apply to you: - if you have difficulties in completely emptying your bladder (for example due to prostate enlargement) - if you ever experience decreased bowel movements or suffer from severe constipation - if you are being treated for an eye disease called narrow angle glaucoma - if you have serious kidney or liver problems, your doctor may need to adjust your dose - if you have a disease called autonomic neuropathy which you notice from symptoms such as changes in your blood pressure or disorders in the bowel or sexual function - if you have a gastrointestinal disease that affects the passage and/or digestion of food - if you have heartburn or belching.
Maltese: Kellem lit-tabib tiegħek qabel ma tieħu TOVIAZ, jekk xi wieħed minn dawn li ġejjin japplika għalik: - jekk ikollok diffikultà tbattal kompletament il-bużżieqa ta' l-awrina (per eżempju minħabba nefħa tal-prostata) - jekk għandek tnaqqis fil-moviment ta' l-imsaren jew tbati minn stitikezza qawwija - jekk qed tkun ittrattat għall-marda ta' l-għajnejn li tissejjaħ glawkoma ta' l-angolu dejjaq - jekk għandek mard serju tal-kliewi jew fwied, it-tabib għandu mnejn jirranġa d-doża - jekk għandek marda msejħa newropatija autonomika li tinnutaha minn sintomi bħall-bdil fil pressjoni tad-demm tiegħek, u disturbi ta' l-imsaren jew il-funzjoni sesswali - jekk għandek mard gastrointestinali li jaffettwa l-passaġġ u/jew id-diġestjoni ta' l-ikel - jekk għandek ħruq ta' stonku jew tifwiq - jekk għandek infezzjoni fil-passaġġ tal-awrina, it-tabib tiegħek jista' jkollu bżonn itik xi antibijotiċi
English: Weak CYP3A4 inhibitors
Maltese: Impedituri qawwija ta' CYP3A4
English: Each tablet contains 4 mg fesoterodine fumarate
Maltese: Kull pilolla fiha 4 mg fesoterodine fumarate
English: After single or multiple-dose oral administration of fesoterodine in doses from 4 mg to 28 mg, plasma concentrations of the active metabolite are proportional to the dose.
Maltese: Wara t-teħid orali ta' darba jew iktar ta' fesoterodine b'dożi bejn 4mg u 28mg, il-konċentrazzjonijiet fil-plażma tal-metabolit attiv huma proporzjonali għad-doża li ngħatat.
English: - Severe central anticholinergic effects (e.g. hallucinations, severe excitation): treat with physostigmine - Convulsions or pronounced excitation: treat with benzodiazepines - Respiratory insufficiency: treat with artificial respiration - Tachycardia: treat with beta-blockers - Urinary retention: treat with catheterisation - Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room.
Maltese: John's Wort (prodott mediċinali bbażat fuq ilhxejjex), rifampicin (użat għat-trattament ta' infezzjonijiet batteriċi), carbamazepine, phenytoin u Phenobarbital (użati, fost affarijiet oħra għat-trattament ta' l-epilessija) - mediċini li fihom uħud minn dawn is-sustanzi attivi jistgħu jżidu il-livelli ta' fesoterodine fiddemm:
English: How to store TOVIAZ
Maltese: X'fih TOVIAZ
English: Moderate(3) or potent(4) CYP3A4 inhibitors None
Maltese: Mediċini potenti li jistimulaw is-CYP3A4
English: • trouble digesting food (dyspepsia)
Maltese: • problemi fid-diġestjoni tal-ikel (dispepsja)
English: Caution should be exercised in coadministration of fesoterodine with other antimuscarinics and medicinal products with anticholinergic properties (e.g. amantadine, tri-cyclic antidepressants, certain neuroleptics) as this may lead to more pronounced therapeutic- and side-effects (e.g. constipation, dry mouth, drowsiness, urinary retention).
Maltese: Kawtela għandha tiġi eżerċitata meta fesoterodine jingħata flimkien ma' mediċini antimuskariniċi oħra u prodotti mediċinali li għandhom karatteristiċi anti-kolinerġiċi (eż. amantadine, antidepressanti triċikliċi, xi newrolettiċi), għax dan jista' jwassal għal żieda fl-effett terapewtiku u fl-effetti sekondarji (eż. stitikezza ħalq xott, ngħas, żamma ta' l-awrina).
English: • nasal dryness
Maltese: • dardir (nawsja)
English: Organic causes must be excluded before any treatment with antimuscarinics is considered.
Maltese: Kawżi organiċi għandhom jiġu esklusi qabel ma jkun ikkunsidrat trattament b'mediċini antimuskariniċi.
English: Pfizer Polska Sp. z o.o.
Maltese: Pfizer Ελλάς A.E.
English: • extreme tiredness (fatigue)
Maltese: • dewmien fil-passagg ta' l-awrina (eżitazjoni urinarja)
English: In non-clinical safety pharmacology, general toxicity, genotoxicity and carcinogenicity studies no clinically relevant effects have been observed, except those related to the pharmacological effect of the active substance.
Maltese: Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku, effett tossiku fuq il-ġeni, riskju ta' kanċer, l-ebda effett kliniku rilevanti ma ġie osservat, ħlief dawk relatati ma' l-effett farmakoloġiku għas-sustanza attiva.
English: EUR thousand
Maltese: EUR eluf
English: CAP = centrally authorised product.
Maltese: CAP = centrally authorised product (PAK = prodott awtorizzat ċentralment).
English: There was a 5% decrease to 91 applications for initial evaluation of medicines.
Maltese: Kien hemm tnaqqis ta' 5% għal 91 applikazzjoni għal evalwazzjoni inizjali tal-mediċini.
English: Applications for maximum residue limits (MRLs)
Maltese: Applikazzjonijiet għal limiti massimi ta' residwi (MRLs)
English: 21 October 2011
Maltese: 21 ta' Ottubru 2011
English: Orphan medicines designation
Maltese: Nominazzjoni ta' prodotti mediċinali orfni
English: Pharmacovigilance and maintenance activities
Maltese: Attivitajiet ta' farmakoviġilanza u manteniment
English: • EMA launches public consultation on ethical and good-clinical-practice (GCP) aspects of clinical trials conducted in third countries.
Maltese: • L-EMA tniedi konsultazzjoni pubblika dwar aspetti ta' prassi klinika tajba (GCP) u etikali ta' testijiet kliniċi kondotti f'pajjiżi terzi.
English: • EMA and Swissmedic agree sharing of information on H1N1 pandemic medicines.
Maltese: • EMA u Swissmedic jaqblu li jikkondividu l-informazzjoni dwar il-mediċini pandemiċi tal-H1N1
English: These vaccines were authorised under exceptional circumstances to protect cattle and sheep against clinical signs, and to reduce or prevent transmission of serotypes 1, 2, 4 and 8 of the highly variable bluetongue virus.
Maltese: Dawn il-vaċċini kienu awtorizzati taħt ċirkostanzi eċċezzjonali sabiex jipproteġu frat u nagħaġ minn sinjali kliniċi, u biex inaqqsu jew jevitaw ittrasmissjoni tas-serotipi 1, 2, 4 u 8 tal-virus bluetongue ferm varjabbli.
English: Inspections
Maltese: Spezzjonijiet
English: Of the applications received, 46 related to new medicines, 12 of which were designated orphan medicines.
Maltese: Mill-applikazzjonijiet riċevuti, 46 kienu relatati ma' mediċini ġodda, 12 minnhom kienu mediċini klassifikati bħala orfni.
English: Number of quality defects reported
Maltese: Numru ta' difetti fil-kwalità rrapportati
English: Figure 8.
Maltese: Figura 8.
English: • A new H5N1 mock-up pandemic-influenza vaccine intended for the prevention of influenza during an officially declared pandemic situation (a mock-up pandemic vaccine is not intended for stockpiling, but can be used to speed up the availability of a final vaccine in the event of a pandemic, once the pandemic strain has been identified).
Maltese: • Vaċċin finta ġdid tal-influwenza pandemika kontra l-H5N1 maħsub għall-prevenzjoni tal-influwenza f'sitwazzjoni ddikjarata uffiċjalment bħala pandemika (vaċċin pandemiku finta mhux maħsub għallħażna, iżda jista' jintuża sabiex iħaffef d-disponibbiltà tat-tilqima finali f'każ ta' pandemija, ladarba tkun ġiet identifikata razza pandemika).
English: • EMA and US FDA agree to accept a single orphan-drug-designation annual report.
Maltese: • EMA u US FDA jaqblu li jaċċettaw rapport annwali ta' denominazzjoni ta' prodott mediċinali orfni waħdieni
English: These relate to 73 applications by active substance, representing an increase of 16% compared to 2009.
Maltese: Dawn jirrigwardaw 73 applikazzjoni minn sustanza attiva, li jirrappreżentaw żieda ta' 16% meta mqabbla mal2009.
English: Eight requests were for minor use/minor species (MUMS)/limited markets.
Maltese: Tmien talbiet kienu għal użu minuri / speċi minuri (MUMS) / swieq limitati.
English: Figure 16.
Maltese: Figura 16.
English: • EMA launches European paediatric research network (Enpr-EMA).
Maltese: • L-EMA tniedi n-netwerk Ewropew għar-riċerka pedjatrika (Enpr-EMA).
English: • EMA and US FDA extend their confidentiality arrangement indefinitely.
Maltese: • L-EMA u US FDA jestendu l-ftehim ta' kunfidenzjalità tagħhom b'mod indefinit.
English: Paediatric-investigation-plan (PIP) applications
Maltese: Applikazzjonijiet għal Pjan ta' investigazzjoni pedjatrika (PIP)
English: Referral procedures
Maltese: Proċeduri ta' riferiment
English: • A designated orphan medicine intended for the treatment of inborn errors in primary bile acid synthesis due to enzyme deficiencies.
Maltese: • Prodott mediċinali denominat orfni maħsub għat-trattament ta' difetti konġenitali fis-sinteżi talaċidu biljari primarju minħabba defiċjenzi fl-enzimi.
English: • Prepandemic-influenza vaccines intended for immunisation against the H5N1 subtype of the influenza-A virus.
Maltese: • Vaċċini kontra l-influwenza pandemika huma maħsuba għal tilqim kontra s-subtip H5NI tal-virus tal-influwenza-A.
English: Maximum Residue Limits
Maltese: Limiti Massimi ta' Residwi
English: Figure 9.
Maltese: Figura 9.
English: ADR = adverse drug reaction.
Maltese: ADR = reazzjoni avversa għall-mediċina.
English: Herbal medicines
Maltese: Mediċini erbali
English: Initial evaluation
Maltese: Evalwazzjoni inizjali
English: Figure 12.
Maltese: Figura 12.
English: Figure 17.
Maltese: Figura 17.
English: Figure 11.
Maltese: Figura 11.
English: Figure 13.
Maltese: Figura 13.
English: Figure 10.
Maltese: Figura 10.
English: • EMA receives the 1,000th application for a paediatric investigation plan (PIP) or waiver.
Maltese: • L-EMA tirċievi l-1,000 applikazzjoni għal pjan ta' investigazzjoni pedjatrika (PIP) jew rinunzja.
English: Figure 14.
Maltese: Figura 14.
English: • EMA publishes a new access-to-documents policy.
Maltese: • L-EMA tippubblika aċċess ġdid għal politika dwar id-dokumenti
English: Figure 7.
Maltese: Figura 7.
English: Figure 15.
Maltese: Figura 15.
English: • Two designated orphan medicines intended for the treatment of pulmonary conditions; one for suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis, and another for idiopathic pulmonary fibrosis.
Maltese: • Żewġ prodotti mediċinali denominati orfni maħsuba għall-kura ta' kundizzjonijiet pulmunari; waħda għat-terapija soppressiva ta' infezzjoni kronika fil-pulmun minħabba Pseudomonas aeruginosa filfibrożi ċistika, u oħra għall-fibrożi pulmonari idjopatika.
English: Scientific advice is provided on any aspect of research and development relating to quality, safety or efficacy of medicines for veterinary use, and to the establishment of maximum residue limits.
Maltese: Huwa pprovdut parir xjentifiku dwar kull aspett ta' riċerka u żvilupp rigward il-kwalità, sigurtà jew effikaċja tal-mediċini għall-użu veterinarju, u għall-istabbiliment ta' limiti massimi ta' residwu.
English: • A diagnostic agent intended as a pharmacological stress agent for radionuclide myocardial perfusion imaging.
Maltese: • Aġent dijanjostiku maħsub bħala aġent ta' stress farmaloġiku għal immaġni ta' perfużjoni mijokardijaka radionuclide
English: • Four vaccines against bluetongue disease.
Maltese: • Erba' vaċċini kontra l-marda tal-bluetongue.
English: • EMA and Massachusetts Institute of Technology launch a joint project on regulatory science.
Maltese: • L-EMA u l-Istitut tat-Teknoloġija tal-Massachusetts iniedu proġett konġunt dwar ix-xjenza regolatorja.
English: Figure 6.
Maltese: Figura 6.
English: Type-IA variations Type-IB variations Type-II variations Line extensions
Maltese: Varjazzjonijiet Tip-IA Varjazzjonijiet Tip-IB Varjazzjonijiet Tip-II
English: Orphan medicines contribution
Maltese: Denominazzjoni ta' prodotti mediċinali orfni
English: Second quarter: April-June 2010
Maltese: April-Ġunju 2010
English: Fourth quarter: October-December 2010
Maltese: Ottubru- Diċembru 2010
English: The year also saw a number of high-profile opinions being established, such as the recommendation to suspend the marketing authorisation for Avandia and other medicines containing rosiglitazone, the suspension of the anti-obesity medicine sibutramine, and investigations into the childhood vaccines Rotarix and Rotateq, following the detection of unexpected viral material.
Maltese: Is-sena rat ukoll numru ta' opinjonijiet ta' profil għoli jiġu stabbiliti, bħar-rakkomandazzjoni li tiġi sospiża l-awtorizzazzjoni għattqegħid fis-suq għal Avandia u mediċini oħra li fihom rosiglitazone, is-sospensjoni tal-mediċina kontra l-obeżità sibutramine, u l-investigazzjonijiet fit-tilqim għat-tfal Rotarix and Rotateq, wara li ġie skopert xi materjal virali mhux mistenni.
English: Referrals started Referrals finalised
Maltese: Talbiet għal pariri xjentifiċi riċevuti u ffinalizzati
English: Third quarter: July-September 2010
Maltese: Lulju-Settembru 2010
English: • A designated orphan medicine produced using recombinant DNA technology, intended for the treatment of angioedema attacks.
Maltese: • Prodott mediċinali denominat orfni prodott b'teknoloġija rikombinanti tad-DNA, maħsub għattrattament ta' attakki ta' anġjoedima.
English: • A medicinal product intended for maintenance treatment of severe chronic obstructive pulmonary disease associated with chronic bronchitis in adult patients as add-on to bronchodilator treatment, presenting an oral treatment with a new mode of action.
Maltese: • Prodott mediċinali maħsub għal kura ta' manteniment ta' mard pulmonari ostruttiv kroniku sever assoċjat ma' bronkite kronika f'pazjenti adulti bħala żieda mal-kura bil-bronkodilatur, li jippreżenta kura orali b'mod ta' azzjoni ġdid.
English: • EMA Management Board launches new 'Road map to 2015'.
Maltese: • Il-Bord ta' Tmexxija tal-EMA jniedi il-‘Pjan direzzjonali għall-2015'.
English: Reports on serious suspected adverse drug reactions (ADRs) in animals and humans
Maltese: Rapporti dwar reazzjonijiet avversi suspetti tal-mediċina (ADRs) fl-annimali u l-bnedmin
English: First quarter: January-March 2010
Maltese: Jannar-Marzu 2010
English: And in November, we took a major step forward in transparency, publishing a policy on access to documents that gives wider public access than ever before to the documents we hold concerning both human and veterinary medicines.
Maltese: U f'Novembru, għamilna pass kbir ilquddiem fit-trasparenza, billi ppubblikajna politika dwar l-aċċess għad-dokumenti li tagħti aċċess pubbliku usa' minn qatt qabel għad-dokumenti li għandna li jikkonċernaw kemm mediċini għallbniedem kif ukoll mediċini veterinarji.
English: The year 2010 saw many changes at the European Medicines Agency, the most poignant of which was the departure of the Agency's Executive Director, Thomas Lönngren.
Maltese: Is-sena 2010 rat bosta bidliet fl-Aġenzija Ewropea għall-Mediċini, bl-aktar waħda emozzjonali tkun ittluq tad-Direttur Eżekuttiv tal-Aġenzija, Thomas Lönngren.
English: • EMA starts review of Pandemrix over narcolepsy concerns.
Maltese: • L-EMA tibda reviżjoni ta‘ Pandemrix dwar tħassib ta' narkolessija.
English: Pharmacovigilance and maintenance activities Pharmacovigilance covers the activities relating to the detection, assessment, understanding and prevention of adverse drug reactions (ADRs) or other drug-related problems.
Maltese: Il-farmakoviġilanza tkopri l-attivitajiet relatati mas-sejbien, valutazzjoni, fehim u l-prevenzjoni ta' reazzjonijiet avversi tal-mediċina (ADRs) jew problemi relatati mal-mediċina.
English: • EMA recommends suspension of Avandia, Avandamet and Avaglim over cardiovascular concerns.
Maltese: • L-EMA tirrakkomanda s-sospensjoni ta' Avandia, Avandamet u Avaglim minħabba tħassib kardjovaskolari.
English: • EMA holds international workshop on clinical trials in the context of global medicines development.
Maltese: • L-EMA torganizza workshop internazzjonali dwar provi kliniċi fil-kuntest tal-iżvilupp globali tal mediċini.
English: This area covers the Agency's activities relating to the assessment and agreement of, and verification of compliance with, paediatric investigation plans (PIPs) and waivers by the Paediatric Committee (PDCO).
Maltese: Dan il-qasam ikopri l-attivitajiet tal-Aġenzija dwar l-evalwazzjoni u l-ftehim dwar, u l-verifika talkonformità ma', pjanijiet ta' investigazzjonijiet pedjatriċi (PIPs) u rinunzji tal-Kumitat Pedjatriku (PDCO).
English: Scientific-advice requests received and finalised
Maltese: Proċeduri ta' riferiment mibdija u ffinalizzati
English: • A designated orphan medicine intended for the treatment of patients with chronic lymphocytic leukaemia.
Maltese: • Prodott mediċinali denominat orfni maħsub għat-trattament ta' pazjenti b'lewkimja limfoċitika kronika.
English: A report on the evaluation of the Agency, carried out by Ernst & Young, was published at the beginning of the year.
Maltese: Rapport dwar l-evalwazzjoni ta 'l-Aġenzija, imwettaq minn Ernst & Young, ġie ppubblikat fil-bidu tas-sena.
English: On the human side, the number of post-authorisation activities, orphan-medicine designations, scientificadvice procedures and referrals continued to grow.
Maltese: Mil-lat uman, in-numru ta' attivatijiet ta' wara l-awtorizzazzjoni, denominazzjonijiet ta' mediċini orfni, proċeduri ta' pariri xjentifiċi u referenzi kompla jikber.
English: Thomas left the Agency in December after ten successful years at its helm, overseeing the phenomenal growth of the Agency, not only in terms of sheer size, but also in the range of its activities.
Maltese: Thomas ħalla l-Aġenzija f'Diċembru wara għaxar snin ta' suċċess fit-tmexxija tagħha, jissorvelja t-tkabbir fenomenali tal-Aġenzija, mhux biss f'termini purament ta' daqs, iżda wkoll fil-firxa tal-attivitajiet tagħha.
English: The Agency's Committee on Herbal Medicinal Products (HMPC), with a view to promote an increasingly harmonised process for licensing and information on herbal substances across the EU, establishes Community herbal monographs for traditional and well-established herbal medicines as well as a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicines.
Maltese: Il-Kumitat tal-Aġenzija dwar Prodotti Mediċinali Erbali (HMPC), bil-għan li jippromwovi proċess dejjem aktar armonizzat għall-ħruġ ta' liċenzji u informazzjoni fuq sustanzi erbali madwar l-UE, jistabbilixxi monografi komunitarji dwar ħxejjex għal mediċini erbali tradizzjonali u stabbiliti sew, kif ukoll abbozz ta' lista ta' sustanzi erbali , preparazzjonijiet u kombinazzjonijiet tagħhom għall-użu fi prodotti mediċinali erbali tradizzjonali.
English: It is extracted from the milk of rabbits that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Maltese: Huwa estratt mill-ħalib tal-fniek li kellhom ġene (DNA) inserit, li jagħmilhom kapaċi jipproduċu l-proteina umana fil-ħalib tagħhom.
English: The Agency coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), and with pharmacovigilance obligations and certain aspects of the supervision of authorised medicinal products in use in the European Union.
Maltese: L-Aġenzija tikkoordina l-verifika tal-konformità mal-prinċipji tal-prattiki tajba ta' manifattura (PTM), prattiki tajba tal-laboratorju (PTL), u mal-obbligi tal-farmakoviġilanza u ċerti aspetti tas-sorveljanza ta' prodotti mediċinali awtorizzati użati fl-Unjoni Ewropea.
English: • EMA and other stakeholders launch pilot for multi-stakeholder consultations in early-stage drug development.
Maltese: • L-EMA u partijiet interessati oħra jniedu prova għal konsultazzjonijiet għal bosta partijiet interessati fi stadju bikri ta' żvilupp tal-mediċina
English: • Two medicinal products intended for the treatment of psychiatric conditions; one for moderate to severe manic episodes associated with bipolar I disorder, and another for the treatment of schizophrenia.
Maltese: • Żewġ prodotti mediċinali maħsubin għall-kura ta' kundizzjonijiet psikjatriċi; wieħed għal episodji manijaċi minn moderati għal severi assoċjati ma' disturb bipolari I, u ieħor għall-kura taliskiżofrenija.
English: MRL extrapolations
Maltese: Mediċini għat-tfal
English: • Two H1N1 pandemic vaccines intended for the prophylaxis of influenza in an officially declared pandemic situation.
Maltese: • Żewġ vaċċini għall-pandemija tal-H1N1 maħsuba għall-profilassi tal-influwenza f'sitwazzjoni ddikjarata uffiċjalment bħala pandemika.
English: The initial evaluation phase covers activities relating to the processing of marketing authorisation applications for veterinary medicines, ranging from pre-submission meetings with future applicants, through evaluation by the Committee for Medicinal Products for Veterinary Use (CVMP), to the granting by the European Commission of the marketing authorisation.
Maltese: Il-fażi ta' evalwazzjoni inizjali tkopri attivitajiet relatati mal-ipproċessar ta' applikazzjonijiet għallawtorizzazzjoni għat-tqegħid fis-suq ta' mediċini veterinarji, li jvarjaw mil-laqgħat ta' qabel issottomissjoni mal-applikanti futuri, għall-evalwazzjoni mill-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP), għall-għoti mill-Kummissjoni Ewropea tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Animal-health benefits of medicines for veterinary use recommended for approval in 2010
Maltese: Benefiċċji ta' mediċini għal saħħet l-annimali għal użu veterinarju rakkomandati għall-approvazzjoni fl-2010
English: • EMA and EUnetHTA Joint Action start collaboration on improving European public assessment reports (EPARs) for better contribution to relative effectiveness assessments.
Maltese: • EMA u l-Azzjoni Konġunta ta' EUnetHTA jibdew kollaborazzjoni dwar it-titjib tar-rapporti pubbliċi Ewropej ta' Valutazzjoni (EPARs) għal kontribut aħjar għall-valutazzjonijiet tal-effikaċja relattiva.
English: • A vaccine to reduce the shedding of Coxiella burnetii by infected cattle and goats.
Maltese: • Tilqima li tnaqqas t-twaqqigħ ta' Coxiella burnetii minn bhejjem infettati u mogħoż.
English: It aims at ensuring that post-authorisation monitoring and effective risk-management are continuously applied to veterinary medicines throughout the EU.
Maltese: L-għan tagħha huwa li tiżgura li l-monitoraġġ ta' wara l-awtorizzazjoni u l-ġestjoni tar-riskju effettiva huma kontinwament applikati għall-mediċini veterinarji fl-UE kollha.