FrancophonIA/ELRC3.0 huggingface dataset:
English: • anticoagulants, used to prevent and treat blood clots, such as: apixaban, edoxaban, rivaroxaban and warfarin
Maltese: • mediċini kontra t-tagħqid tad-demm, li jintużaw għall-prevenzjoni u t-trattament ta' emboli tad-demm, bħal: apixaban, edoxaban, rivaroxaban u warfarin
English: Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Maltese: Il-konċentrazzjonijiet ta' imblokkaturi tal-kanal tal-calcium jistgħu jiżdiedu meta jingħataw flimkien ma' cobicistat.
English: GLUCOCORTICOIDS
Maltese: Metoprolol Timolol
English: Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product.
Maltese: L-għoti flimkien ta' emtricitabine ma' prodotti mediċinali li jiġu eliminati permezz ta' tnixxija tubulari attiva, jista' jżid il-konċentrazzjonijiet ta' emtricitabine, u/jew tal-prodott mediċinali mogħti flimkien.
English: When administering with Genvoya, the maximum daily dose of itraconazole should not exceed 200 mg per day.
Maltese: Meta jingħata ma' Genvoya, id-doża massima ta' kuljum ta' itraconazole m'għandhiex taqbeż 200 mg kuljum.
English: Cockcroft-Gault method, and urine protein to creatinine ratio and after 96 weeks treatment by urine albumin to creatinine ratio) compared to E/C/F/TDF (see also section 4.4).
Maltese: Fi studji f'pazjenti li qatt ma ngħataw trattament fil-passat, Genvoya ġie assoċjat ma' impatt iżgħar fuq parametri tas-sigurtà renali (kif imkejla wara 144 ġimgħa ta' trattament mir-rata tal-filtrazzjoni glomerulari stmata bil-metodu Cockcroft-Gault, u l-proporzjon ta' proteina fl-awrina mal-kreatinina u wara 96 ġimgħa ta' trattament mill-proporzjon ta' albumina fl-awrina mal-kreatinina) meta mqabbel ma' E/C/F/TDF (ara wkoll sezzjoni 4.4).
English: Clinical monitoring is recommended upon co-administration of Genvoya.
Maltese: Monitoraġġ kliniku hu rakkomandat meta jingħata flimkien ma' Genvoya.
English: Co-administration of Genvoya and orally administered midazolam is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Genvoya u midazolam li jingħata mill-ħalq hu kontraindikat (ara sezzjoni 4.3).
English: No clinically relevant differences in elvitegravir, cobicistat, or tenofovir alafenamide pharmacokinetics were observed in patients with end stage renal disease on chronic haemodialysis as compared to those with normal renal function.
Maltese: Ma kinux osservati differenzi klinikament rilevanti fil-farmakokinetika ta' elvitegravir, cobicistat, jew tenofovir alafenamide f'pazjenti b'marda tal-kliewi fl-aħħar stadju fuq emodijalisi kronika meta mqabbla ma' dawk b'funzjoni renali normali.
English: Genvoya may interact with other medicines.
Maltese: Genvoya jista' jinteraġixxi ma' mediċini oħrajn.
English: Patients should be informed that dizziness has been reported during treatment with Genvoya.
Maltese: Il-pazjenti għandhom jiġu infurmati li l-isturdament kien irrappurtat waqt it-trattament b'Genvoya.
English: Table 5: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Maltese: Il-farmakokinetika ta' elvitegravir, cobicistat, emtricitabine, tenofovir, u tenofovir alafenamide f'adolexxenti u adulti li qatt ma ngħataw antiretrovirali fil-passat
English: Disproportionality analysis did not highlight events that met the criteria for signal of disproportionate reporting.
Maltese: Analiżi ta' sproporzjonalità ma enfasizzatx avvenimenti li ssodisfaw il-kriterji għal sinjal ta' rappurtar sproporzjonat.
English: 25 July 2014 EMEA/H/C/002418
Maltese: EMEA/H/C/002418
English: Withdrawal of the marketing authorisation application for Neofordex (dexamethasone) EMA/443387/2014
Maltese: (dexamethasone) EMA/443387/2014
English: What is Neofordex?
Maltese: X'inhu Neofordex?
English: Neofordex was developed as a ‘hybrid medicine'.
Maltese: Neofordex kien żviluppat bħala ‘mediċina ibrida'.
English: Neofordex is a corticosteroid medicine that contains the active substance dexamethasone.
Maltese: Nefordex huwa mediċina kortikosterojde li fiha s-sustanza attiva dexamethasone.
English: It was to be available as 40 mg tablets.
Maltese: Dan kellu jkun disponibbli bħala pilloli ta' 40 mg.
English: While the reference medicine Dectancyl is available as 0.5 mg tablets, Neofordex was to be available as 40 mg tablets.
Maltese: Waqt li l-mediċina ta' referenza Dectancyl hija disponibbli bħala pilloli ta' 0.5 mg, Neofordex kien se jkun disponibbli bħala pilloli ta' 40 mg.
English: This means that it was intended to be similar to a ‘reference medicine' containing the same active substance, but in a higher strength.
Maltese: Dan ifisser li kien intenzjonat li jkun simili għal ‘mediċina ta' referenza' li jkun fiha l-istess sustanza attiva, imma iktar qawwija.
English: Withdrawal of the marketing authorisation application for Neofordex (dexamethasone)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Neofordex (dexamethasone)
English: The active substance in Neofordex and Dectancyl, dexamethasone, belongs to a group of medicines known as corticosteroids, which reduce the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cells.
Maltese: Is-sustanza attiva f'Neofordex u Dectancyl, id-dexamethasone, tappartjeni lil grupp ta' mediċini magħrufa bħala kortikosterojdi, li jnaqqsu l-attività tas-sistema immunitarja (id-difiżi naturali talġisem) billi jaqbdu ma' riċetturi f'diversi tipi ta' ċelloli immuni.
English: Neofordex was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 6 June 2010 for the treatment of multiple myeloma.
Maltese: Neofordex kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-6 ta' Ġunju għallkura tal-majeloma multipla.
English: In multiple myeloma, high-dose
Maltese: Mistoqsijiet u tweġibiet
English: Because Neofordex was assessed as a hybrid medicine, and the effects of high-dose dexamethasone in multiple myeloma are well established, the company presented the results of a study carried out to investigate whether it is bioequivalent to the reference medicine, Dectancyl.
Maltese: Billi Neofordex kien ivvalutat bħala mediċina ibrida, u l-effetti tad-dexamethasone f'dożi qawwija filmajeloma multipla huma stabbiliti sewwa, il-kumpanija ppreżentat ir-riżultati ta' studju li twettaq sabiex jinvestiga jekk huwiex bijoekwivalenti għall-mediċini ta' referenza, Dectancyl.
English: How is Neofordex expected to work?
Maltese: Għal xiex kien mistenni li jintuża Neofordex?
English: On 17 July 2014, Laboratories CTRS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Neofordex, for the treatment of multiple myeloma.
Maltese: Fis-17 ta' Lulju 2014, Laboratories CTRS għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għall-awtorizzazzjoni għattqegħid fis-suq għal Neofordex, għall-kura tal-majeloma multipla.
English: Multiple myeloma is a cancer of the plasma cells in the bone marrow.
Maltese: Il-majeloma multipla hija kanċer taċ-ċelloli tal-plażma fil-mudullun.
English: dexamethasone is used together with chemotherapy to make chemotherapy more effective and to reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
Maltese: Aġenzija tal-Unjoni Ewropea effettiva u tnaqqas ċerti effetti sekondarji tal-kura tal-kanċer, bħalma huma n-nawżea (dardir) u rremettar.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Neofordex could not have been approved for the treatment of multiple myeloma.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Neofordex ma setax jiġi approvat għall-kura tal-majeloma multipla.
English: The company also presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Maltese: Il-kumpanija ppreżentat ukoll studji mil-letteratura dwar l-użu tad-dexamethasone għall-kura tal-majeloma multipla.
English: Neofordex was to be used in combination with other medicines to treat adult patients with multiple myeloma who have developed symptoms.
Maltese: Neofordex kellu jintuża flimkien ma' mediċini oħrajn sabiex jiġu kkurati pazjenti adulti b'majeloma multipla li jkunu żviluppaw sintomi.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Neofordex.
Maltese: Il-kumpanija informat lis-CHMP li ma hemm l-ebda konsegwenza għall-pazjenti li bħalissa huma inklużi fi provi kliniċi jew fi programmi ta' użu b'kompassjoni li jużaw in-Neofordex.
English: Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Neofordex did not outweigh its risks.
Maltese: Barra minn hekk, bl-għoti ta' doża qawwija f'pillola waħda, Neofordex kien mistenni li jissimplifika d-dożaġġ.
English: Conditions for lifting the suspension of the marketing authorisations for methadone oral solutions containing povidone
Maltese: Kundizzjoni għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq għal soluzzjonijiet orali ta' methadone li fihom povidon
English: For the suspension to be lifted, National competent authorities of Member States or reference Member States, if applicable, shall ensure that the following condition is fulfilled by the MAHs:
Maltese: Biex is-sospensjoni titneħħa, l-Awtoritajiet nazzjonali kompetenti tal-Istati Membri jew tal-Istati Membri ta' referenza, jekk applikabbli, għandhom jiżguraw li l-kondizzjoni li ġejja tkun sodisfatta millMAHs:
English: Annex IV Condition for lifting the suspension of the marketing authorisations
Maltese: Anness IV
English: The MAHs should appropriately reformulate the product taking into account its misuse potential.
Maltese: Il-MAHs għandhom jirriformulaw kif xieraq il-prodott filwaqt li jqisu l-potenzjal għall-użu ħażin tiegħu.
English: 13 April 2016 EMA/363479/2015
Maltese: EMA/389926/2016
English: Interventions
Maltese: 4.3. Interventi
English: • Therapeutic effect of the medicine/class of medicines and availability of therapeutic alternatives.
Maltese: • L-effett terapewtiku tal-prodott mediċinali/klassi ta' mediċini u d-disponibilità ta' alternattivi terapewtiċi.
English: • Contact information (postal address, e-mail address, telephone number).
Maltese: • Informazzjoni dwar il-kuntatt (indirizz tal-posta, indirizz tal-email, numru tat-telefown).
English: Public hearings at the PRAC - a definition
Maltese: Seduti ta' smigħ pubbliku fil-PRAC - definizzjoni
English: • Information about live-broadcast/web stream.
Maltese: • Informazzjoni dwar xandira diretta/web stream.
English: • Name of the individual.
Maltese: • Isem l-individwu.
English: Chair
Maltese: President
English: Impact on PRAC opinion
Maltese: Impatt fuq l-opinjoni tal-PRAC
English: • Level of public interest.
Maltese: • Livell ta' interess pubbliku.
English: 1.4. Who can attend a public hearing
Maltese: 1.3. Għan ta' seduta ta' smigħ pubbliku
English: The legal basis for holding public hearings in the defined procedures is Article 107j of Directive 2001/83/EC:
Maltese: Il-bażi legali għall-organizzazzjoni ta' seduti ta' smigħ pubbliku fil-proċeduri definiti hija l-Artikolu 107j tad-Direttiva 2001/83/KE.
English: The PRAC has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, Article 31 or Article 107i of Directive 2001/83/EC.
Maltese: Il-PRAC għandu l-possibbiltà li jorganizza seduti ta' smigħ pubbliċi fil-kuntest tal-proċeduri tarriferiment ta' sigurtà skont l-Artikolu 20 tar-Regolament (KE) 726/2004, l-Artikolu 31 jew lArtikolu 107i tad-Direttiva 2001/83/KE.
English: The Agency aims to allocate 10 minutes per person.
Maltese: L-Aġenzija għandha fil-mira li talloka 10 minuti għal kull persuna.
English: Concluding the hearing
Maltese: Konklużjoni tas-seduta ta' smigħ
English: Legal basis
Maltese: 1.1. Bażi legali
English: • Where relevant, request for the provision of translation in case of attendance as a speaker, including information on which official EU language should be translated into English.
Maltese: • Fejn rilevanti, it-talba għad-dispożizzjoni ta' traduzzjoni f'każ ta' attendenza bħala kelliem, inkluż informazzjoni dwar liema lingwa uffiċjali tal-UE għandha tiġi tradotta għall-Ingliż.
English: • Potential impact of possible regulatory actions on therapeutic practice and availability of treatments.
Maltese: • L-impatt potenzjali ta' azzjonijiet regolatorji possibbli dwar prattika terapewtika u disponibilità ta'
English: The Agency processes personal data in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.
Maltese: L-Aġenzija tipproċessa d-dejta personali skont ir-Regolament (KE) Nru 45/2001 tal-Parlament Ewropew u tal-Kunsill tat18 ta' Diċembru 2000 dwar il-protezzjoni ta' individwu fir-rigward tal-ipproċessar ta' dejta personali mill-istituzzjonijiet u lkorpi tal-Komunità u dwar il-moviment liberu ta' dak id-dejta.
English: Public hearings can add various elements to the considerations of the PRAC.
Maltese: Is-seduti ta' smigħ pubbliku jistgħu jżidu elementi varji għall-konsiderazzjonijiet tal-PRAC.
English: Modalities of participation
Maltese: 3.2. Modalitajiet ta' parteċipazzjoni
English: At the end of the interventions the PRAC Chair summarises the interventions heard.
Maltese: Fl-aħħar tal-interventi, il-President tal-PRAC ser jagħmel sommarju tal-interventi li jkunu nstemgħu.
English: The primary purpose of a public hearing is to hear the public's view on the acceptability of the risks associated with the medicinal product/medicinal substance/class of medicinal products concerned, particularly in relation to its therapeutic effects and therapeutic alternatives available, as well as to seek suggestions and recommendations on the feasibility and acceptability of risk management and minimisation activities.
Maltese: L-għan ewlieni ta' seduta ta' smigħ pubbliku huwa sabiex tisma' l-opinjoni tal-pubbliku dwar laċċettabilità tar-riskji assoċjati mal-prodott mediċinali/sustanza medika/klassi ta' prodotti mediċinali ikkonċernata, b'mod partikolari fir-rigward tal-effetti terapewtiċi tagħha u alternattivi terapewtiċi disponibbli, kif ukoll sabiex tfittex suġġerimenti u rakkomandazzjonijiet dwar il-fattibbiltà u laċċettabilità tal-ġestjoni tar-riskju u l-attivitajiet ta' minimizzazzjoni.
English: • Speakers can make an intervention in person or via teleconferencing facilities (Adobe Connect) where possible and feasible (See section 3.3 for more information on how to submit a request to participate as a speaker).
Maltese: • Il-kelliema jistgħu jagħmlu intervent personalment jew permezz ta' faċilitajiet ta' telekonferenzi (Adobe Connect) fejn possibbli u fattibbli (Ara sezzjoni 3.3 għal aktar informazzjoni dwar kif tippreżenta talba sabiex tipparteċipa bħala kelliem).
English: The PRAC Chair opens the public hearing.
Maltese: Il-President tal-PRAC jiftaħ is-seduta ta' smigħ pubbliku.
English: Further information is provided on the Agency's website under “Privacy statement”.
Maltese: Aktar informazzjoni hija pprovduta fuq is-sit elettroniku talAġenzija taħt "Stqarrija ta' privatezza".
English: • A list of specific questions on which information from the public is sought during the public hearing.
Maltese: • Lista ta' mistoqsijiet speċifiċi dwar liema informazzjoni mill-pubbliku hija mfittxija waqt is-seduta ta' smigħ pubbliku.
English: The public hearing will be chaired by the PRAC Chair.
Maltese: Is-seduta ta' smigħ pubbliku ser tkun ippreseduta mill-President tal-PRAC.
English: The value of a public hearing is considered to be greater in that phase of the process where the PRAC has assessed the scientific evidence coming from different sources and where different regulatory options to manage and/or minimise risks are to be considered in a wider public health context, before reaching its conclusion.
Maltese: ivvaluta l-evidenza xjentifika li ġejja minn sorsi differenti u fejn għażliet regolatorji differenti għal ġestjoni u/jew minimizzazzjoni tar-riskji għandhom jiġu kkunsidrati f'kuntest tas-saħħa pubblika usa'.
English: • General ground rules guiding the public hearing.
Maltese: • Regoli fundamentali ġenerali li jiggwidaw is-seduta ta' smigħ pubbliku.
English: • Affiliation (i.e. name of the organisation/pharmaceutical company the individual represents), if applicable.
Maltese: • Affiljazzjoni (jiġifieri l-isem tal-organizzazzjoni/kumpanija tal-farmaċewtika li l-individwu jirrapreżenta), jekk applikabbli.
English: If they are unable to present in English, the European Medicines Agency (hereafter referred to as “Agency”) will provide translation from the official EU languages into English.
Maltese: Jekk mhumiex kapaċi jippreżentaw bl-Ingliż, l-Aġenzija Ewropea għall-Mediċini (minn issa 'l quddiem issir referanza għaliha bħala "Aġenzija") sejra tipprovdi traduzzjoni mil-lingwi uffiċjali tal-UE għall-Ingliż.
English: • Agency's contact email address and phone number.
Maltese: • Indirizz tal-email tal-kuntatt tal-Aġenzija u numru tat-telefown.
English: A public hearing is a forum to which the public is invited to express its views, guided by a pre-defined set of questions, on issues related to the safety of a particular medicinal product, a medicinal substance or a therapeutic class, whilst also considering the therapeutic effects of these products.
Maltese: Seduta ta' smigħ pubbliku hija forum li għaliha il-pubbliku huwa mistieden sabiex jesprimi l-opinjonijiet tiegħu, iggwidat minn sett ta' mistoqsijiet iddefiniti minn qabel, dwar kwistjonijiet relatati massikurezza ta' prodott mediċinali, sustanza mediċinali jew klassi terapewtika partikolari, filwaqt ki jitqiesu wkoll l-effetti terapewtiċi ta' dawn il-prodotti.
English: Decision to hold a public hearing
Maltese: Min jista' jattendi seduta ta' smigħ pubbliku
English: The contributions made by the public during a public hearing will be considered by the PRAC.
Maltese: Il-kontribuzzjonijiet li saru mill-pubbliku waqt is-seduta ta' smigħ pubbliku sejrin jitqiesu millPRAC.
English: Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)
Maltese: Regoli ta' proċedura dwar l-organizzazzjoni u t-twettiq ta' seduti ta' smigħ pubbliku fil-Kumitat dwar il-Valutazzjoni tar-Riskji fil-qasam tal-Farmakoviġilanza (PRAC)
English: If the number of requests still exceeds the allocated time, the Agency will review the requests and decide on the list of speakers, taking into account elements such as the most relevant speakers with regard to the questions to be addressed at the public hearing and/or the geographical spread of the speakers.
Maltese: Jekk in-numru ta' talbiet xorta jaqbeż il-ħin allokat, l-Aġenzija sejra tirrevedi t-talbiet u tiddeċiedi dwar il-lista ta' kelliema, fejn tqis elementi bħal l-aktar kelliema rilevanti fir-rigward tal-mistoqsijiet li għandhom jiġu indirizzati fis-seduta ta' smigħ pubbliku u/jew il-firxa ġeografika tal-kelliema.
English: Following the opening of the public hearing, the PRAC Rapporteur and/ or PRAC Co-Rapporteur give(s) an overview of the procedure, including the main issues and present(s) the questions on which public input is sought.
Maltese: Wara l-ftuħ tas-seduta ta' smigħ pubbliku, ir-Rapporteur tal-PRAC u/jew il-Co-Rapporteur tal-PRAC jagħti(u) ħarsa ġenerali tal-proċedura, inkluż il-kwistjonijiet ewlenin u jippreżenta(w) il-mistoqsijiet li dwarhom qiegħda tiġi mfittxija l-kontribuzzjoni tal-pubbliku.
English: Where a marketing authorisation holder or another person intending to submit information has confidential data relevant to the subject matter of the procedure, he may request permission to present that data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.”
Maltese: Fejn detentur ta' awtorizzazzjoni għat-tqegħid fis-suq jew persuna oħra li biħsiebha tressaq xi tagħrif ikollha dejta kunfidenzjali rilevanti mas-suġġett tal-proċedura, hija tista' titlob permess li tressaq dik id-dejta lill-Kumitat dwar il-Valutazzjoni tar-Riskji fil-qasam tal-Farmakoviġilanza f'seduta ta' smigħ mhux pubblika."
English: A record of the meeting, the list of speakers and all other participants, including their affiliation, their declared interests, any supporting documentation presented by speakers and a summary of the conclusions of the meeting will be made available following the public hearing on the Agency's website.
Maltese: Reġistrazzjoni tal-laqgħa, il-lista tal-kelliema u l-parteċipanti l-oħrajn kollha, inkluż l-affiljazzjoni tagħhom, l-interessi ddikjarati tagħhom, kwalunkwe dokument ta' appoġġ ippreżentat mill-kelliema u sommarju tal-konklużjonijiet tal-laqgħa ser ikun disponibbli wara s-seduta ta' smigħ pubbliku fuq is-sit elettroniku tal-Aġenzija.
English: The marketing authorisation holder(s) has/have the opportunity to present its/their view(s) to the participants of the public hearing.
Maltese: Id-detentur(i) ta' awtorizzazzjoni għat-tqegħid fis-suq għandu/għandhom l-opportunità li jippreżentaw l-opinjoni(jiet) tiegħu/tagħhom lill-parteċipanti tas-seduta ta' smigħ pubbliku.
English: The PRAC Chair, in collaboration with Agency staff, is responsible for the preparation of the public hearing and the conduct of the public hearing and shall take appropriate measures to ensure that the public hearing is run effectively and efficiently.
Maltese: Il-President tal-PRAC, f'kollaborazzjoni mal-persunal tal-Aġenzija, huwa responsabbli għat-tħejjija tasseduta ta' smigħ pubbliku u t-tmexxija tas-seduta ta' smigħ pubbliku u għandu jieħu l-miżuri xierqa sabiex jiżgura li s-seduta ta' smigħ pubbliku issir b'mod effettiv u effiċjenti.
English: The Agency shall, in consultation with the parties concerned, draw up rules of procedure on the organisation and conduct of public hearings, in accordance with Article 78 of Regulation (EC) No
Maltese: L-Aġenzija, b'konsulazzjoni mal-partijiet ikkonċernati, għandha tfassal Regoli ta' Proċedura dwar l-organizzazzjoni u t-twettiq ta' seduti ta' smigħ pubbliku, bi qbil mal-Artikolu 78 tar-Regolament (KE) Nru 726/2004.
English: The outcome of the discussion on the need to hold a public hearing, including a justification of the decision taken will be recorded in the minutes of the PRAC which are published on the Agency's website.
Maltese: Ir-riżultat tad-diskussjoni dwar il-ħtieġa li ssir seduta ta' smigħ pubbliku, inkluż ġustifikazzjoni taddeċiżjoni meħuda sejrin jitniżżlu fil-minuti tal-PRAC li huma ppubblikati fuq is-sit elettroniku talAġenzija.
English: In the public hearing, due regard shall be given to the therapeutic effect of the medicinal product.
Maltese: Fis-seduta ta' smigħ għandha tingħata attenzjoni xierqa lill-effett terapewtiku tal-prodott mediċinali.
English: • Capacity (i.e. whether the person is speaking as a patient or carer, a healthcare professional, an academic or a representative of the pharmaceutical industry, irrespective of whether the person speaks as an individual or a representative of an organisation/pharmaceutical company).
Maltese: irrispettivament minn jekk il-persuna titkellimx bħala individwu jew bħala rappreżentant ta' organizzazzjoni/kumpanija tal-farmaċewtika).