FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of new indications related to medicinal products approved for the treatment of various forms of cancer.
Maltese: Il-maġġoranza ta' l-indikazzjonijiet il-ġodda kienu għal prodotti mediċinali approvati għall-kura ta' diversi forom ta' kanċer.
English: Italy 10% Ireland
Maltese: L-Irlanda, 11
English: Of these, 21 resulted in a product recall (19 human medicines and 2 veterinary medicines); the remainder of the defects reported were classified as minor.
Maltese: Minn dawn, 21 irriżultaw f'sejħa lura tal-prodott (19-il mediċina għall-bniedem u 2 mediċini veterinarji); ilbqija tad-difetti rrapportati ġew klassifikati bħala minuri.
English: In order to further progress the direct electronic reporting of adverse reactions into the EudraVigilance Veterinary database, a simplified electronic reporting tool was made available, designed particularly for use by smaller companies in the veterinary industry.
Maltese: Sabiex ikun hemm aktar progress fir-rapportaġġ elettroniku dirett tar-reazzjonijiet mhux mixtieqin fiddatabase ta' l-‘EudraVigilance Veterinary', għodda ta' rapportaġġ elettroniku simplifikat saret disponibbli għall-użu ta' kumpaniji iżgħar fl-industrija veterinarja.
English: Referral procedures concluded in 2006
Maltese: Proċeduri ta' riferimenti konklużi fl-2006
English: On 15 December 2005, the EMEA launched an ‘SME Office' to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs.
Maltese: Fil-15 ta' Diċembru 2005, l-EMEA nediet ‘Uffiċċju SME' biex jipprovdi assistenza finanzjarja u amministrattiva lil intrapriżi ta' daqs żgħir ħafna, żgħar u ta' daqs medju (SMEs), bil-għan li jippromovi l-innovazzjoni u l-iżvilupp tal-prodotti mediċinali ġodda għall-bniedem u veterinarji millSMEs.
English: The full EMEA annual report for 2006 was adopted by the Management Board on 8 March 2007, and is available on the EMEA website:
Maltese: Ir-rapport annwali sħiħ ta' l-EMEA għall-2006 ġie adottat mill-Bord ta' Tmexxija fit-8 ta' Marzu 2007, u jinstab fuq il-website ta' l-EMEA :
English: Actual and estimated numbers of EU and non-EU adversedrug-reaction reports transmitted to the EMEA, 2004-2006
Maltese: Numri proprji u dawk stmati ta' rapporti ta' reazzjonijiet mhux mixtieqa ghal medicini (ADRs) mill-UE u barra l-UE trasmessi lill-EMEA, 2004-2006
English: Opinions for extrapolations
Maltese: Opinjonijiet g?al estrapolazzjonijiet
English: Sixty percent of orphan products designated in 2006 were for conditions that affect children, including 14% intended exclusively for paediatric use.
Maltese: Sittin fil-mija tal-prodotti orfni klassifikati fl-2006 kienu għal kondizzjonijiet li jolqtu lit-tfal, inkluż 14% maħsuba esklussivament għal użu pedjatriku.
English: A centrally authorised perflutren-containing microspheres medicinal product (Optison), further to the suspension of a manufacturing authorisation due to concerns over compliance with good manufacturing practice (GMP).
Maltese: Prodott mediċinali awtorizzat ċentralment li jikkonsisti f'mikro-sferi li fihom il-perflutren (Optison), wara s-sospensjoni ta' awtorizzazzjoni ta' manifattura minħabba tħassib dwar ilkonformità ma' prattika tajba ta' manifattura (GMP).
English: There was 1 negative opinion (which was confirmed following a re-examination) for an antimicrobial for treatment of specific skin and softtissue infections and specific acute infections of the upper respiratory tract and the urinary tract in cats and dogs.
Maltese: Kien hemm opinjoni waħda negattiva (li kienet ikkonfermata wara eżami mill-ġdid) għal antimikrobiku għall-kura ta' infezzjonijiet speċifiċi tal-ġilda u tat-tessut artab u infezzjonijiet akuti speċifiċi tal-qasam respiratorju superjuri u l-qasam urinarju fil-qtates u l-klieb.
English: Alleviation of contra-indications and concomitant strengthening of warnings for beta-interferoncontaining medicinal products used in the treatment of multiple sclerosis.
Maltese: Titjib ta' kontra-indikazzjonijiet u tisħiħ konkomitanti ta' twissijiet għal prodotti mediċinali li fihom il-beta interferon użati fil-kura ta' sklerożi multipla.
English: This high number of notifications was attributable to: new parallel distributors starting this activity; parallel distributors complying with the mandatory notification procedure; recently authorised medicinal products entering the parallel-distribution chain; and enlargement by existing parallel distributors of their range of products.
Maltese: Dan in-numru għoli ta' notifiki huwa attribwit għal: distributuri paralleli ġodda li jibdew din lattività ; distributuri paralleli konformi mal-proċedura ta' notifika mandatorja ; prodotti mediċinali awtorizzati riċentement, li jidħlu fil-katina ta' distribuzzjoni parallela ; u t-tkabbir minn distributuri paralleli eżistenti fil-firxa ta' prodotti tagħhom.
English: Enhancements to permit semi-automatic batch upload are planned for 2007.
Maltese: Tisħiħ biex jippermetti batch upload semi-awtomatiku huwa ppjanat għall-2007.
English: 23 SMEs requested scientific advice and a total of €1.4 million in SME fee reductions was processed for scientific advice.
Maltese: 23 SME talbu parir xjentifiku u total ta' €1.4 miljun fi tnaqqis ta' miżati għal SME ġew proċessati għal pariri xjentifiċi.
English: EudraVigilance Veterinary became the main reporting tool for suspected adverse reactions used by national competent authorities in 2006.
Maltese: ‘EudraVigilance Veterinary' saret l-għodda prinċipali ta' rapportaġġ għal reazzjonijiet suspettati mhux mixtieqin użata mill-awtoritajiet nazzjonali kompetenti fl-2006.
English: The main change to the policy concerned a re-focusing of incentives on support for protocol assistance and other pre-authorisation assistance.
Maltese: Il-bidla prinċipali fil-politika kienet fokus mill-ġdid ta' l-inċentivi fuq appoġġ għal assistenza għal-protokoll u assistenza oħra ta' qabel l-awtorizzazzjoni.
English: In order to review the experience gained with risk-management plans to date, and to introduce further improvements, a Review and Learning Project was set up, involving the EMEA, CHMP, PhVWP and CMD(h).
Maltese: Sabiex tiġi riveduta l-esperjenza miksuba bil-pjanijiet tal-ġestjoni tar-riskju sal-ġurnata ta' llum, u biex jiġu introdotti aktar titjib, ġie stabbilit Proġett ta' Reviżjoni u Tagħlim, li jinvolvi l-EMEA, is-CHMP, il-PhVWP u s-CMD(h).
English: The decentralised procedure and the mutual recognition procedure apply to the majority of conventional medicinal products.
Maltese: Il-proċedura deċentralizzata u l-proċedura ta' rikonoxximent reċiproku japplikaw għallmaġġoranza tal-prodotti mediċinali konvenzjonali.
English: One product for treatment of benign prostatic hypertrophy in dogs.
Maltese: Prodott wieħed għall-kura ta' ipertrofija beninna tal-prostata fil-klieb.
English: Further progress was made in other areas too, notably our transparency, information and communication initiatives, preparations for the accession to the EU of Bulgaria and Romania, arrangements for the participation of Croatia and Turkey in EMEA activities, and international cooperation with our scientific and regulatory partners at the European and global levels.
Maltese: Sar progress ulterjuri f'oqsma oħrajn ukoll, b'mod partikolari l-inizjattivi tagħna għat-trasparenza, linformazzjoni u l-komunikazzjoni, preparazzjonijiet għall-adeżjoni ma' l-UE tal-Bulgarija u lRumanija, l-arranġamenti għall-parteċipazzjoni tal-Kroazja u t-Turkija fl-attivitajiet ta' l-EMEA, u lkooperazzjoni internazzjonali ma' l-imsieħba xjentifiċi u regolatorji tagħna fil-livelli Ewropej u globali.
English: 3.5 Safety of medicines for veterinary use
Maltese: 3.5 Sigurtà tal-mediċini għal użu veterinarju
English: Periodic safety-update reports,
Maltese: Opinjonijiet u notifiki ta' wara l-awtorizzazzjoni,
English: Following a request for consideration from a Member State, the CVMP recommended that new precautionary measures concerning user safety be added to the product literature of 21 veterinary medicinal products containing alpha2-adrenoreceptor agonists.
Maltese: Wara talba għal konsiderazzjoni minn Stat Membru, is-CVMP irrakkomandat li miżuri ġodda ta' prekawzjoni li jikkonċernaw is-sigurtà ta' l-utent għandhom jiġu miżjuda mal-letteratura tal-prodott ta' 21 prodott mediċinali veterinarji li jinkludu l-alpha2-adrenoreceptor agonists.
English: EMEA revenue in 2006
Maltese: PRIJORITAJIET FL-2006
English: As a complementary action, the Agency's Committee for Medicinal Products for Human Use established a think-tank on innovation, which is expected to report in 2007 on its meetings with pharmaceutical companies and academic groups.
Maltese: Bħala azzjoni komplementarja, ilKumitat għal Prodotti Mediċinali għall-Użu tal-Bniedem ta' l-Aġenzija waqqaf think-tank dwar linnovazzjoni, li huwa mistenni jirrapporta fl-2007 dwar il-laqgħat tiegħu mal-kumpaniji farmaċewtiċi u l-gruppi akkademiċi.
English: Positive opinion for first pandemic-influenza ‘mock-up' vaccine
Maltese: Opinjoni pożittiva għall-ewwel tilqima bi prova ta' influwenza pandemika
English: Mean duration of scientific-advice procedures (days), 2004-2006
Maltese: Tul ta' zmien medju ta' proceduri ta' pariri xjentifici (jiem), 2004-2006
English: Outcome of initial-evaluation applications (EU market), 2004-2006
Maltese: Ezitu ta' l-applikazzjonijiet ta' valutazzjoni inizjali (suq ta' l-UE), 2004-2006
English: 1.2 Improving access to medicines and stimulating R&D Implementing the new framework for scientific advice
Maltese: 1.2 Titjib ta' l-aċċess għal mediċini u l-istimulazzjoni ta' l-R&D L-implimentazzjoni ta' qafas ġdid għal pariri xjentifiċi
English: Czech Republic
Maltese: Ir-Repubblika Ceka, 18
English: Work is required to implement extended search, technical structuring of the content, incorporation of data from national competent authorities, and a multilingual approach.
Maltese: Hija meħtieġa ħidma biex tiġi implimentata t-tfittxija estiża, l-istrutturar tekniku tal-kontenut, l-inkorporazzjoni ta' data minn awtoritajiet kompetenti nazzjonali, u approċċ multilingwali.
English: Hungary
Maltese: Ohrajn
English: The EMEA continued to support all Member States on good-manufacturing-practice (GMP), goodclinical-practice (GCP), good-laboratory-practice (GLP) and pharmacovigilance inspection procedures.
Maltese: L-EMEA kompliet tappoġġja lill-Istati Membri kollha fl-oqsma tal-prattika tajba ta' manifattura (GMP), prattika klinika tajba (GCP), prattika tajba tal-laboratorju (GLP) u proċeduri ta' spezzjoni talfarmakoviġilanza.
English: In 2006, the EMEA received and validated 3 new applications for maximum residue limits (MRLs)the same number as in 2005, and 2 fewer than were forecast for the year.
Maltese: Fl-2006, l-EMEA rċeviet u vvalidat 3 applikazzjonijiet ġodda għal limiti massimi ta' residwi (MRLs) - l-istess numru bħal fl-2005, u 2 inqas milli kien imbassar għal dik is-sena.
English: The Agency organised a number of conferences, workshops and training sessions for assessors and inspectors, designed to share competencies and strengthen cooperation among the network of European experts.
Maltese: L-Aġenzija organizzat numru ta' konferenzi, workshops u sessjonijiet ta' taħriġ għall-valutaturi u lispetturi, immirati għall-iskambju ta' kompetenzi u t-tisħiħ tal-koperazzjoni fost in-network ta' esperti
English: Notifications of a change received Notices of a change issued
Maltese: Notifiki inizjali pagabbli ricevuti
English: The SME Office provided regulatory assistance to 14 companies.
Maltese: L-Uffiċċju SME ipprovda assistenza regolatorja għal 14-il kumpanija.
English: A mock-up vaccine is not intended for use outside a declared pandemic-influenza situation, 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: Tilqima bi prova m'hijiex intenzjonata għall-użu barra sitwazzjoni ta' influwenza pandemika ddikjarata, iżda tista' tintuża biex titħaffef id-disponibbiltà tat-tilqima finali filkaż ta' pandemija, ladarba tiġi identifikata l-istrain pandemika.
English: Procedures for ad hoc or emergency testing of centrally authorised products and for handling out-of-specification results were finalised and adopted.
Maltese: Ilproċeduri għall-ittestjar ad hoc jew ta' emerġenza ta' prodotti awtorizzati ċentralment u għallimmaniġjar ta' riżultati barra l-ispeċifikazzjoni ġew finalizzati u adottati.
English: The 5 pharmaceutical applications, 3 of which were generic applications, concerned medicinal products for dogs, while the 3 immunological applications concerned medicines for chickens principally.
Maltese: Il-5 applikazzjonijiet farmaċewtiċi, li 3 minnhon kienu applikazzjonijiet ġeneriċi, ikkonċernaw prodotti mediċinali għall-klieb, filwaqt li t-3 applikazzjonijiet immunoloġiċi kkonċernaw mediċini prinċipalment għat-tiġieġ.
English: Total staff-related expenditure
Maltese: Infiq totali relatat malpersunal
English: The investigations revealed some regulatory and scientific discrepancies, which were mainly addressed through amendment of the testing documentation by the Marketing-authorisation holders concerned.
Maltese: L-investigazzjonijiet żvelaw xi diskrepanzi regolatorji u xjentfiċi, li primarjament ġew indirizzati permezz ta' l-emenda tad-dokumentazzjoni ta' l-ittestjar mid-detenturi ta' l-awtorizzazzjoni għal tqegħid fis-suq kkonċernati.
English: PIM (Product Information Management - a process that supports the electronic exchange of product information between applicants and the EMEA, as well as the review of this information).
Maltese: PIM (Ġestjoni ta' Informazzjoni dwar il-Prodott - proċess li jappoġġja l-iskambju elettroniku ta' informazzjoni dwar il-prodott bejn l-applikanti u l-EMEA, kif ukoll ir-reviżjoni ta' din linformazzjoni).
English: ** A new method has been used as of 2006 to present the number of ICSRs received/expected over time.
Maltese: ** Mill-2006 ġie użat metodu ġdid biex jiġu ippreżentati n-numru ta' ICSRs riċevuti/mistennija fuq medda ta' żmien.
English: Anti-infectives, which include medicines for the treatment of HIV/AIDS infections, and cardiovascular products were the two next most-represented therapeutic groups, overtaking alimentary-tract and central-nervous-system treatments that held these positions in
Maltese: L-anti-infettivi, li jinkludu mediċini għall-kura ta' linfezzjonijiet HIV/AIDS, u prodotti kardjovaskulari kienu ż-żewġ gruppi l-aktar irrappreżentati li jmiss, li ħadu post il-kura tal-kanal alimentari u tas-sistema nervuża ċentrali, li żammew dawn ilpożizzjonijiet fl-2005.
English: 1.1 Improving the safety of medicines
Maltese: 1.1 Titjib fis-sigurtà tal-mediċini
English: Cardiovascular
Maltese: SPEZZJONIJIET
English: Parallel-distribution notifications of a change, 2004-2006
Maltese: Notifiki ta' distribuzzjoni parallela ta' bidla, 2004-2006
English: In 2006, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a total of 13 positive opinions for initial marketing-authorisation applications.
Maltese: Fl-2006, il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) adotta total ta' 13-il opinjoni pożittiva għal applikazzjonijiet ta' awtorizzazjoni għal tqegħid fis-suq.
English: The Agency's policy on fee reductions for orphan medicines was amended in 2006 to take into account the increasing number of fee-reduction requests being received.
Maltese: Il-politika ta' l-Aġenzija dwar tnaqqis ta' drittijiet għal mediċini orfni ġiet emendata fl-2006 biex tieħu kunsiderazzjoni tan-numru dejjem jiżdied ta' talbiet għal tnaqqis ta' drittijiet li ġew riċevuti.
English: The Agency received 79 applications for initial marketing authorisation in 2006, including one concerning a medicinal product intended exclusively for use outside the EU.
Maltese: Fl-2006 l-Aġenzija rċeviet 79 applikazzjoni għal awtorizzazzjoni għal tqegħid fis-suq inizjali, inkluż waħda li tikkonċerna prodott mediċinali maħsub esklussivament għall-użu barra l-UE.
English: Adopted a reflection paper on the use of quinolones and fluoroquinolones in the EU, critically reviewing recent data on their use and potential impact on human and animal health.
Maltese: Adottat dokument ta' riflessjoni dwar l-użu ta' quinolones u fluoroquinolones fl-EU, billi rrevediet b'mod kritiku data riċenti dwar l-użu tagħhom u l-impatt potenzjali fuq is-saħħa talbniedem u ta' l-annimali.
English: The number of post-authorisation opinions adopted was also significantly higher (20%) than in the previous year.
Maltese: In-numru ta' opinjonijiet ta' wara l-awtorizzazzjoni adottati kien sinifikament ogħla (20%) mis-sena ta' qabel.
English: Work is required in order to complete the data warehouse and business intelligence functionality, sophisticated signal detection, signal tracking, and implementation of the access policies with regard to all stakeholders.
Maltese: Hija meħtieġa ħidma sabiex jitlesta l-maħżen tad-data u l-funzjonalità ta' l-intelliġenza tan-negozju, ittkixxif ta' sinjali sofistikat, it-traċċar ta' sinjali, u l-implimentazzjoni tal-politika ta' aċċess firrigward tal-partijiet interessati kollha.
English: The average overall time required for approval of a marketing-authorisation application decreased significantly in 2006, with marked reductions compared to 2005 in the average times for the assessment, post-opinion and decision phases of the procedure.
Maltese: Iż-żmien globali meħtieġ għall-approvazzjoni ta' applikazzjoni ta' awtorizzazzjoni għal tqegħid fissuq naqas b'mod sinjifikanti fl-2006, bi tnaqqis sostanzjali imqabbel ma' l-2005 fil-perjodi ta' żmienijiet medji għall-fażijiet ta' valutazzjoni, ta' wara l-opinjoni u tad-deċiżjoni tal-proċedura.
English: The Agency managed record numbers of initial marketing-authorisation applications and postauthorisation variation applications, and of requests for scientific advice, parallel-distribution notifications and certificates.
Maltese: L-Aġenzija amministrat numri rekord ta' applikazzjonijiet inizjali għal awtorizzazzjoni għal tqegħid fis-suq, u ta' talbiet għal parir xjentifiku, notifiki ta' distribuzzjoni parallela u ċertifikati.
English: Revising the mandate of the Agency's Pharmacovigilance Working Party for medicines for veterinary use, making it the core scientific group for monitoring pharmacovigilance matters relating to veterinary medicinal products authorised in the EU.
Maltese: Ir-reviżjoni tal-mandat tal-Grupp ta' Ħidma dwar il-Farmakoviġilanza ta' mediċini għall-użu veterinarju ta' l-Aġenzija, biex isir il-grupp xjentifiku prinċipali għall-monitoraġġ ta' kwistjonijiet ta' farmakoviġilanza fir-rigward ta' prodotti mediċinali veterinarji awtorizzati fl-UE.
English: Number of inspections, 2004-2006
Maltese: Numru ta' spezzjonijiet, 2004-2006
English: Twelve of the recalls were ‘class 2' recalls, which relate to defects that could cause illness or mistreatment, and the remaining 9 were classified as ‘class 3' recalls, which are not associated with serious public-health hazards.
Maltese: Tnax mis-sejħiet lura kienu sejħiet lura tal-‘klassi 2', li jikkonċernaw difetti li jistgħu jikkaġunaw mard jew trattament ħażin, u d-9 li jifdal ġew klassifikati bħala sejħiet lura tal-‘klassi 3', li m'humiex assoċjati ma' perikli serji għas-saħħa pubblika.
English: These included the first ‘opinions on any scientific matter', under Article 5(3) of Regulation (EC) No 726/2004.
Maltese: Dawn inkludew l-ewwel ‘opinjonijiet dwar kwalunkwe materja xjentifka', taħt l-Artikolu 5(3) tar-Regolament (KE) Nru 726/2004.
English: By the end of the year, 161 sponsors of clinical trials being conducted in the European Economic Area were reporting suspected unexpected serious adverse reactions to the EudraVigilance Clinical Trial Module (EVCTM).
Maltese: Sa tmiem is-sena, 161 sponsor ta' provi kliniċi li qegħdin jitwettqu fiż-Żona Ekonomika Ewropea kienu qed jirrappurtaw reazzjonijiet mhux mixtieqa serji u mhux mistennija għall-Modulu ta' Prova
English: The scientific advice procedure has been improved and is used increasingly by sponsors of medicinal products.
Maltese: Ilproċedura ta' parir xjentifiku tjiebet u hija użata dejjem aktar minn sponsors ta' prodotti mediċinali.
English: In December 2006, the EMEA Management Board further extended the pilot scheme for free scientific advice for veterinary medicines for minor uses and minor species.
Maltese: F'Diċembru 2006, il-Bord ta' Tmexxija ta' l-EMEA estenda ulterjorment l-iskema pilota għal pariri xjentifiċi b'xejn għal mediċini veterinarji għal indikazzjonijiet minuri u speċi minuri.
English: To prepare a strategy for establishing a pan-European paediatric-research network, the EMEA met with existing networks in the EU.
Maltese: Biex tiġi ppreparata strateġija għat-twaqqif ta' network ta' riċerka pedjatrika, l-EMEA iltaqgħet ma' networks eżistenti fl-UE.
English: Immunology
Maltese: Immunolo?ija
English: By the end of 2006, 160 EPAR summaries had been published.
Maltese: Sa l-aħħar ta' l-2006, ġew ippubblikati 160 ġabra fil-qosor ta' l-EPAR.
English: A total of 10 referrals were made to the CVMP in 2006 in the framework of the mutual-recognition procedure.
Maltese: Saru total ta' 10 riferimenti lis-CVMP fl-2006 fil-qafas tal-proċedura ta' għarfien reċiproku.
English: Number of quality defects reported,
Maltese: Numru ta' difetti fil-kwalita` li gew irrapportati,
English: Orphan-designation procedures, 2004-2006
Maltese: Pro?eduri ta' iklassifikar ta' prodotti orfni, 2004-2006
English: The CHMP concluded that these medicinal products continue to offer effective protection against hepatitis B, but recommended some changes to the prescribing information.
Maltese: Is-CHMP ikkonkluda li dawn il-prodotti mediċinali jkomplu joffru protezzjoni effettiva kontra l-epatite tat-tip B, iżda rrakkomanda xi bidliet għallinformazzjoni ta' preskrizzjoni.
English: Of the 738 reports received: 638 related to suspected adverse reactions in animals and 100 to reactions in humans.
Maltese: 380 kellhom x'jaqsmu ma' reazzjonijiet mhux mixtieqa suspettati fil-klieb. 200 kelhom x'jaqsmu ma' reazzjonijiet mhux mixtieqa suspettati fil-qtates.
English: Marketing-authorisation holders started reporting electronically and implementation plans for full electronic reporting were being finalised by major veterinary pharmaceutical companies.
Maltese: Id-detenturi ta' awtorizzazzjoni għal tqegħid fis-suq bdew jirrappurtaw b'mod elettroniku u pjanijiet għall-implimentazzjoni ta' rapportaġġ eletttroniku komplet bdew jiġu finalizzati minn kumpaniji farmaċewtiċi veterinarji ewlenin.
English: The CHMP concluded that it cannot be excluded that non-selective NSAIDs may be associated with a small increase in the absolute risk for thrombotic events, especially when used at high doses for long-term treatment.
Maltese: Is-CHMP ikkonkluda li ma jistax jiġi eskluż li NSAIDs mhux selettivi jistgħu jiġu assoċjati ma' żieda żgħira fir-riskju assolut għal avvenimenti trombotiċi, speċjalment meta użati f'dożi għoljin f'kura għal perjodu twil.
English: 4.2 Sampling and testing
Maltese: 3.2 Valutazzjoni inizjali
English: One cephalosporin for treatment of specific skin, soft-tissue and urinary-tract infections in cats and dogs.
Maltese: Cephalosporin wieħed għall-kura ta' infezzjonijiet speċifiċi fil-ġilda, fit-tessut artab u fil-qasam urinarju tal-qtates u l-klieb.
English: Line-extension applications Type-II variation applications Type-I variation applications
Maltese: Applikazzjonijiet ta' estenzjoni tal-linja Applikazzjonijiet ta' varjazzjoni tat-tip-II Applikazzjonijiet ta' varjazzjoni tat-tip-I
English: The centralised procedure is compulsory for all medicinal products for human and animal use derived from biotechnology processes.
Maltese: Il-proċedura ċentralizzata hija obbligatorja għall-prodotti mediċinali kollha għall-użu tal-bniedem u fl-annimali mnissla minn proċessi bijoteknoloġiċi.
English: Of the post-authorisation opinions adopted in 2006 for type-II variations, 79 related to special warnings and precautions for use.
Maltese: Fost l-opinjonijiet ta' wara l-awtorizzazzjoni adottati fl-2006 għall-varjazzjonijiet tat-tip-II, 79 kienu relatati ma' twissijiet speċjali u prekawzjonijiet għall-użu.