FrancophonIA/ELRC3.0 huggingface dataset:
English: Please ask your doctor for more information about the exact immunosuppressant medicine you will be taking.
Maltese: Jekk jogħġbok staqsi lit-tabib tiegħek għal aktar informazzjoni dwar il-mediċina immunosoppressanti eżatta li tkun qed tieħu.
English: Women of childbearing potential must be advised to use reliable barrier contraception methods in accordance with the guidelines for immunosuppressants for a minimum of 12 months from the start of therapy (9 months following cessation of immunosuppressants).
Maltese: Nisa li jistgħu joħorġu tqal għandhom jiġu avżati biex jużaw metodi affidabbli ta' kontraċezzjoni barriera skont il-linji gwida għal immunosoppressanti għal minimu ta' 12-il xahar mill-bidu ta' terapija (9 xhur wara l-waqfien tal- immunosoppressanti).
English: Local pain or sensitivity may be managed by symptomatic treatment such as administration of local or systemic pain relievers.
Maltese: Uġigħ lokali jew sensittività jistgħu jiġu ġestiti permezz ta' kura sintomatika bħall-għoti ta' sustanzi lokali jew sistemiċi kontra l-uġigħ.
English: From the triglyceride data the 1 x 1012 gc/kg dose appears the most optimal.
Maltese: Mid-dejta dwar it-trigliċeridi, id-doża ta' 1 x 1012 gc/kg tidher l-aqwa.
English: No data on re-administration of Glybera are available, therefore Glybera should not be re-administered.
Maltese: Il-pazjenti kollha kkurati bi Glybera għandhom jiġu rreġistrati fir-reġistru.
English: No interaction studies other than preclinical and clinical studies with mycophenolate mofetil and ciclosporin have been performed.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interezzjoni Ma twettaq l-ebda studju ta' interazzjoni ħlief studji prekliniċi u kliniċi b'mycophenolate mofetil u ciclosporin.
English: • Patients with increased bleeding risk (such as thrombocytopenia) and muscle disease (such as myositis), must not be treated in view of the large number of intramuscular injections
Maltese: • Pazjenti b'riskju ogħla ta' tnixxija ta' demm (bħal tromboċitopenija) u mard tal-muskoli (bħal mijosite), m'għandhomx jirċievu kura minħabba l-għadd kbir ta' injezzjonijiet ġolmuskolu meħtieġa.
English: Cell and tissue donation
Maltese: Donazzjoni taċ-ċelluli u tat-tessut
English: Chills, Injection site pain, Oedema peripheral, Pyrexia
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: 1.2 ml (10 mg/ml) 1 vial
Maltese: Użu għal ġol-vini kunjett (ħġieġ) 1,2 ml (10 mg/ml) kunjett 1
English: 12 mg Concentrate for solution for infusion
Maltese: 12 mg Konċentrat għal soluzzjoni għallinfużjoni
English: EU Member States: 28
Maltese: UE Istati Membri: 28
English: Image credits: European Medicines Agency / Dreamstime.co© European Medicines Agency, 2016.
Maltese: European Medicines Agency / Dreamstime.co© European Medicines Agency, 2016.
English: Clinical trials
Maltese: Provi kliniċi
English: GDP: € 12.9tn
Maltese: PDG: 12.9 triljun euro
English: Telephone +44 (0)20 3660 6000 Send a question via our website www.ema.europa.eu/contact www.ema.europa.eu
Maltese: Send a question via our website www.ema.europa.eu/contact www.ema.europa.eu
English: • Paediatric Committee (PDCO)
Maltese: • Kumitat Pedjatriku (PDCO)
English: Pricing and reimbursement
Maltese: Ipprezzar u rimborż
English: The Veterinary International Conference on Harmonisation (VICH) is the equivalent forum for veterinary medicines.
Maltese: Il-Konferenza Internazzjonali Veterinarja dwar l-Armonizzazzjoni (VICH) hija l-forum ekwivalenti għall-mediċini veterinarji.
English: • Committee for Advanced Therapies (CAT)
Maltese: • Kumitat għat-Terapiji Avvanzati (CAT)
English: Medicines regulatory authorities:
Maltese: Awtoritajiet regolatorji tal-mediċini:
English: Population: >500m
Maltese: Popolazzjoni: 'il fuq minn 500 miljun
English: Official languages:
Maltese: Image credits:
English: • Global outreach - it ensures appropriate collaboration with relevant international partners and promotes the EU regulatory system globally.
Maltese: • ilħuq globali - hi tiżgura kollaborazzjoni adatta ma' sħab internazzjonali rilevanti u tippromwovi s-sistema regolatorja tal-UE globalment.
English: Latvia Lithuania
Maltese: Latvia
English: The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
Maltese: Is-sistema regolatorja Ewropea għall-mediċini hija bbażata fuq netwerk ta' madwar 50 awtorità regolatorja mill-31 pajjiż taż-ŻEE (28 Stat Membru tal-UE flimkien mal-Islanda, il-Liechtenstein u n-Norveġja), il-Kummissjoni Ewropea u l-EMA.
English: • Committee for Orphan Medicinal Products (COMP)
Maltese: • Kumitat għall-Prodotti Mediċinali Orfni (COMP)
English: Different authorisation routes: one set of common rules.
Maltese: Rotot ta' awtorizzazzjoni differenti: sett wieħed ta' regoli komuni.
English: The European Clinical Trials Database (EudraCT) tracks which clinical trials have been authorised in the EU.
Maltese: Il-Bażi ta' Data tal-UE dwar il-Provi Kliniċi (EudraCT) iżżomm rekord ta' liema provi kliniċi ġew awtorizzati fl-UE.
English: All manufacturing and importing licenses are entered into EudraGMDP, the publiclyavailable European database operated by EMA.
Maltese: Il-liċenzji ta' manifattura u ta' importazzjoni jiddaħħlu fl-EudraGMDP, il-bażi ta' data Ewropea disponibbli għall-pubblikku operata mill-EMA.
English: Public hearings
Maltese: Seduti pubbliċi
English: EMA provides public access to reports of suspected side effects for centrally-authorised medicines in the European database of suspected drug-reaction reports.
Maltese: L-EMA tipprovdi aċċess pubbliku għal rapporti ta' effetti sekondarji suspettati għal mediċini awtorizzati ċentralment fil-bażi ta' data Ewropea ta' rapporti dwar reazzjoni suspettata għal droga.
English: The EU regulatory system for medicines
Maltese: Is-sistema regolatorja
English: This website allows users to view all suspected side effect reports submitted to EudraVigilance
Maltese: Dan is-sit web jippermetti lill-utenti jaraw ir-rapporti kollha dwar effetti sekondarji suspettati ppreżentati lill-EudraVigilance.
English: • Committee on Herbal Medicinal Products (HMPC)
Maltese: • Il-Kumitat għall-Prodotti Mediċinali Erbali (HMPC)
English: They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials and the conduct of inspections of medicines' manufacturers and compliance with good clinical practice (GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP).
Maltese: Huma jibbażaw ukoll fuq xulxin għall-iskambju ta' informazzjoni fir-regolamentazzjoni tal-mediċini, pereżempju fir-rigward tar-rappurtar tal-effetti sekondarji tal-mediċini, is-sorveljanza ta' provi kliniċi u t-twettiq ta' spezzjonijiet ta' manifatturi tal-mediċini u l-konformità ma' prassi klinika tajba (PKT), prassi tajba ta' manifattura (PTM), prassi tajba ta' distribuzzjoni (PTD), u prassi farmakoviġilanti tajba (PFT).
English: EMA and many NCAs are also involved in the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of GMP.
Maltese: L-EMA u bosta NCAs huma involuti wkoll fil-Konvenzjoni ta' Spezzjoni Farmaċewtika u l-Iskema ta' Kooperazzjoni fl-Ispezzjoni Farmaċewtika (flimkien imsejħa l-PIC/S), kooperazzjoni internazzjonali mill-qrib bejn l-awtoritajiet ta' spezzjoni farmaċewtika fil-qasam tal-PTM.
English: ICMRA is a voluntary, executive level entity of medicines regulatory authorities worldwide providing strategic coordination, advocacy and leadership.
Maltese: L-ICMRA hija entità volontarja fil-livell eżekuttiv ta' awtoritajiet regolatorji tal-mediċini mad-dinja kollha li tipprovdi koordinazzjoni, rappreżentanza u tmexxija strateġiċi.
English: It is used by NCAs and clinical-trial sponsors to enter information protocols and results of clinical trials.
Maltese: Din tintuża mill-NCAs u minn sponsors ta' provi kliniċi biex jiddaħħlu l-protokolli ta' informazzjoni u r-riżultati ta' provi kliniċi.
English: A strategic forum at the level of global agencies has recently been established - the International Coalition of Medicines Regulatory Authorities (ICMRA).
Maltese: Reċentement ġie stabbilit forum strateġiku fil-livell ta' aġenziji globali - il-Koalizzjoni Internazzjonali ta' Awtoritajiet Regolatorji tal-Mediċini (ICMRA).
English: The CHMP can carry out scientific assessments and give opinions, in cooperation with WHO, on medicines for use exclusively outside the EU.
Maltese: Is-CHMP jista' jwettaq valutazzjonijiet xjentifiċi u jagħti opinjonijiet, f'kooperazzjoni mal-WHO, dwar mediċini għal użu esklussivament barra l-UE.
English: EMA is responsible for the scientific evaluation,
Maltese: L-EMA hija responsabbli għall-evalwazzjoni xjentifika,
English: There are also a number of bilateral cooperation agreements in place that facilitate the exchange of important information on medicines between regulators inside and outside the EU.
Maltese: Jeżistu wkoll għadd ta' ftehimiet ta' kooperazzjoni bilaterali li jiffaċilitaw l-iskambju ta' informazzjoni importanti dwar il-mediċini bejn ir-regolaturi ġewwa u barra l-UE.
English: • Committee for Medicinal Products for Veterinary Use (CMVP)
Maltese: • Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP)
English: Equivalence between Member States' inspectorates is ensured and maintained in a variety of ways, including common legislation, common good manufacturing practice (GMP), common procedures for inspectorates, technical support, meetings, trainings, and internal and external audits.
Maltese: L-ekwivalenza bejn l-ispettorati tal-Istati Membri hija żgurata u miżmuma b'firxa ta' modi, inklużi leġiżlazzjoni komuni, PTM komuni, proċeduri komuni għall-ispettorati, appoġġ tekniku, laqgħat, taħriġ, u awditi interni u esterni.
English: States.
Maltese: Ċeka
English: • Pharmacovigilance Risk Assessment Committee (PRAC)
Maltese: • Il-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam talFarmakoviġilanza (PRAC)
English: This includes vaccines used in the WHO Expanded Programme on Immunization, or for protection against a public health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria or tuberculosis.
Maltese: Dan jinkludi vaċċini użati fil-Programm Imwessa' ta' Tlaqqim tal-WHO, jew għall-protezzjoni kontra marda ta' prijorità ta' saħħa pubblika, kif ukoll mediċini għal mard taħt mira tal-WHO bħall-HIV/AIDS, il-malarja jew it-tuberkulożi.
English: All suspected side effects that are reported by patients and healthcare professionals must be entered into EudraVigilance, the EU web-based information system operated by EMA that collects, manages and analyses reports of suspected side effects of medicines.
Maltese: L-effetti sekondarji suspettati kollha li huma rrappurtati mill-pazjenti u l-professjonisti tal-kura tas-saħħa għandhom jiddaħħlu fl-EudraViġilanza, is-sistema ta' informazzjoni bbażata fuq il-web tal-UE mħaddma mill-EMA li tiġbor, tiġġestixxi u tanalizza rapporti ta' effetti sekondarji suspettati tal-mediċini.
English: The national competent authorities (NCAs), responsible for the regulation of human and veterinary medicines in the EU, coordinate their work in a forum called Heads of Medicines Agencies (HMA).
Maltese: L-awtoritajiet nazzjonali kompetenti (NCAs), responsabbli għar-regolamentazzjoni tal-mediċini għall-użu mill-bniedem u dawk veterinarji fl-UE, jikkoordinaw il-ħidma tagħhom f'forum imsejjaħ Kapijiet tal-Aġenziji tal-Mediċini (HMA, Heads of Medicines Agencies).
English: • Right of initiative - it can propose new or amended legislation for the pharmaceutical sector;
Maltese: • dritt ta' inizjattiva - tista' tipproponi leġiżlazzjoni ġdida jew emendata għas-settur tal-farmaċewtika;
English: Supporting regulatory science outside the EU - the Article 58 procedure
Maltese: L-appoġġ għal xjenza regolatorja barra l-UE - il-proċedura tal-Artikolu 58
English: IT systems which connect all parties in the network facilitate the exchange of information on aspects such as safety monitoring of medicines, authorisation and supervision of clinical trials or compliance with good manufacturing and distribution practices.
Maltese: Sistemi tal-IT li jikkonnettjaw lill-partijiet kollha fin-netwerk jiffaċilitaw l-iskambju ta' informazzjoni dwar aspetti bħall-monitoraġġ ta' sigurtà tal-mediċini, l-awtorizzazzjoni u s-superviżjooni ta' provi kliniċi jew il-konformità ma' prassi tajba ta' manifattura u distribuzzjoni.
English: It can also take EU-wide action when a safety issue has been identified for a nationally authorised product and when harmonised regulatory measures in all MSs are considered necessary following assessment by EMA's PRAC.
Maltese: Tista' tieħu wkoll azzjoni mifruxa mal-UE kollha meta tkun identifikata kwistjoni ta' sigurtà għal prodott awtorizzat nazzjonalment u meta miżuri regolatorji armonizzati fl-Istati Membri kollha huma meqjusa neċessarji wara valutazzjoni mill-PRAC tal-EMA.
English: These data are continuously monitored by EMA and the Member States in order to identify any new safety information.
Maltese: Din id-data hija ssorveljata kontinwament mill-EMA u mill-Istati Membri sabiex tkun identifikata kwalunkwe informazzjoni ġdida relatata mas-sigurtà.
English: • Implementation - it can adopt implementing measures as well as oversee the correct application of EU law on pharmaceuticals;
Maltese: • implimentazzjoni - tista' tadotta miżuri implimentattivi kif ukoll tissorvelja l-applikazzjoni korretta tal-liġi tal-UE dwar il-prodotti farmaċewtiċi;
English: Experts participate in the work of EMA as members of its scientific committees, working parties, scientific advisory groups and other ad hoc advisory groups, or as members of the national assessment teams that evaluate medicines.
Maltese: L-esperti jieħdu sehem fil-ħidma tal-EMA bħala membri tal-kumitati xjentifiċi, tal-gruppi ta' ħidma, tal-gruppi konsultattivi xjentifiċi u ta' gruppi konsultattivi ad hoc oħra tagħha, jew bħala membri tat-timijiet ta' valutazzjoni nazzjonali li jevalwaw il-mediċini.
English: National Competent Authorities
Maltese: Awtoritajiet Nazzjonali Kompetenti
English: Regulatory cooperation and exchange of information with international regulators is also assured through the International Pharmaceutical Regulators' Forum (IPRF).
Maltese: Il-kooperazzjoni regolatorja u l-iskambju ta' informazzjoni ma' regolaturi internazzjonali huma assigurati wkoll permezz tal-Forum ta' Regolaturi Farmaċewtiċi
English: The European Commission and EMA work with the World Health Organization (WHO) on a range of issues, including medicines intended for markets outside the EU (medicines reviewed under EMA's so-called ‘Article 58 procedure'), the quality of medicines and the development of international nonproprietary names.
Maltese: Il-Kummissjoni Ewropea u l-EMA jaħdmu mal-Organizzazzjoni Dinjija tas-Saħħa (WHO) dwar firxa ta' kwistjonijiet, inklużi mediċini maħsuba għal swieq barra l-UE (mediċini analizzati taħt 'l hekk imsejħa “proċedura tal-Artikolu 58” tal-EMA), il-kwalità ta' mediċini u l-iżvilupp ta' ismijiet nonproprjetarji internazzjonali.
English: A European Public Assessment Report, or EPAR, is published for every human or veterinary medicine that has been granted or refused a marketing authorisation following an assessment by EMA.
Maltese: Rapport Pubbliku Ewropew ta' Valutazzjoni jew EPAR, huwa ppubblikat għal kull mediċina umana jew veterinarja li tkun ġiet mogħtija jew miċħuda awtorizzazzjoni ta' kummerċjalizzazzjoni wara valutazzjoni mill-EMA.
English: The regulation of medical devices does not fall within the scope of the European regulatory system for medicines.
Maltese: Ir-regolamentazzjoni ta' apparati mediċi ma taqax fil-kamp ta' applikazzjoni tas-sistema regolatorja Ewropea għall-mediċini.
English: The majority of medicines authorised in the EU do not fall within the scope of the centralised procedure but are authorised by national competent authorities (NCAs) in the Member
Maltese: Il-maġġoranza tal-mediċini awtorizzati fl-UE ma jaqgħux fl-ambitu tal-proċedura ċentralizzata iżda huma awtorizzati minn awtoritajiet kompetenti nazzjonali (AKN) fl-Istati Membri.
English: It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network - a partnership between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA) - works to ensure that patients in the
Maltese: Il-ktejjeb jiddeskrivi kif inhuma awtorizzati u sorveljati l-mediċini1 fl-Unjoni Ewropea (UE) u kif in-netwerk regolatorju Ewropew tal-mediċini - sħubija bejn il-Kummissjoni Ewropea, l-awtoritajiet regolatorji tal-mediċini fl-Istati Membri tal-UE, u ż-Żona Ekonomika Ewropea (ŻEE) u l-Aġenzija Ewropea għall-Mediċini (EMA) - jaħdem biex jiżgura li l-pazjenti fl-UE jkollhom aċċess għal mediċini ta' kwalità għolja, effettivi u siguri.
English: In order to be imported into the EU, an active pharmaceutical ingredient needs to be accompanied by a Written Confirmation issued by the competent authority of the country where it is produced, confirming that the good manufacturing practice (GMP) applied is at least equivalent to the recognised EU GMP standards.
Maltese: Sabiex ikun impurtat fl-UE, ingredjent farmaċewtiku attiv jeħtieġ ikun akkumpanjat b'Konferma bil-Miktub maħruġa mill-awtorità kompetenti tal-pajjiż fejn ikun prodott, li tikkonferma li l-prassi tajba ta' manifattura (PTM) applikata hija minn tal-inqas ekwivalenti għall-istandards rikonoxxuti ta' PTM tal-UE.
English: For the EU, one of the main forums for multilateral international cooperation is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which brings together medicines regulatory authorities and pharmaceutical industry from around the world.
Maltese: Għall-UE, wieħed mill-fora ewlenin għal kooperazzjoni internazzjonali multilaterali huwa l-Kunsill Internazzjonali għall-Armonizzazzjoni tar-Rekwiżiti Tekniċi għall-Prodotti tal-Farmaċewtika għal Użu mill-Bniedem (ICH), li jressaq flimkien l-awtoritajiet regolatorji tal-mediċini u l-industrija tal-farmaċewtika tal-Ewropa, il-Ġappun u l-Istati Uniti.
English: If the product is manufactured outside the EU and has been imported, it needs to undergo full analytical testing in the EU, unless a mutual recognition agreement (MRA) is in place between the EU and the exporting country.
Maltese: Jekk il-prodott ikun manifatturat barra l-UE u ġie importat, jeħtieġ li jgħaddi minn ittestjar analitiku sħiħ fl-UE, diment li ma jkunx fis-seħħ ftehim ta' rikonoxximent reċiproku (MRA) bejn l-UE u l-pajjiż esportatur.
English: Safety monitoring of medicines
Maltese: Monitoraġġ ta' sigurtà tal-mediċini
English: The use of the centrally authorised procedure is compulsory for most innovative medicines, including medicines for rare diseases.
Maltese: L-użu tal-proċedura awtorizzata ċentralment hija obbligatorja għall-biċċa l-kbira tal-mediċini innovattivi, inklużi mediċini għal mard rari.
English: Authorisation and supervision of manufacturers
Maltese: Awtorizzazzjoni u superviżjoni tal-manifatturi
English: The same rules and harmonised procedures apply to all the 28 Member States regarding the authorisation of medicines and the supervision of the safety medicines.
Maltese: L-istess regoli u proċeduri armonizzati japplikaw għall-Istati Membri kollha fir-rigward tal-awtorizzazzjoni ta' mediċini u s-superviżjoni tas-sigurtà tal-mediċini.
English: • the decentralised procedure where companies can apply for the simultaneous authorisation of a medicine in more than one EU Member State if it has not yet been authorised in any EU country and does not fall within the scope of the centralised procedure;
Maltese: • il-proċedura deċentralizzata, fejn il-kumpaniji jistgħu japplikaw għall-awtorizzazzjoni simultanja ta' mediċina f'aktar minn Stat Membru wieħed tal-UE jekk din tkun għadha ma ġietx awtorizzata fl-ebda pajjiż tal-UE u ma taqax fl-ambitu tal-proċedura ċentralizzata;
English: This is an important tool to help develop and make available high-quality, effective and safe medicines, for the benefit of patients.
Maltese: Din hija għodda importanti biex ikunu faċilitati l-iżvilupp u d-disponibbiltà ta' mediċini ta' kwalità għolja, effettivi u siguri, għall-benefiċċju tal-pazjenti.
English: A waiver applies for some countries which have applied to have their regulatory systems for the supervision of manufacturers of active pharmaceutical ingredients assessed by the EU and have been found to be equivalent to the EU.
Maltese: Tapplika deroga għal xi pajjiżi li applikaw biex is-sistemi regolatorji tagħhom għas-superviżjoni tal-manifatturi ta' ingredjenti farmaċewtiċi attivi jkunu vvalutati mill-UE u li nstabu li huma ekwivalenti għall-UE.
English: EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information.
Maltese: L-EMA u l-Istati Membri jikkooperaw u jikkondividu l-ħila esperta fil-valutazzjoni ta' mediċini ġodda u ta' informazzjoni ta' sigurtà ġdida.
English: The authorisation and oversight of a clinical trial is the responsibility of the Member State in which the trial is taking place.
Maltese: L-awtorizzazzjoni u s-superviżjoni ta' prova klinika huma r-responsabbiltà tal-Istat Membru fejn tkun qed isseħħ il-prova.
English: Inspection outcomes can be accessed by all Member States and are made publicly available across the EU through EudraGMDP.
Maltese: L-Istati Membri kollha jistgħu jiksbu aċċess għall-eżiti tal-ispezzjoni li huma pubblikament disponibbli mal-UE kollha permezz tal-EudraGMDP.
English: EMA's scientific committees
Maltese: Kooperazzjoni internazzjonali
English: The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.
Maltese: L-awtoritajiet regolatorji ta' kull Stat Membru huma responsabbli biex jagħtu l-liċenzji għal attivitajiet bħal dawn li jseħħu fi ħdan it-territorji rispettivi tagħhom.
English: primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU.
Maltese: teknoloġija żviluppati minn kumpaniji tal-farmaċewtika għall-użu fl-UE.
English: A subset of this information is made publicly available by EMA via the EU clinical trials register.
Maltese: L-EMA tqiegħed għad-dispożizzjoni tal-pubbliku subsett ta' din l-informazzjoni permezz tar-reġistru ta' provi kliniċi tal-UE.
English: EMA/307224/2015 EMEA/H/C/000982
Maltese: EMEA/H/C/000982
English: The full EPAR for Celvapan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Celvapan jinstab fis-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: One study involved 408 healthy adults, half of whom were over 60 years of age (202 received a full dose of Celvapan, the others a half dose) and the second involved 167 healthy children aged between six months and 17 years (101 received a full dose of Celvapan, the others a half dose).
Maltese: Studju minnhom involva 408 adulti f'saħħithom, b'nofshom ikollhom iktar minn 60 sena (202 ngħataw doża sħiħa ta' Celvapan, u l-oħrajn nofs doża) filwaqt li t-tieni studju involva 167 tifel u tifla f'saħħithom ta' bejn is-sitt xhur u s-17-il sena (101 ngħataw doża sħiħa ta' Celvapan, l
English: This is a summary of the European Public Assessment Report (EPAR) for Celvapan.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Celvapan.
English: Celvapan contains a flu strain called A/California/07/2009 (H1N1)v.
Maltese: Celvapan fih razza ta' influwenza msejħa A/California/07/2009 (H1N1)v.
English: Celvapan is a vaccine.
Maltese: Celvapan huwa vaċċin.
English: influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Maltese: vaċċin tal-influwenza (H1N1)v (virjon sħiħ, derivat minn ċelloli Vero,