FrancophonIA/ELRC3.0 huggingface dataset:
English: Arimidex is authorised in the EU via mutual recognition and national procedures.
Maltese: Arimidex huwa awtorizzat fl-UE permezz ta' rikonoxximent reċiproku u proċeduri nazzjonali.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Arimidex in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-aġenzija kkonkluda li hemm bżonn li l-informazzjoni dwar ilpreskrizzjoni ta' Arimidex tiġi armonizzata fl-Unjoni Ewropea (UE).
English: The company that markets Arimidex is AstraZeneca.
Maltese: Arimidex ma għandux jintuża f'nisa li:
English: The same dose is recommended in patients with mild liver problems or with mild to moderate kidney problems.
Maltese: L-istess doża hija rakkomandata f'pazjenti bi problemi tal-fwied ħfief jew bi problemi tal-kliewi ħfief għal moderati.
English: Decreasing the production of oestrogen is a way of suppressing the growth of the breast cancer because the growth of breast tissue is stimulated by oestrogen.
Maltese: It-tnaqqis tal-produzzjoni tal-estroġenu huwa mod ta' trażżin tat-tkabbir tal-kanċer tas-sider minħabba li t-tkabbir tat-tessut tas-sider huwa stimulat millestroġenu.
English: Procedure numbers: EMEA/H/C/000595/A-20/0026, EMEA/H/C/000336/A-20/0036, EMEA/H/C/000101/A-20/0051, EMEA/H/C/000502/A-20/0025, EMEA/H/C/000501/A-20/0024, EMEA/H/C/000759/A-20/0012, EMEA/H/C/000619/A-20/0015, EMEA/H/C/001180/A-20/0005, EMEA/H/C/001195/A-20/0001 and EMEA/H/A-31/001279
Maltese: Numri tal-proċeduri: EMEA/H/C/000595/A-20/0026, EMEA/H/C/000336/A-20/0036, EMEA/H/C/000101/A-20/0051, EMEA/H/C/000502/A-20/0025, EMEA/H/C/000501/A-20/0024, EMEA/H/C/000759/A-20/0012, EMEA/H/C/000619/A-20/0015, EMEA/H/C/001180/A-20/0005, EMEA/H/C/001195/A-20/0001 u EMEA/H/A-31/001279
English: Outcome of nine procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended1
Maltese: Riżultat ta' disa' proċeduri skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 u ta' proċedura waħda skont l-Artikolu 31 tadDirettiva 2001/83/KE kif emendata1
English: What are bisphosphonates?
Maltese: X'inhuma l-bisfosfonati?
English: The centrally authorised bisphosphonate-containing medicines concerned by these referrals are Aclasta and Zometa (zoledronic acid), Bondenza, Bonviva, Bondronat and Ibandronic acid Teva (ibandronic acid), and Adrovance and Fosavance (alendronic acid and vitamin D3).
Maltese: Il-mediċini li fihom il-bisfosfonati awtorizzati ċentralment ikkonċernati b'dawn ir-riferimenti huma Aclasta u Zometa (aċidu zoledroniku), Bondenza, Bonviva, Bondronat u Ibandronic acid Teva (aċidu ibandroniku), u Adrovance u Fosavance (aċidu alendroniku u l-vitamina D3).
English: Bisphosphonates include alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid.
Maltese: Il-bisfosfonati jinkludu l-aċidu alendroniku, l-aċidu clodronic, l-aċidu etidroniku, l-aċidu ibandroniku, laċidu neridroniku, l-aċidu pamidroniku, l-aċidu risedroniku, l-aċidu tiludroniku u l-aċidu zoledroniku.
English: In April 2010, the PhVWP noted that further data from both the published literature and postmarketing reports were now available that suggested that atypical stress fractures of the femur may be a class effect.
Maltese: F'April 2010, il-PhVWP innota li issa kienet disponibbli dejta ulterjuri kemm mil-letteratura ppubblikata kif ukoll mir-rapporti ta' wara tqegħid fis-suq li ssuġġeriet li fratturi atipiċi tal-femur minħabba stress jistgħu jkunu effett ta' klassi.
English: Why were bisphosphonates reviewed?
Maltese: Għaliex ġew riveduti l-bisfosfonati?
English: The current European public assessment reports for the nine centrally authorised medicines containing bisphosphonates concerned by these referrals (Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronic acid Teva, Vantavo and Zometa) can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Ir-rapporti pubbliċi Ewropej ta' valutazzjoni attwali għad-disa' mediċini awtorizzati ċentralment li fihom il-bisfosfonati kkonċernati b'dawn ir-riferimenti (Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronic acid Teva, Vantavo u Zometa) jistgħu jinstabu fuq is-sit elettroniku talAġenzija:
English: In 2008, the CHMP's Pharmacovigilance Working Party (PhVWP) noted that alendronic acid was associated with an increased risk of atypical fracture of the femur (thigh bone) that developed with low or no trauma.
Maltese: Fl-2008, il-Grupp ta' Ħidma tal-Farmakoviġilanza (PhVWP) tas-CHMP innota li l-aċidu alendroniku kien assoċjat ma' żieda fir-riskju ta' fratturi atipiċi tal-femur (l-għadma tal-koxxa) li żviluppaw permezz ta' trawma minuri jew mingħajr l-ebda trawma.
English: • Patients who are taking bisphosphonate-containing medicines need to be aware of the risk of atypical fracture of the thigh bone.
Maltese: • Il-pazjenti li qegħdin jieħdu mediċini li fihom il-bisfosfonati għandhom ikunu konxji mir-riskju ta' fratturi atipiċi fl-għadma tal-koxxa.
English: The Committee noted that the number of reports of atypical fractures of the femur in users of bisphosphonates had increased since the 2008 review.
Maltese: Il-Kumitat innota li n-numru ta' rapporti ta' fratturi atipiċi tal-femur fil-persuni li kienu għamlu użu millbisfosfonati kien żdied mir-reviżjoni tal-2008.
English: Consequently, on 20 September 2010, the UK Medicines Regulatory Agency asked the CHMP to issue an opinion on bisphosphonate-containing medicines and atypical stress fractures and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Maltese: Konsegwentement, fl-20 ta' Settembru 2010, l-Aġenzija Regolatorja tal-Mediċini tar-Renju Unit talbet lis-CHMP biex joħroġ opinjoni dwar il-prodotti mediċinali li fihom il-bisfosfonati u l-fratturi atipiċi minħabba stress u jekk l-awtorizzazzjoni għat-tqegħid fis-suq għal dawn il-mediċini għandhiex tinżamm, tiġi varjata, sospiża jew irtirata madwar l-UE.
English: It contains the active substance pemetrexed.
Maltese: Fih is-sustanza attiva pemetrexed.
English: The full EPAR for Alimta can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Alimta jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Alimta.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Alimta.
English: It is given once every three weeks as an infusion lasting 10 minutes.
Maltese: Jingħata darba kull tliet ġimgħat bħala infużjoni li ddum 10 minuti.
English: The gastrointestinal toxicities seen with Alimta are loss of appetite, nausea (feeling sick), vomiting, diarrhoea, constipation, pharyngitis (sore throat), and mucositis or stomatitis (inflammation of the lining of the digestive system and mouth).
Maltese: It-tossiċitajiet gastrointestinali li dehru b'Alimta huma nuqqas ta' aptit, nawżja (dardir), remettar, dijarea, stitikezza, farinġite (griżmejn misluħa), u mukożite jew stomatie (infjammazzjoni tal-inforra tas-sistema diġestiva u tal-ħalq).
English: What is Alimta?
Maltese: X'inhu Alimta?
English: How does Alimta work?
Maltese: X'benefiċċji wera Alimta matul l-istudji mwettqa?
English: In one maintenance treatment study, patients receiving Alimta lived for a further 4.3 months from the start of maintenance treatment without their cancer getting worse, compared with 2.6 months in those receiving placebo.
Maltese: Fi studju tal-kura ta' manteniment, il-pazjenti li ngħataw Alimta għexu 4.3 xhur iktar mill-bidu tal-kura ta' manteniment mingħajr ma l-kanċer aggrava, meta mqabbel ma' 2.6 xhur f'dawk li ngħataw plaċebo.
English: Patients receiving Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in those receiving cisplatin alone.
Maltese: Il-pazjenti li ngħataw Alimta u cisplatin damu ħajjin medja ta' 12.1 xahar, meta mqabbel ma' 9.3 xhur f'dawk li ngħataw biss cisplatin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Alimta on 20 September 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Alimta fl-20 ta' Settembru 2004.
English: In the second maintenance study, the figures were 4.1 months in the Alimta and 2.8 months in the placebo group.
Maltese: Fit-tieni studju tal-kura ta' manteniment, iċ-ċifri kienu 4.1 xhur b'Alimta u 2.8 xhur fil-grupp tal-plaċebo.
English: Why has Alimta been approved?
Maltese: Għaliex ġie approvat Alimta?
English: Alimta is used to treat two types of lung cancer:
Maltese: Alimta jintuża għall-kura ta' żewġ tipi ta' kanċer tal-pulmun:
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos),where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Maltese: • mesoteljoma plewrika malinnja (kanċer tar-rita tal-pulmun, normalment ikkawżat minn esponiment għall-ażbestos), fejn jintuża flimkien ma' ċisplatin f'pazjenti li ma ngħatawx il-kemoterapija qabel u li l-kanċer li għandhom ma jistax jitneħħa b'intervent kirurġiku;
English: For maintenance treatment, Alimta was compared with placebo (a dummy treatment) in two main studies involving 1,202 patients whose cancer had not got worse during platinum-based chemotherapy.
Maltese: Għall-kura ta' manteniment, Alimta tqabbel ma' plaċebo (trattament finta) f'żewġ studji ewlenin li involvew 1,202 pazjenti li kellhom kanċer li ma aggravax waqt il-kemoterapija bbażata fuq il-platinu.
English: For the treatment of locally advanced or metastatic non small cell lung cancer, Alimta was compared with gemcitabine (another anticancer medicine), in combination with cisplatin, in a study involving 1,725 patients who had not received chemotherapy before.
Maltese: Għal-kura tal-kanċer tal-pulmun mhux b'ċelloli żgħar lokalment avvanzat jew metastatiku, Alimta tqabbel ma' gemcitabine (mediċina oħra kontra l-kanċer), flimkien ma' ċisplatin, fi studju li involva 1,725 pazjent li ma kinux ingħataw kemoterapija qabel.
English: How has Alimta been studied?
Maltese: Kif ġie studjat Alimta?
English: When Alimta is given with cisplatin, an ‘anti emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Alimta jingħata ma' cisplatin, mediċina ‘antiemetika' (antiemetic - biex tipprevjeni r-remettar) u fluwidi (biex jipprevjenu d-diżidratazzjoni) għandha tingħata wkoll qabel jew wara d-doża ta' cisplatin.
English: Alimta was also compared with docetaxel (another anticancer medicine) in one study involving 571 patients who had received chemotherapy in the past.
Maltese: Alimta tqabbel ukoll ma' docetaxel (mediċina oħra kontra l-kanċer) fi studji li kien jinvolvi 571 pazjent li qatt ma kienu ngħataw kemoterapija.
English: In the treatment of non small cell lung cancer, Alimta was as effective as the comparators, with survival times around 10.3 months in patients who had not received chemotherapy in the past, and around 8.1 months in those who had received chemotherapy in the past.
Maltese: Fil-kura tal-kanċer tal-pulmun mhux b'ċelloli żgħar, Alimta kien effikaċi daqs il-mediċini ta' tqabbil, fejn iż-żmien kemm damu ħajjin kien ta' madwar 10.3 xhur f'pazjenti li qatt ma kienu ngħataw kemoterapija, u madwar 8.1 xhur f'dawk li kienu ngħataw kemoterapija qabel.
English: The most common side effects with Alimta, used on its own or with other anticancer medicines, are bone marrow suppression (when the bone marrow produces less blood cells than normal) and gastrointestinal toxicities (side effects affecting the stomach and gut).
Maltese: L-effetti sekondarji l-aktar komuni b'Alimta, meħud waħdu jew ma' mediċini oħrajn kontra l-kanċer, huma soppressjoni tal-mudullun (meta l-mudullun jipproduċi inqas ċelloli tad-demm min-normal) u tossiċitajiet gastrointestinali (effetti sekondarji li jaffettwaw l-istonku u l-imsaren).
English: The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Alimta, pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qed jimmultiplikaw, bħaċ-ċelloli tal-kanċer) li jagħmlu parti mill-grupp tal-‘antimetaboliti'.
English: For the treatment of malignant pleural mesothelioma, Alimta in combination with cisplatin has been compared with cisplatin alone in one main study in 456 patients who had not received chemotherapy for their disease before.
Maltese: Għal-kura ta' mesoteljoma plewrika malinja, Alimta flimkien ma' ċisplatin tqabbel ma' ċisplatin waħdu fi studju prinċipali wieħed fuq 456 pazjent li ma kinux ingħataw kemoterapija għall-marda tagħhom qabel.
English: What is the risk associated with Alimta?
Maltese: Għal xiex jintuża Alimta?
English: Alimta should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Maltese: Alimta għandu jingħata biss taħt is-supervizjoni ta' tabib bi kwalifiki fl-użu tal-kemoterapija.
English: The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Maltese: Id-doża rakkomandata ta' Alimta hija 500 mg għal kull metru kwadru tal-erja tas-superfiċje tal-ġisem (ikkalkulata permezz tat-tul u l-piż tal-pazjent).
English: The CHMP concluded that Alimta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' Alimta huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Maltese: Il-bidla ta' pemetrexed biex isir fil-forma attiva tiegħu ssir iktar malajr fiċċelloli tal-kanċer milli f'ċelloli normali, u dan iwassal għal livelli ogħla tal-forma attiva tal-mediċina u lazzjoni ddum iktar fiċ-ċelloli tal-kanċer.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Maltese: Jista' jintua wkollbħala kura ta' manteniment f'pazjenti li ngħataw kemoterapija bbażata fuq il-platinu.
English: • advanced ‘non small cell' lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received anticancer treatment.
Maltese: • kanċer tal-pulmun avvanzat ‘mhux b'ċelloli żgħar' tat-tip magħruf bħala ‘non-squamous', fejn jintuża jew flimkien ma' ċisplatin f'pazjenti li qatt ma kienu ngħataw kura qabel jew waħdu f'pazjenti li diġà ngħataw kura għal kontra l-kanċer.
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
Maltese: Dan iwassal biex il-forma attiva ta' pemetrexed tnaqqas il-veloċità tal-formazzjoni ta' DNA u RNA u jipprevjeni ċċellolli milli jimmultiplikaw.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Alimta.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u jingħataw injezzjonijiet ta' vitamina
English: Alimta is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Alimta huwa trab li jsir soluzzjoni għall-infużjoni (dripp fil-vina).
English: International non-proprietary name (INN): gentamicin
Maltese: Denominazzjoni internazzjonali komuni (INN): ġentamiċina
English: 11 February 2015
Maltese: 11 ta' Frar 2015
English: It is normally used as the sulphate salt.
Maltese: Normalment jintuża bħala l-melħ sulfat.
English: The Committee appointed K. Baptiste as rapporteur and C. Muñoz Madero as co-rapporteur.
Maltese: Muñoz Madero bħala korelatur.
English: Written explanations were provided by the applicants and marketing authorisation holders on 16 May 2014 and 4 September 2014.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mill-applikanti u d-detenturi talawtorizzazzjonijiet għat-tqegħid fis-suq fis-16 ta' Mejju 2014
English: On 14 February 2014, Denmark presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Maltese: Fl-14 ta' Frar 2014, id-Danimarka ppreżentat notifikazzjoni ta' referenza skont l-Artikolu 35 tadDirettiva 2011/82/KE lill-Aġenzija, fir-rigward ta' prodotti mediċinali veterinarji li fihom il-ġentamiċina ppreżentati bħala soluzzjonijiet għal injezzjoni biex jiġu amministrati liż-żwiemel.
English: Committee for Medicinal Products for Veterinary Use (CVMP)
Maltese: Il-Kumitat għall-prodotti mediċinali għall-użu veterinarju (CVMP)
English: The referral started on 12 March 2014.
Maltese: Ir-referenza nbdiet fit-12 ta' Marzu 2014.
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Maltese: Ġentamiċina huwa antibijotiku aminoglikosid indikat għall-kura ta' varjetà ta' infezzjonijiet batteriċi.
English: Opinion following an Article 351 referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses
Maltese: Opinjoni wara referenza għall-Artikolu 350F għal prodotti mediċinali veterinarji li fihom il-ġentamiċina ppreżentati bħala soluzzjonijiet għal injezzjoni biex jiġu amministrati liżżwiemel
English: It is also used in human medicine, usually as a solution for injection for intramuscular administration.
Maltese: Jintuża wkoll f'mediċina għall-bnedmin, normalment bħala soluzzjoni għal injezzjoni għal amministrazzjoni intramuskolari.
English: The CVMP was requested to harmonise the indications and dosing regimens of the concerned products, taking into account the available data and in particular with regard to the target animal safety.
Maltese: Is-CVMP intalab jagħti opinjoni fuq l-indikazzjonijiet u reġimi ta' dożaġġ għall-prodotti kkonċernati, b'kunsiderazzjoni tad-dejta disponibbli u partikolarment fir-rigward tas-sigurtà tal-annimal fil-mira.
English: Therefore, on 6 November 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Maltese: Għalhekk, fis-6 ta' Novembru 2014, il-Kumitat adotta b'kunsens opinjoni pożittiva, u rrakkomanda varjazzjonijiet fit-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti
English: Opinion following an Article 350F referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses EMA/106359/2015
Maltese: L-opinjoni finali nbidlet f'Deċiżjoni mill-Kummissjoni Ewropea fil-11 ta' Frar 2015.
English: In veterinary medicine gentamicin is used mainly as a solution for injection for pigs, cattle and horses and as an oral solution for poultry.
Maltese: F'mediċini veterinarji ġentamiċina jintuża l-iktar bħala soluzzjoni għal injezzjoni għal ħnieżer, frat u żwiemel u bħala soluzzjoni orali għat-tjur.
English: Version 10.1, 06/2019
Maltese: Verżjoni 10, 06/2019
English: It may harm them, even if their signs of illness are the same as yours.>
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar dan il-prodott mediċinali.
English: See section 4.>
Maltese: Ara sezzjoni 4.>
English: <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>
Maltese: <...> <6 xhur> <…> <sena> <18-il xahar> <sentejn> <30 xahar> <3 snin> <…>
English: <Traceability
Maltese: < Traċċabilità
English: <Environmental risk assessment (ERA)>
Maltese: <Valutazzjoni tar-riskju ambjentali (ERA)>
English: <{(Invented) name} is a biosimilar medicinal product.
Maltese: <{Isem (Ivvintat)} huwa prodott mediċinali bijoloġiku simili.
English: <Linearity/non-linearity>
Maltese: <Linearità/nuqqas ta' linearità>
English: X with <food> <and> <,> <drink> <and> <alcohol>
Maltese: X ma' <ikel><u> <,> <xorb> <u> <alkoħol>
English: < PC {number} [product code]
Maltese: < PC {numru} [kowd tal-prodott]
English: : +{Телефонен номер} <{e-mail}> Luxembourg/Luxemburg {Nom} <{Adresse} L-0000 {Localité/Stadt}> Tél/Tel: +{N° de téléphone/Telefonnummer} <{e-mail}>
Maltese: България {Име} <{Адрес} {Град} {Пощенски код}> Teл.: + {Телефонен номер} <{e-mail}> Luxembourg/Luxemburg {Nom} <{Adresse} L-0000 {Localité/Stadt}> Tél/Tel: + {N° de téléphone/Telefonnummer} <{e-mail}>
English: <For the full list of excipients, see section 6.1.>
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.>
English: <Pharmacokinetic/pharmacodynamic relationship(s)>
Maltese: <Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi)>
English: <The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.>
English: Deutschland {Name} <{Anschrift} D-00000 {Stadt}> Tel: +{Telefonnummer} <{e-mail}> Nederland {Naam} <{Adres} NL-0000 XX {stad}> Tel: +{Telefoonnummer} <{e-mail}>
Maltese: D-00000 {Stadt}> Tel: + {Telefonnummer} <{e-mail}> Nederland {Naam} <{Adres} NL-0000 XX {stad}> Tel: + {Telefoonnummer} <{e-mail}>
English: <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Maltese: <Data disponibbli hija deskritta fis-sezzjoni <4.8> <5.1> <5.2> iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.>
English: <The recommended dose is...>
Maltese: <Id-doża rakkomandata hija...>
English: Risk management plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (RMP)
English: 4.3 Contraindications
Maltese: Kontraindikazzjonijiet
English: <2.1 General description> [For advanced therapy products only]
Maltese: <2.1 Deskrizzjoni ġenerali>> [Għal prodott/i ta' terapija avvanzata biss]
English: The active substance(s) is (are)…
Maltese: Is-sustanza(i) attiva(i) hi (huma)…
English: Package leaflet: Information for the <patient> <user>
Maltese: Informazzjoni għall- <pazjent> <utent>
English: NN {number} [national reimbursement number or other national number identifying the medicinal product]>
Maltese: NN {numru} [numru tar-rimborż nazzjonali jew numru nazzjonali tal-identifikazzjoni ieħor għall-prodott mediċinali]>
English: Ελλάδα {Όνομα} <{Διεύθυνση} GR-000 00 {πόλη}> Τηλ: +{Αριθμός τηλεφώνου} <{e-mail}> Österreich {Name} <{Anschrift} A-0000 {Stadt}> Tel: +{Telefonnummer} <{e-mail}>
Maltese: Ελλάδα {Όνομα} <{Διεύθυνση} GR-000 00 {πόλη}> Τηλ: + {Αριθμός τηλεφώνου} <{e-mail}> Österreich {Name} <{Anschrift}
English: <Additional risk minimisation measures>
Maltese: < Miżuri addizzjonali għall-minimizzazzjoni tar-riskji >