FrancophonIA/ELRC3.0 huggingface dataset:
English: Medical conditions affecting adults only Medical conditions affecting both children and adults Medical conditions affecting children only
Maltese: Kondizzjonijiet medici li jolqtu lill-adulti biss Kondizzjonijiet medici li jolqtu kemm lit-tfal kif ukoll lill-adulti Kondizzjonijiet medici li jolqtu lit-tfal biss
English: Oncology
Maltese: Onokologija
English: Medicinal products of notable public-health interest that received a positive opinion from the CHMP in 2006 included:
Maltese: Prodotti mediċinali ta' interess sinifikanti għas-saħħa pubblika li rċevew opinjoni pożittiva mis-CHMP fl-2006 inkludew:
English: Among the positive opinions adopted, 11 concerned new orphan products and 2 concerned similar biological (biosimilar) products containing human DNA-recombinant growth hormone.
Maltese: Fost l-opinjonijiet pożittivi adottati, 11 kienu għal prodotti orfni ġodda u 2 għal prodotti bijoloġiċi simili (bijosimili) li fihom l-ormon tat-tkabbir uman permezz tad-DNA rikombinanti.
English: Cyprus
Maltese: Cipru, 0
English: Anti-infective
Maltese: Anti-infettivi
English: EudraNet (secure communication between stakeholders in the European Medicines Regulatory Network).
Maltese: EudraNet (komunikazzjoni sigura bejn il-partijiet interessati fin-Network Regolatorju Ewropew tal-Mediċini).
English: In 2006, the EMEA received 64 quality-defect reports concerning human medicinal products and 3 quality-defect reports concerning veterinary medicinal products.
Maltese: Fl-2006, l-EMEA rċeviet 64 rapport ta' difetti fil-kwalità li kkonċernaw prodotti mediċinali għall-użu tal-bniedem u 3 rapporti ta' difetti fil-kwalità li jikkonċernaw prodotti mediċinali veterinarji.
English: This included a review of results from: risk-management, internal and external audits; self-assessments related to internal control standards; self-assessments as part of the Benchmarking of European Medicines Agencies (BEMA); the environmental analysis 2006; and the 2006 staffmotivation survey.
Maltese: Dan inkluda reviżjoni tar-riżultati minn: ġestjoni tar-riskji, verifiki interni u esterni; valutazzjonijiet interni relatati ma' l-istandards ta' kontroll interni ; valutazzjonijiet interni bħ mill-Benchmarking ta' l-Aġenziji Ewropej tal-Mediċini (BEMA); l-analiżi ambjentali fl-2006; u listħarriġ dwar il-motivazzjoni tal-persunal.
English: Centrally authorised tacrolimus-containing medicinal products (Protopic and Protopy), in relation to a potential risk of skin cancer and lymphoma.
Maltese: Prodotti mediċinali awtorizzati ċentralment li fihom it-tacrolimus (Protopic u Protopy), firrigward ta' riskju potenzjali tal-kanċer tal-ġilda u l-limfoma.
English: Estonia
Maltese: Estensjonijiet
English: The CHMP adopted 51 positive opinions and 4 negative opinions on initial marketing-authorisation applications evaluated in 2006.
Maltese: Is-CHMP adottat 51 opinjoni pożittiva u 4 opinjonijiet negattivi dwar applikazzjonijiet inizjali ta' awtorizzazzjoni għal tqegħid fis-suq valutati fl-2006.
English: Contra-indications, class labelling and warnings
Maltese: Kontra-indikazzjonijiet, tikkettar ta' klassi u twissijiet
English: The Committee on Herbal Medicinal Products (HMPC) finalised Community herbal monographs in 2006 for valerian root, linseed, ispaghula husk, ispaghula seed, psyllium seed, senna pods, senna leaf, frangula bark and aloes (cape and barbados).
Maltese: Fl-2006 il-Kumitat dwar Prodotti Mediċinali magħmula mill-Ħxejjex (HMPC) iffinalizza monografiji Komunitarji dwar ħxejjex għall-għerq tal-valerian, kittien, fosdqa ta' l-ispaghula, żerriegħa ta' lispaghula, żerriegħa tal-psyllium, miżwed tas-senna, werqa tas-senna, qoxra tas-siġra tal-frangula u aloes (cape u barbados).
English: EU telematics strategy
Maltese: Strategija telematika ta' l-UE
English: Preparing guidance on paediatric pharmacovigilance.
Maltese: Tħejjija ta' gwida dwar il-farmakoviġilanza pedjatrika.
English: The network is in place, connecting regulatory authorities in the European Economic Area, including the two new EU Member States, Bulgaria and Romania.
Maltese: In-network huwa operattiv, jgħaqqad lill-awtoritijiet regolatorji fiż-Zona Ekonomika Ewropea, inkluż iż-żewġ Stati Membri ta' l-UE, il-Bulgarija u r-Rumanija.
English: Article 36
Maltese: L-Artikolu 36
English: EudraCT (database of information on the content, commencement and termination of clinical trials in the EU).
Maltese: EudraCT (database ta' informazzjoni dwar il-kontenut, il-bidu u t-tmiem ta' provi kliniċi fl-UE).
English: There were 25 applications relating to the more complex type-II variations.
Maltese: Kien hemm 25 applikazzjoni fir-rigward ta' varjazzjonijiet aktar komplessi tat-tip-II.
English: EU ADRs Non-EU ADRs
Maltese: ADRs ta' l-UE ADRs li mhux mill-UE
English: A new system of revenue (invoicing) was introduced and implemented successfully.
Maltese: Kienet introdotta u implimentata b'suċċess sistema ġdida ta' fattura (invoicing).
English: Other revenue SME contribution Telematics strategy Orphan drug contribution Total fee revenue Basic EU contribution
Maltese: Strategija telematika Kontribut ghal medicini orfni Dhul mill-mizati totali Kontribut baziku ta' l-UE
English: Building and equipmentrelated expenditure (including EU telematics)
Maltese: Infiq relatat mal-bini u ttaghmir (inkluż telematiċi ta' l-UE)
English: By the end of the year, a total of 26 national competent authorities (NCAs) were reporting electronically to EudraVigilance, as were 201 marketing-authorisation holders.
Maltese: Sa tmiem is-sena, total ta' 26 awtorita nazzjonali kompetenti (NCAs) kienu qed jirrappurtaw b'mod elettroniku lill-EudraVigilance, kif kienu qed jagħmlu 201 detentur ta' awtorizzazzjoni għal tqegħid fis-suq.
English: Applications withdrawn prior to opinion Negative opinions
Maltese: Opinjonijiet pozittivi Applikazzjonijiet irtirati qabel l-opinjoni Opinjonijiet negattivi
English: Article 31
Maltese: L-Artikolu 31
English: A new treatment option for type-2 diabetes mellitus, introducing a new class of medicinal products called incretin mimetics.
Maltese: Għażla ġdida għal kura tad-dijabete mellitus tat-tip-2, li tintroduċi klassi ġdida ta' prodotti mediċinali msejħa incretin mimetics.
English: Efforts to improve transparency of regulatory activity
Maltese: Sforzi biex titjieb it-trasparenza ta' l-attività regolatorja
English: The Agency systematically provided comprehensive information in the form of press releases and question-and-answer documents to explain scientific opinions in a number of areas, including the safety of medicines, new types of applications, new technological advances and the approval procedure for pandemic flu vaccines, as well as general question-and-answer documents to help with communication on subjects such as compassionate use or generic and biosimilar medicines.
Maltese: B'mod sistematiku, l-Aġenzija pprovdiet informazzjoni komprensiva fil-forma ta' stqarrijiet għallistampa u dokumenti b'mistoqsija u tweġiba biex tispjega opinjonijiet xjentifiċi f'numru ta' oqsma, inklużi s-sigurtà tal-mediċini, tipi ġodda ta' applikazzjonijiet, avvanzi teknoloġiċi ġodda u l-proċedura ta' approvazzjoni għat-tilqim ta' l-influwenza pandemika, kif ukoll dokumenti ġenerali b'mistoqsija u tweġiba, li jgħinu fil-komunikazzjoni dwar suġġetti bħall-użu kompassjonali (compassionate use) jew mediċini ġeneriċi u bijosimili.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) finalised guidelines for quality-, safety- and efficacy-testing of such products, and published for consultation a similar guideline regarding immunological products.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) iffinalizza linji gwida għall-ittestjar tal-kwalità, is-sigurtà u l-effikaċja ta' tali prodotti, u ppubblikat linja gwida simili għallkonsultazzjoni fir-rigward ta' prodotti immunoloġiċi.
English: Orphan drug fund
Maltese: Fond tad-Droga Orfni
English: More than 95% of marketing-authorisation holders of centrally authorised products are now in production with the system.
Maltese: Aktar minn 95% taddetenturi ta' awtorizzazzjoni għal tqegħid fis-suqta' prodotti awtorizzati ċentralment issa qegħdin fi produzzjoni mas-sistema.
English: Fifty-two periodic safety-update reports (PSURs) were received in 2006 for centrally authorised products.
Maltese: Fl-2006 ġew riċevuti 52 rapport perjodiku ta' aġġornament dwar is-sigurtà (PSURs) għal prodotti awtorizzati ċentralment.
English: Detection of pharmacovigilance signals
Maltese: Tkixxif ta' sinjali ta' farmakoviġilanza
English: The good progress observed in 2005 with EudraVigilance continued in 2006.
Maltese: Il-progress tajjeb osservat fl-2005 fl-EudraVigilance kompla fl-2006.
English: A total of 1,588 applications for variations and line extensions were received in 2006 - an increase of 31% over the total received in 2005.
Maltese: Total ta' 1,588 applikazzjonijiet għal varjazzjonijiet u estenzjonijiet tal-linja ġew riċevuti fl-2006żieda ta' 31% fuq it-total riċevut fl-2005.
English: Initial parallel-distribution notifications, 2004-2006
Maltese: Notifiki inizjali ta' distribuzzjoni parallela, 2004-2006
English: Proposed risk-management actions, including a recommendation for harmonised prudent-use guidance in the product literature of all (fluoro)quinolone-containing veterinary medicines for food-producing animals.
Maltese: Ipproponiet azzjonijiet għall-ġestjoni tar-riskji, inkluż rakkomandazzjoni għal gwida armonizzata b'użu prudenti fil-letteratura tal-prodott tal-mediċini veterinarji kollha li jinkludu l(fluoro)quinolone għall-annimali għal konsum.
English: The base system is in place.
Maltese: Is-sistema bażi hija operattiva.
English: Over 145 companies, including 6 veterinary companies, submitted applications for SME status to the Agency.
Maltese: 'Il fuq minn 145 kumpanija, inklużi 6 kumpaniji veterinarji, ippreżentaw l-applikazzjonijiet għallistatus ta' SME lill-Aġenzija.
English: The cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) stemming from new clinical and pharmacoepidemiological study data.
Maltese: Is-sigurtà kardjovaskulari ta' mediċini anti-infjammatorji mhux sterojdali mhux selettivi (NSAIDs) li toriġina minn data ġdida ta' studju kliniku u farmakoepidemoloġiku.
English: (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: (Tilqima pandemika bi prova m'hijiex intenzjonata għall- ħżin, iżda tista' tintuża biex tgħaġġel id-disponibbiltà ta' tilqima finali fil-każ ta' pandemija, ladarba tiġi identifikata l-istrain pandemika.)
English: New applications (by medicinal product) New applications (by active substance)
Maltese: Applikazzjonijiet godda (bi prodott medicinali) Applikazzjonijiet godda (b'sustanza attiva)
English: Regulation (EC) No 1901/2006 on medicinal products for paediatric use.
Maltese: Regolament (KE) Nru 1901/2006 dwar prodotti mediċinali għal użu pedjatriku.
English: As part of its implementation of EU pharmaceutical legislation, the EMEA launched a first version of EudraPharm - a new medicines-information database for the EU - on 6 December 2006.
Maltese: Bħala parti mill-implimentazzjoni tagħha tal-leġiżlazzjoni farmaċewtika ta' l-UE, l-EMEA nediet lewwel verżjoni ta' EudraPharm - database ġdid ta' informazzjoni dwar il-mediċini għall-UE - fis-6 ta' Diċembru 2006.
English: A particularly high number of extensions of indication - 41 (46% more than in 2005) - were introduced in 2006, providing additional treatment options for patients.
Maltese: Fl-2006 ġew introdotti numru partikolarment għoli ta' estenzjonijiet ta' l-indikazzjoni - 41 (46% aktar milli fl-2005) - li pprovdew għażliet addizzjonali ta' kura għall-pazjenti.
English: The number of procedures for arbitrations, referrals and Article 5(3) opinions started in 2006 was 79% greater than in 2005.
Maltese: In-numru ta' proċeduri għal arbitraġġ, referenzi u opinjonijiet taħt l-Artikolu 5(3) li bdew fl-2006 kien 79% ikbar milli fl-2005.
English: 3.3 Maximum residue limits Fewer maximum-residue-limit applications submitted than expected
Maltese: 3.3 Limiti massimi ta' residwi
English: In 2006, information on 14 withdrawals and 7 refusals was published.
Maltese: Fl-2006, ġiet ippubblikata informazzjoni dwar 14-il irtirar u 7 rifjuti.
English: Adoption of several proposals for greater transparency.
Maltese: L-adozzjoni ta' diversi proposti b'riżq trasparenza ikbar.
English: Further progress with EudraVigilance
Maltese: Progress ulterjuri ta' l-EudraVigilance
English: In particular, the total number of type-II variations (including extensions of indication) finalised during 2006 was 35% greater.
Maltese: B'mod partikolari, in-numru totali ta' varjazzjonijiet tat-tip-II (inkluż estenzjonijiet ta' lindikazzjoni) iffinalizzati matul l-2006 kien 35% akbar.
English: Other 1% Netherlands
Maltese: L-Olanda, 10 Malta, 1
English: Preparing for the establishment of the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance (ENCePP) - a network of academic centres for intensive drug monitoring.
Maltese: Il-preparazzjoni għat-twaqqif ta' Network Ewropew ta' Ċentri tal-Farmakoepidemoloġija u lFarmakoviġilanza (ENCePP) - network ta' ċentri akkademiċi għall-monitoraġġ intensiv ta' mediċini.
English: Eight initial marketing-authorisation applications were received, 5 of which were for pharmaceuticals and 3 for immunologicals.
Maltese: Ġew riċevuti tmien applikazzjonijiet ta' awtorizzazzjoni għal tqegħid fis-suq, 5 minnhom kienu għal farmaċewtiċi u 3 għal immunoloġiċi.
English: The same review was conducted for non-centrally authorised pimecrolimus-containing medicinal products (Elidel) under Article 31 of Directive 2001/83/EC, with the same outcome.
Maltese: L-istess reviżjoni twettqet għal prodotti mediċinali li mhumiex awtorizzati ċentralment li jinkludu l-pimecrolimus (Elidel) taħt l-Artikolu 31 tad-Direttiva 2001/83/KE, bl-istess eżitu.
English: The 2006 programme for sampling and testing included 32 centrally authorised products.
Maltese: Il-programm ta' l-2006 għal teħid ta' kampjuni u ttestjar inkluda 32 prodott awtorizzat ċentralment.
English: Started Finalised Started Finalised Started Finalised
Maltese: Mibdija Finalizzata Mibdija Finalizzata Mibdija Finalizzata
English: The Agency reviewed 80% of the RMPs submitted as part of new applications.
Maltese: L-Aġenzija rrevediet 80% ta' l-RMPs sottomessi bħala parti mill-applikazzjonijiet il-ġodda.
English: Stimulating availability of veterinary medicines for rare uses and species
Maltese: Stimulazzjoni tad-dispobibbiltà ta' mediċini veterinarji għal indikazzjonijiet u speċi rari
English: GXP means 'good clinical practice' (GCP), 'good manufacturing practice' (GMP) and 'good laboratory practice' (GLP) collectively.
Maltese: GXP tfisser ‘prattika klinika tajba' (GCP), ‘prattika tajba ta' manifattura' (GMP) u ‘prattika tajba tal-laboratorju tajba (GLP) ilkoll flimkien.
English: Other
Maltese: Jiem
English: Continuing its activities in the area of pandemic-influenza preparedness, the EMEA: developed a pandemic-influenza crisis-management plan; held a meeting of the Joint EMEA-Industry Task-Force; strengthened contacts with the European Commission Directorate-General for Health and Consumer Protection and with the European Centre for Disease Prevention and Control; had regular communications with the US Food and Drug Administration (FDA) to discuss issues of common interest.
Maltese: Fit-tkomplija ta' l-attivitajiet tagħha fil-qasam tat-tħejjija għall-influwenza pandemika, l-EMEA: żviluppat pjan għall-ġestjoni ta' kriżi għall-influwenza pandemika; żammet laqgħa tal-Forza taxXogħol konġunta bejn l-EMEA u l-Industrija; saħħet kuntatti mad-Direttorat Ġenerali għallProtezzjoni tas-Saħħa u tal-Konsumatur tal-Kummissjoni Ewropea u maċ-Ċentru Ewropew dwar ilPrevenzjoni u l-Kontroll tal-Mard; żammet komunikazzjonijiet regolari ma' l-Amministrazzjoni ta' lIstati Uniti dwar l-Ikel u d-Droga (FDA) biex tiddiskuti kwistjonijiet ta' interess komuni.
English: In the veterinary sphere, the EMEA held a very successful Infoday with IFAH-Europe, in November, at which a number of topics were intensely debated, including benefit-risk assessment, user-safety guidelines and environmental-risk assessment.
Maltese: Fil-qasam veterinarju, l-EMEA organizzat b'suċċess ġurnata ta' informazzjoni mal-IFAH-Ewropa, f'Novembru, li matulha ġew diskussi b'mod intensiv numru ta' suġġetti, inkluż il-valutazzjoni tarriskju u l-benefiċċju, il-linji gwida għas-sigurtà ta' l-utent u l-valutazzjoni dwar ir-riskji ambjentali.
English: The CHMP adopted positive opinions in 3 conditional-approval procedures (concerning products for treatment of cancer, epilepsy and HIV infection) and approved a further 3 products under exceptional circumstances (concerning 1 product for cancer, 1 for an enzyme-deficiency disease, and 1 pandemicinfluenza mock-up vaccine).
Maltese: Is-CHMP adottat opinjonijiet pożittivi fi 3 proċeduri ta' approvazzjoni kondizzjonali (dwar prodotti għall-kura tal-kanċer, l-epilessija u l-infezzjoni ta' l-HIV) u approvat 3 prodotti oħra taħt ċirkostanzi eċċezzjonali (dwar prodott wieħed għall-kanċer, wieħed għal marda tan-nuqqas ta' l-enżimi, u tilqima bi prova ta' l-influwenza pendemika).
English: Certificate requests,
Maltese: Talbiet ghal certifikati,
English: Further progress was made with regard to signal-detection in EudraVigilance through: implementing a new data-analysis system; drafting guidance on the use of statistical signal-detection methods in the data-analysis system; and initiatives undertaken to address identified problems in relation to compliance with expedited reporting and the quality of the submitted data.
Maltese: Sar progress ulterjuri fir-rigward tat-tkixxif ta' sinjali fil-EudraVigilance permezz ta': limplimentazzjoni ta' sistema ġdida għall-analiżi tad-data; it-tfassil ta' gwida dwar l-użu ta' metodi statistiċi ta' tkixxif ta' sinjali fis-sistema għall-analiżi tad-data; u inizjattivi mwettqa biex jindirizzaw problemi identifkati fir-rigward tal-konformità ma' rappurtar mgħaġġel u l-kwalità ta' data ppreżentata.
English: 2.7 Herbal medicines Community herbal monographs
Maltese: 2.1 Klassifikar bħala mediċini orfni
English: For the third consecutive year, more than one hundred applications were received for the designation of orphan medicinal products: a total of 104 applications were submitted.
Maltese: Għat-tielet sena konsekuttiva, ġew riċevuti iktar minn mitt applikazzjoni għall-iklassifikar ta' prodotti mediċinali orfni: ġew ippreżentati total ta' 104 applikazzjoni.
English: Applications for extension/modification of maximum residue limits, 2004-2006
Maltese: Applikazzjonijiet ghallestensjoni/modifikazzjoni ta' limiti massimi ta' residwu, 2004-2006
English: 117 companies from 17 countries across the EU were assigned SME status, including an encouragingly high number of micro enterprises (24%), many of which were university spin-off companies.
Maltese: 117-il kumpanija minn 17-il pajjiż madwar l-UE ġew assenjati status ta' SME, inkluż numru għoli inkoraġġanti ta' intrapriżi ta' daqs żgħir ħafna (24%), li ħafna minnhom kienu kumpaniji li oriġinaw f'Universitajiet.
English: Arbitration and Community referrals started
Maltese: Arbitragg u riferimenti Komunitarji mibdija
English: The HMPC also released for public consultation 5 new draft Community herbal monographs, for aniseed, anis oil, bitter fennel fruit, sweet fennel fruit and bitter-fennel-fruit oil.
Maltese: L-HMPC ħareġ għall-konsultazzjoni pubblika 5 abbozzi ġodda ta' monografiji Komunitarji dwar ħxejjex għaż-żerriegħa tal-ħlewwa, żejt ta' l-anis, frott tal-bużbież morr , frott tal-bużbież ħelu u żejt tal-frott tal-bużbież morr .
English: Management and internal-control systems are part of EMEA governance and are consolidated in an integrated management system at the Agency.
Maltese: Is-sistemi ta' ġestjoni u kontroll intern huma parti mir-responsabbiltajiet tat-t huma kkonsolidati f'sistema ta' ġestjoni integrata fl-Aġenzija.
English: COMP opinions by therapeutic area, 2006
Maltese: Opinjonijiet tal-COMP skond il-qasam terapewtiku, 2006
English: Submitted
Maltese: Ipprezentati
English: The EMEA adopted the first positive opinion for a pandemic-influenza ‘mock-up' vaccine in December 2006.
Maltese: F'Diċembru ta' l-2006, l-EMEA adottat l-ewwel opinjoni pożittiva għal tilqima bi prova (mock-up) ta' l-influwenza pandemika.
English: Applications are submitted directly to the EMEA.
Maltese: L-applikazzjonijiet huma sottomessi direttament lill-EMEA.
English: EudraVigilance (web-based information system to support the pharmacovigilance obligations laid down by Community legislation).
Maltese: EudraVigilance (sistema ta' informazzjoni li titħaddem fuq il-web biex tappoġġja l-obbligi ta' farmakoviġilanza stabbiliti mil-leġiżlazzjoni Komunitarja).
English: Expedited reports on suspected adverse reactions, 2004-2006
Maltese: Rapporti mghaggla dwar reazzjonijiet mhux mixtieqa suspettati, 2004-2006
English: All initial evaluations were carried out within the 210-day regulatory time limit.
Maltese: Il-valutazzjonijiet inizjali kollha twettqu fi ħdan il-limitu ta' żmien regolatorju ta' 210 jum.
English: EudraPharm (database of medicinal products authorised in the European Union to support regulatory activities and to make information on medicinal products available to the public).
Maltese: EudraPharm (database ta' prodotti mediċinali awtorizzati fl-Unjoni Ewropea biex tappoġġja attivitajiet regolatorji u biex tagħmel disponibbli għall-pubbliku l-informazzjoni dwar prodotti mediċinali).
English: New applications for maximum residue limits, 2004-2006
Maltese: Applikazzjonijiet godda ghal limiti massimi ta' residwu, 2004-2006
English: The overall number of applications for variations to marketing authorisations received in 2006 was lower than in 2005, despite the greater number of centrally authorised products on the market.
Maltese: In-numru globali ta' applikazzjonijiet għal varjazzjonijiet għal awtorizzazzjonijiet għal tqegħid fis-suq riċevuti fl-2006 kien inqas minn fl-2005, minkejja numru ikbar ta' prodotti awtorizzati ċentralment fis-suq.
English: The scientific-advice procedure was streamlined to allow finalisation within 40 days (up to a maximum of 70 days), whereas the previous procedure could take up to 100 days.
Maltese: Il-proċedura tal-pariri xjentifiċi ġiet aġġornata biex tippermetti finalizzazzjoni fi żmien 40 jum (sa massimu ta' 70 jum), filwaqt li l-proċedura preċedenti setgħat tieħu sa 100 jum.
English: The CVMP further reviewed the safety of Cox-2 inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) for use in veterinary medicine as a result of the conclusion of the review of concerns related to human use of these substances.
Maltese: Is-CVMP kompliet tirrevedi s-sigurtà ta' l-inibituri tat-tip Cox-2 u l-mediċini anti-infjammatorji mhux sterojdali (NSAIDs) għall-użu fil-mediċina veterinarja, bħala riżultat tal-konklużjoni tar-reviżjoni ta' tħassib relatat ma' l-użu ta' dawn is-sustanzi mill-bniedem.
English: One medicinal oxygen intended for oxygen supplementation and as a carrier gas during inhalation anaesthesia.
Maltese: Ossiġenu mediċinali wieħed intenzjonat għal supplementazzjoni ta' ossiġenu u bħala gass li jintuża fil-anestesija minn-nifs.
English: 4.3 Certificates of a medicinal product Main developments in 2006
Maltese: 4.3 Ċertifikati ta' prodott mediċinali Żviluppi prinċipali fl-2006
English: Line extensions Type-II variations Type-I variations
Maltese: Estenzjonijiet tal-linja Varjazzjonijiet tat-tip-II Varjazzjonijiet tat-tip-I
English: Designated orphan medicinal products for the treatment of children and adults, 2004-2006
Maltese: Prodotti medicinali klassifikati bhala orfni ghall-kura tat-tfal u ta' l-adulti, 2004-2006
English: Public-health benefits of medicines recommended for approval in 2006
Maltese: Benefiċċji għas-saħħa pubblika ta' mediċini rakkomandati għall-approvazzjoni fl-2006
English: Use of EU special contribution for orphan medicines, 2006
Maltese: Uzu tal-kontribut specjali ta' l-UE ghall-medicini orfni, 2006