FrancophonIA/ELRC3.0 huggingface dataset:
English: Improve the transparency of EMEA activities; provide access to EudraVigilance data, information on clinical trials, data held in EudraGMP and EMEA documents in general, in line with agreed access policies.
Maltese: Ittejjeb it-trasparenza ta' l-attivitajiet ta' l-EMEA; tipprovdi aċċess għad-data ta' l-EudraVigilance, informazzjoni dwar provi kliniċi, data miżmuma fil-EudraGMP u d-dokumenti in ġenerali ta' lEMEA, b'mod konformi ma' politika miftiehma ta' aċċess;
English: Direct telephone: (44-20) 74 18 85 81 E-mail: vet-phv@emea.europa.eu
Maltese: (44-20) 75 23 70 40 E-mail: smeoffice@emea.europa.eu
English: Infrastructure services
Maltese: Serivzzi ta' infrastruttura
English: In 2008, the scope of the mandatory centralised procedure will extend to products for autoimmune diseases and other immune dysfunctions and viral diseases.
Maltese: Fl-2008, l-ambitu tal-proċedura ċentralizzata obbligatorja sejra tiġi estiża għallprodotti għall-mard awtoimmuni u għal disfunzjonijiet oħra tas-sistema immunitarja u għal mard virali.
English: Applications (Input)
Maltese: Applications for designation (input)
English: In the field of information provision, the Agency will consolidate related activities into the EMEA programme on provision of information.
Maltese: Fil-qasam tal-forniment ta' informazzjoni, l-Aġenzija se tikkonsolida attivitajiet relatati fil-programm ta' l-EMEA dwar il-forniment ta' informazzjoni.
English: The Community database of manufacturing authorisations and GMP certificates, EudraGMP, will be expanded to contain a module with negative inspection outcomes (EU telematics project).
Maltese: Id-database Komunitarju ta' l-awtorizzazzjonijiet għall-manifattura u għaċ-ċertifikati tal-GMP, EudraGMP, sejra tiġi mkabbra sabiex ikun fiha modulu bir-riżultati negattivi ta' l-ispezzjonijiet (proġett tat-telematika ta' l-UE).
English: Meanwhile, requests for other types of information are forecast to increase by a further 29%, to some 4,500 requests.
Maltese: Sadanittant, talbiet għal tipi oħrajn ta' informazzjoni huwa mbassar li jiżdiedu b'29% oħra għal xi 4,500 talba.
English: Establishment of maximum residue limits for veterinary medicines
Maltese: Ifissar ta' limiti massimi ta' residwi għall-mediċini għal użu veterinarju
English: NATIONAL COMPETENT AUTHORITIES 4,000 EUROPEAN EXPERTS
Maltese: KOMPENTENTI 4,000
English: In 2008, the Agency will continue its work to tackle major public- and animal-health threats, including the development of antimicrobial resistance, pandemic influenza, avian influenza and other epizootic diseases such as bluetongue.
Maltese: Fl-2008, l-Aġenzija se tkompli xogħolha biex tindirizza theddidiet kbar għas-saħħa pubblika u għallannimali, inkluż l-iżvilupp ta' reżistenza antimikrobika, influwenza pandemika u mard epiżotiku ieħor bħal Bluetongue.
English: Ragini SHIVJI
Maltese: Applikazzjonijiet ġeneriċi
English: GCP and pharmacovigilance inspections are expected to rise relative to previous years, taking into account the GCP policy on increasing numbers of routine inspections and increasing pharmacovigilance activity, as well as the need for greater supervision of the conduct and ethical standards of clinical trials performed outside the EU.
Maltese: L-ispezzjonijiet GCP u dawk ta' farmakoviġilanza huma mistennija li jiżdiedu meta mqabbla mas-snin preċedenti, filwaqt li titqies il-politika tal-GCP dwar in-numru dejjem jikber ta' l-ispezzjonijiet ta' rutina u ż-żieda fl-attività ta' farmakoviġilanza, kif ukoll il-ħtieġa għal superviżjoni akbar tal-kondotta u ta' l-istandards etiċi tal-provi kliniċi mwettqa barra l-UE.
English: Scientific advice and orphan drugs
Maltese: Konsulenza xjentifika u mediċini orfni
English: General EU contribution EU contribution for SME policy EU contribution for paediatrics policy EU contribution for IT Telematics strategy Special EU contribution for orphan medicinal products
Maltese: Kontribut Ġenerali ta' l-UE Kontribut ta' l-UE għall-politika SME Kontribut ta' l-UE għall-politika pedjatrika Kontribut ta' l-UE għall-istrateġija tat-telematika ta' l-IT
English: Requested for
Maltese: Settur legali
English: Another type of advice relates to the assessment of dossier requirements in relation to products for limited markets.
Maltese: Tip ieħor ta' konsulenza għandu x'jaqsam mal-valutazzjoni tar-rekwiżiti ta' dossier fir-rigward tal-prodotti għal swieq limitati.
English: The Agency's work with its international partners will intensify, particularly in the context of the continued implementation of confidentiality arrangements with the US Food and Drug Administration (FDA), and implementation of the recently signed arrangements with the Japanese and Canadian health authorities.
Maltese: Xogħol l-Aġenzija ma' l-imsieħba internazzjonali se jintensifika, b'mod partikolari fil-kuntest ta' implimentazzjoni kontinwa ta' arranġamenti kunfidenzjali ma' l-US Food and Drug Administration (FDA) u l-implimentazzjoni ta' arranġamenti li ġew iffirmati dan l-aħħar ma' awtoritajiet tas-saħħa Ġappuniżi u Kanadiżi.
English: Following receipt of the first applications for paediatric investigation plans (PIPs) and waivers during 2007 - the first year of implementation of the regulation on paediatric medicines - the number of applications is expected to be maintained during 2008, with around 400 clinical indications in new PIP and paediatric-waiver applications.
Maltese: Wara li waslu l-ewwel applikazzjonijiet għall-pjanijiet ta' investigazzjoni pedjatriċi (paediatric investigation plans - PIPs) u d-derogi matul l-2007 - l-ewwel sena ta' l-implimentazzjoni tarregolament dwar il-mediċini pedjatriċi - in-numru ta' applikazzjonijiet huwa mistenni li jinżamm matul l-2008, b'madwar 400 indikazzjoni klinika fl-applikazzjoni ta' PIP ġodda u applikazzjonijiet għal deroga pedjatrika.
English: These agreements are in operation with Australia, New Zealand, Switzerland, Canada and Japan, and allow the conclusions of inspections of manufacturers carried out by respective inspection services to be mutually recognised.
Maltese: Dawn il-ftehimiet huma fis-seħħ ma' l-Awstralja, in-New Zealand, l-Iżvizzera, il-Kanada u l-Ġappun u jippermettu li jkun hemm rikonoxximent reċiproku tal-konklużjonijiet ta' l-ispezzjonijiet tal-produtturi mwettqa mis-servizzi rispettivi ta' spezzjoni.
English: Additional functionalities will be added to the database and known defects resolved in the course of 2008 (EU telematics project).
Maltese: Matul l2008, sejrin jiżdiedu fid-database funzjonalitajiet addizzjonali u sejrin jiġu solvuti diffetti magħrufa (il-proġett tat-telematika ta' l-UE).
English: Over 4,000 experts are used by the EMEA in its scientific evaluation work.
Maltese: Fix-xogħol tal-valutazzjoni xjentifika, l-EMEA tuża aktar minn 4,000 espert.
English: Herbal medicinal products
Maltese: Prodotti mediċinali speċifiċi
English: The Agency is responsible for operational aspects of mutual-recognition agreements (MRA) between the European Community and partner (third) countries.
Maltese: L-Aġenzija hija responsabbli għall-aspetti operattivi tal-ftehim għar-rikonoxximent reċiproku (mutualrecognition agreements - MRA) bejn il-Komunità Ewropea u l-pajjiżi imsieħba (pajjiżi terzi).
English: POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
Maltese: Kap: Noël Wathion
English: This will include building on its successful collaboration with the US Food and Drug Administration (FDA) as a model for co-operation with the Japanese and Canadian authorities.
Maltese: Dan jinkludi li tibni fuq il-kollaborazzjoni ta' suċċess ma' l-US Food and Drug Administration (FDA) bħala mudell ta' kooperazzjoni ma' awtoritajiet Ġappuniżi u Kanadiżi.
English: EUROPEAN UNION INSTITUTIONS
Maltese: Programmi Komunitarji
English: The authorities will also be involved in the EU telematics programme.
Maltese: L-awtoritajiet se jkunu wkoll involuti fil-programm tattelematika ta' l-UE.
English: This approach will assist with the provision of reliable and robust IT services to staff, delegates and all users of pan-European systems.
Maltese: Dan l-approċċ se jgħin bl-għoti ta' servizzi ta' l-IT affidabbli u b'saħħithom lill-personal, delegati u dawk kollha li jużaw sistemi pan-Ewropej.
English: The EMEA will also work in the field of environmental risk assessment and will provide support to programmes aimed at reducing animal testing.
Maltese: L-EMEA se taħdem ukoll fil-qasam tal-valutazzjoni tar-riskji ambjentali u se tipprovdi appoġġ lil programmi mmirati li jnaqqsu t-testijiet fuq l-annimali.
English: This includes the publication of agendas and minutes of meetings of the Management Board, as well as of information from various EMEA committees on non-product-related issues; and providing access to the EudraVigilance database and to information on paediatric clinical trials (EU telematics project), in line with agreed access policies.
Maltese: Dan jinkludi l-pubblikazzjoni ta' aġendi u minuti ta' laqgħat tal-Bord Maniġerjali, kif ukoll ta' informazzjoni minn numru ta' kumitati ta' l-EMEA dwar kwistjonijiet mhux relatati mal-prodotti; u tipprovdi aċċess għad-database ta' lEudraVigilance u għal informazzjoni dwar provi kliniċi pedjatriċi (proġett tat-telematika ta' l-UE), b'mod konformi ma' politika ta' aċċess li jkun sar qbil fuqhom.
English: Doc.
Maltese: Personal
English: Annex 4 EMEA contact points Pharmacovigilance and product-quality-defect reporting
Maltese: Farmakoviġilanza u rappurtar ta' prodotti ta' kwalità difettuża
English: COMP Committee for Orphan Medicinal Products
Maltese: Deżinjazzjoni ta' prodotti mediċinali orfni
English: E-mail: certificate@emea.europa.eu authorised medicines for human or veterinary use
Maltese: E-mail: certificate@emea.europa.eu Linja telefonika diretta:
English: Work is progressing in this area and additional proposals on how to tackle this issue will be considered in the revised Road Map which the EMEA will develop to steer the Agency's course from 2010 to 2013.
Maltese: Ix-xogħol f'dan il-qasam għadu għaddej u proposti addizzjonali dwar kif għandha tiġi indirizzata din il-kwistjoni se jkunu kkunsidrati fir-Road Map rivedut li l-EMEA se tiżviluppa biex tiggwida x-xogħol ta' l-Aġenzija mill-2010 sa l-2013.
English: As part of this initiative, the EMEA will finalise the development of its communication strategy and will consolidate the various communication tools into a communication ‘platform'.
Maltese: Bħala parti minn din l-inizjattiva, l-EMEA sejra tiffinalizza l-iżvilupp ta' l-istrateġija tagħha ta' komunikazzjoni u sejra ssaħħaħ diversi strumenti ta' komunikazzjoni fi pjattaforma ta' komunikazzjoni.
English: Continue the contribution to pan-European efforts to facilitate innovation and research, and thus to increase availability of medicines, in particular through participation in the work of the Innovative Medicines Initiative for human medicines, the European Technology Platform for Global Animal Health for veterinary medicines, and the continued implementation of recommendations of the EMEA/CHMP Think-Tank Group on innovative drug development.
Maltese: Tippromwovi s-superviżjoni ta' mediċini veterinarji ladarba jiġu awtorizzati, permezz ta' farmakoviġilanza effikaċi u mmirata, li tinkludi iżjed żvilupp u użu ta' database veterinarja ta' lEudraVigilance għal sorveljanza kontinwa, u twaqqif tal-kunċett ta' pjanijiet dwar ġestjoni tarriskji kif tapplika għall-kuntest veterinarju.
English: The variety of scientific-advice requests will also increase, from advice on products subject to the centralised procedure, to alternative clinical-trial design, to programmes for products intended for non-EU markets.
Maltese: Il-varjetà ta' talbiet għal konsulenza xjentifika sejra tiżdied ukoll, minn konsulenza fuq prodotti soġġetti għall-proċedura ċentralizzata, għad-disinjar ta' provi kliniċi alternattivi, għall-programmi għall-prodotti maħsuba għas-swieq li mhumiex fl-UE.
English: The EMEA receives safety reports and product-quality-defect reports from within the EU and outside concerning centrally authorised medicinal products, and coordinates action relating to the safety and quality of medicinal products.
Maltese: L-EMEA tirċievi rapporti dwar is-sigurtà u rapporti dwar il-prodotti ta' kwalità difettuża mill-UE u minn pajjiżi terzi dwar il-prodotti mediċinali awtorizzati bi proċedura ċentralizzata u tikkoordina l-azzjoni dwar issigurtà u l-kwalità tal-prodotti mediċinali.
English: The Agency will continue supporting the coordination groups for mutual-recognition and decentralised procedures (human and veterinary products).
Maltese: L-Aġenzija se tkompli tappoġġa l-gruppi ta' koordinament għar-rikonoxximent reċiproku u proċeduri deċentralizzati (prodotti għall-użu tal-bniedemu u veterinarji).
English: CHMP Committee for Medicinal Products for Human Use
Maltese: Applikazzjonijiet għal prodotti mediċinali ġodda
English: The Agency's Committee on Herbal Medicinal Products (HMPC) provides scientific opinions on questions relating to herbal medicines; establishes Community herbal monographs for traditional and well-established herbal medicinal products; establishes a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products; provides opinions on herbal substances as needed; and evaluates referrals and arbitrations concerning traditional herbal medicinal products.
Maltese: Il-Kumitat ta' l-Aġenzija dwar il-Prodotti Mediċinali Magħmulin mill-ħxejjex (Committee on Herbal Medicinal Products - HMPC) jipprovdi opinjonijiet xjentifiċi fuq mistoqsijiet relatati mal-mediċini magħmulin mill-ħxejjex; jistabbilixxi monografiji magħmulin mill-ħxejjex għall-Komunità għal prodotti mediċinali magħmulin mill-ħxejjex tradizzjonali stabbiliti sew, jistabbilixxi abbozz ta' lista ta' sustanzi magħmulin mill-ħxejjex, preparazzjonijiet u taħlit tagħhom għall-użu fil-prodotti mediċinali magħmulin mill-ħxejjex tradizzjonali; jipprovdi opinjonijiet fuq is-sustanzi magħmulin mill-ħxejjex kif ikun neċessarju, u jevalwa rakkomandazzjonijiet u arbitraġġi dwar prodotti mediċinali magħmulin mill-ħxejjex tradizzjonali.
English: GMP inspection numbers will continue their steep growth, with a further 30% increase expected compared to 2007.
Maltese: In-numru ta' l-ispezzjonijiet ta' GMP sejjer ikompli jiżdied, b'mod rapidu u huwa mistenni li jkun hemm żieda oħra ta' 30% meta mqabbel ma' l-2007.
English: Continue implementation of the EMEA Road Map and contribute to the implementation of the Heads of Medicines Agencies strategy paper; commence preparation of the EMEA Road Map
Maltese: Tkompli timplimenta r-Road Map ta' l-EMEA u tikkontribwixxi għall-implimentazzjoni taddokument strateġiku tal-Kapijiet ta' l-Aġenziji tal-Mediċini; tibda l-preparattivi tar-Road Map ta' lEMEA 2010-2013.
English: Revenue
Maltese: Spezzjonijiet
English: The EMEA will work with the Heads of Veterinary Medicines Agencies to implement initiatives to be adopted by the EMEA Management Board aimed at facilitating greater availability of veterinary medicines through a set of measures to assist companies seeking to authorise products for minor species and/or limited markets.
Maltese: L-EMEA se taħdem mal-Kapijiet ta' l-Aġenziji ta' Mediċini Veterinarji biex timplimenta inizjattivi li jkunu adottati mill-Bord Maniġerjali ta' l-EMEA, intenzjonat sabiex jiffaċilita disponibbiltà akbar ta' mediċini veterinarji permezz ta' sett ta' miżuri biex jgħinu kumpaniji li jkunu qed jitolbu lawtorizzazzjoni ta' prodotti għal speċi minuri u/jew swieq limitati.
English: In addition, the Agency plans to upgrade the functionality of the EudraCT database as specified by the Clinical Trials Facilitation Group (EU telematics project).
Maltese: Ma' dan, l-Aġenzija qiegħda tippjana li taġġorna l-funzjonalità tad-database ta' l-EudraCT kif speċifikat mill-Grupp ta' Faċilità tal-Provi Kliniċi (proġett tat-telematika ta' l-UE).
English: Develop and implement the EMEA communications strategy and information-related aspects of the EMEA Road Map in order to adapt the current EMEA information practices and improve the provision of information to all stakeholders.
Maltese: Tiżviluppa u timplimenta l-istrateġija tal-komunikazzjoni ta' l-EMEA u aspetti relatati ma' informazzjoni tar-Road Map ta' l-EMEA sabiex tadotta l-prattiċi attwali ta' l-informazzjoni ta' lEMEA u ttejjeb l-forniment ta' informazzjoni għall-partijiet interessati kollha;
English: Occupied as per
Maltese: Sostenn ta' l-eżekuttiv
English: The focus of additional activities in the area of evaluation of veterinary medicines will include further improvement of the quality-assurance system in respect of the procedures of the Committee for Medicinal Products for Veterinary Use (CVMP) and establishing systems for peer review of the quality and consistency of scientific assessments.
Maltese: L-attenzjoni ta' l-attivitajiet addizzjonali fil-qasam ta' l-valutazzjoni tal-mediċini veterinarji sejra tinkludi aktar titjib tas-sistema ta' assigurazzjoni tal-kwalità fil-każ tal-proċeduri tal-Kumitat għallProdotti Mediċinali għal Użu Veterinajru (Committee for Medicinal Products for Veterinary UseCVMP) u t-twaqqif ta' sistemi għar-reviżjoni fost il-pari tal-kwalità u tal-koerenza tal-valutazzjonijiet xjentifiċi.
English: Scientific advice and protocol assistance
Maltese: Scientific advice and follow-up requests
English: Sabine BROSCH
Maltese: ESPERT EWROPEW
English: As part of this initiative, the Agency will launch a revised survey with IFAH-Europe of its procedures for authorisation of veterinary medicinal products.
Maltese: Il-Bord Maniġerjali ta' l-Aġenzija introduċa sett ta' miżuri sabiex jappoġġa d-disponibbiltà ta' prodotti mediċinali għal użu veterinarju.
English: CVMP Committee for Medicinal Products for Veterinary Use
Maltese: CVMP Kumitat għallProdotti Mediċinali għall-Użu Veterinarju
English: SME Office
Maltese: Ħruġ
English: In the area of information technology, the Agency will progress the deployment of best-practice-support processes based on the IT Infrastructure Library (ITIL) service management.
Maltese: Fil-qasam tat-teknoloġiji ta' l-informazzjoni, l-Aġenzija se tagħmel progess fl-użu tal-proċessi ta' appoġġ għall-aħjar prattika bbażata fuq il-ġestjoni tas-servizz tal-Librerija ta' l-Infrastruttura ta' l-IT (ITIL).
English: Based on the initial experience during 2007, there is a clear trend for an increase in referral procedures in the context of the suspension or revocation of marketing authorisations as a result of the evaluation of pharmacovigilance data.
Maltese: Skond l-esperjenza inizjali matul l-2007, hemm tendenza ċara ta' żieda fil-proċeduri ta' riferenzi filkuntest tas-sospensjoni jew tar-revoka ta' l-awtorizzazzjonijiet għat-tqegħid fis-suq bħala riżultat ta' lvalutazzjoni tad-data tal-farmakoviġilanza.
English: For enquiries concerning VAMF certificates
Maltese: Ċertifikati ta' prodott mediċinali
English: Sampling from the market in different countries is carried out by national inspectorates and testing is performed by official medicines-control laboratories coordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM).
Maltese: It-teħid tal-kampjuni mis-suq f'pajjiżi differenti jitwettaq mill-ispettorati nazzjonali u l-ittestjar isir mil-laboratorji uffiċjali għall-kontroll tal-mediċini kkoordinati mid-Direttorat Ewropew għall-Kwalità tal-Mediċini u għall-Kura tas-Saħħa (European Directorate for the Quality of Medicines and HealthCare - EDQM).
English: The Agency's integrated quality policy has been in operation for ten years, and its robust, integrated quality-management system is subject to continuous improvement.
Maltese: Verifika u Ġestjoni integrata ta' kwalità
English: Continue to apply a proactive approach to safety of medicines throughout their lifecycle, through initiatives undertaken in the context of the European Risk-Management Strategy (ERMS), in particular by implementing the ENCePP (European Network of Centres of Pharmacovigilance and Pharmacoepidemiology) project, by further developing EudraVigilance as a cornerstone of the EU Pharmacovigilance System, and by further improving the concept of risk-management plans for medicines for human use.
Maltese: Tkompli tapplika approċċ proattiv għas-sigurtà ta' mediċini matul iċ-ċiklu tal-ħajja tagħhom permezz ta' inizjattivi mwettqa fil-kuntest ta' Strateġija Ewropea ta' Ġestjoni tar-Riskji (ERMS), b'mod partikolari billi timplimenta l-proġett ENCePP (Network Ewropew ta' Ċentri ta' Farmakoviġilanza u Farmakoepidemjoloġija), billi tiżviluppa iżjed l-EudraVigilance bħala pilastru tas-Sistema ta' Farmakoviġilanza ta' l-UE, u billi ttejjeb iżjed il-kunċett ta' pjanijiet dwar ġestjoni tar-riskji ta' mediċini għall-użu tal-bniedem;
English: INTRODUCTION BY THE EXECUTIVE DIRECTOR
Maltese: Introduzzjoni mid-Direttur Eżekuttiv
English: 4 Appropriation/Draft Budget 2008 as adopted by the Management Board on 13 December 2007.
Maltese: Approprjazzjoni/Abbozz tal-Baġit 2008 kif adottat mill-Bord Maniġerjali fit-13 ta' Diċembru 2007
English: The number of arbitrations and referrals remains difficult to predict, but the increasing trend since the introduction of the new legislation is expected to continue.
Maltese: Jibqa' diffiċli li wieħed jipprevedi n-numru ta' arbitraġġi u ta' riferenzi iżda ż-żieda fit-tendenza millintroduzzjoni tal-leġiżlazzjoni l-ġdida hija mistennija tkompli.
English: The Agency will advance projects such as EU Telematics Controlled Terms and Product Information Management (PIM), together with a number of other systems mentioned in the relevant sections of this work programme.
Maltese: L-Aġenzija se tipproponi proġetti bħal Termini Kontrollati tat-Telematika ta' l-UE, Ġestjoni ta' l-Informazzjoni talProdott (PIM) flimkien ma' numru ta' sistemi oħrajn imsemmija fis-sezzjonijiet relevanti ta' dan ilprogramm ta' ħidma.
English: Currently available data are described in section 4.3, 4.4, 4.8, 5.1 and 5.2.
Maltese: Data disponibbli fil-preżent hija deskritta fis-sezzjonijiet 4.3, 4.4, 4.8, 5.1 u 5
English: Children and adolescents up to 18 years of age (see sections 4.4 and 4.8).
Maltese: Tfal u adoloxxenti li għandhom sa 18-il sena (ara sezzjonijiet 4.4 u 4.8).
English: Cardioxane is contraindicated in children and adolescents up aged 0 to 18 years of age who are planned to receive a cumulative dose of less than 300 mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline.
Maltese: Cardioxane huwa kontraindikat fi tfal u adoloxxenti li għandhom sa ta' bejn iż-0 u t-18-il sena li huma maħsuba li se jirċievu doża kumulattiva ta' inqas minn 300 mg/m² ta' doxurubicin jew id-doża kumulattiva ekwivalenti ta' anthracycline oħra.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tkun sussegwentement aġġornata mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti filKapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: Annex III Amendments to the relevant sections of the Product information
Maltese: Anness III Emendi għas-sezzjonijiet relevanti tal-Informazzjoni dwar il-Prodott
English: Cardioxane is contraindicated in children aged 0 to 18 years who are planned to receive a cumulative dose of less than 300 mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline (see sections 4.4 and 4.8).
Maltese: Cardioxane huwa kontraindikat fi tfal ta' bejn iż-0 u t-18-il sena li huma maħsuba li se jirċievu doża kumulattiva ta' inqas minn 300 mg/m² ta' doxurubicin jew id-doża kumulattiva ekwivalenti ta' anthracycline oħra (ara sezzjonijiet 4.4 u 4.8). Cardioxane huwa kontraindikat ukoll fiċ-ċirkostanzi segwenti: