FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint was overall response rate defined as the percentage of patients who achieved an objective confirmed complete response or partial response based on an independent, central, blinded radiological review using RECIST (Version 1.0).
Maltese: II-punt aħħari tal-effikaċja primarja kienet ir-rata tar-rispons globali, definit bħala l-perċentwali ta' pazjenti li kisbu rispons sħiħ oġġettiv ikkonfermat jew rispons parzjali bbażat fuq evalwazzjoni indipendenti, ċentrali, blinded, bl-użu ta' RECIST (verżjoni 1.0).
English: Hepatobiliary disorders Common: Cholangitis
Maltese: Komuni: Newtropenja bid-deni, limfopenija
English: Very common: Fatigue, oedema peripheral, pyrexia, asthenia, chills Common: Infusion site reaction
Maltese: Komuni ħafna: Għeja, edema periferali, deni, astenja, tertir ta' bard Komuni: Reazzjoni fis-sit tal-infużjoni
English: Following intravenous administration of radiolabelled paclitaxel to rats on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations.
Maltese: Wara lgħoti ġol-vini ta' paclitaxel radjutikkettat lil firien f'jiem 9 sa 10 wara t-twelid, il-konċentrazzjonijiet ta' radjuattività fil-ħalib kienu ogħla milli fil-plażma u naqsu b'mod parallel mal-konċentrazzjonijiet fil-plażma.
English: Of the 431 patients with pancreatic adenocarcinoma who were randomized to receive Abraxane in combination with gemcitabine, the majority (93%) were white, 4% were black and 2% were Asian.
Maltese: Mill-431 pazjent b'adenokarċinoma tal-frixa li ntgħażlu b'mod każwali biex jirċievu Abraxane flimkien ma' gemcitabine, il-parti l-kbira tagħhom (93%) kienu bojod, 4% kienu suwed u 2% kienu Asjatiċi. 16% kellhom Stat tal-Prestazzjoni ta' Karnofsky (KPS) ta' 100; 42% kellhom KPS ta' 90;
English: If you are given other medicines as part of your treatment, you should ask your doctor for advice on driving and using machines.
Maltese: Disgħa u ħamsin fil-mija rċivew il-prodott mediċinali li kien qed ikun studjat bħala t-tieni terapija jew iktar mit-tieni terapija.
English: In some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae have been reported as part of the continuing surveillance of Abraxane.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq il-kunjett wara EXP.
English: Patients 75 years and older
Maltese: Pazjenti ta' 75 sena jew iktar
English: Common: Vertigo Uncommon: Ear pain, tinnitus
Maltese: ras, sturdament Mhux komuni: Paralisi tas-VII nerv
English: Table 13: Non-inferiority analyses on progression-free survival and overall survival in randomized non-small cell lung cancer trial (intent-to-treat population)
Maltese: Tabella 13: Analiżijiet ta' noninferjorità f'sopravivenza ħielsa mill-progressjoni u sopravivenza globali fi prova dwar kanċer tal-pulmun ta' ċelluli mhux żgħar li fiha l-parteċipanti ntgħażlu b'mod każwali (popolazzjoni b'intenzjoni li tiġi kkurata)
English: APPROPRIATE
Maltese: Stabbiltà
English: • Weakness and tiredness, fever
Maltese: • Diffikultà biex timxi, nefħa
English: When reconstituted, each ml of Abraxane concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Maltese: Meta rikostitwit, kull ml ta' konċentrat ta' Abraxane ikun fih 0.183 mmol ta' sodium, li hu 4.2 mg ta' sodium.
English: • Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)
Maltese: • Għajnejn irritati, uġigħ fl-għajnejn, għajnejn ħomor, ħakk fl-għajnejn, vista doppja, tnaqqis fil vista, jew tara dwal bħal leħħa ta' berqa, vista mċajpra minħabba nefħa fir-retina (edema makulari ċistojde)
English: Patients received a median treatment duration of 3.9 months in the Abraxane/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the Abraxane/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Maltese: 32% tal-pazjenti fil-parti tal-istudju b' Abraxane/gemcitabine meta mqabbla ma' 15% tal-pazjenti fil-parti tal-istudju b'gemcitabine irċivew kura ta' 6 xhur jew aktar.
English: Overall Response Rate Confirmed complete or partial overall response, n (%)
Maltese: Numru ta' mwiet, n (%)
English: Albumin is known to mediate endothelial caveolar transcytosis of plasma constituents, and in vitro studies demonstrated that the presence of albumin in Abraxane enhances transport of paclitaxel across endothelial cells.
Maltese: Dan il-prodott mediċinali m'għandux bżonn l-ebda kundizzjoni ta' temperatura speċjali għall-ħażna.
English: Administer reconstituted Abraxane suspension intravenously using an infusion set incorporating a 15 µm filter.
Maltese: Tagħtix is-suspensjoni rikostitwita jekk tara materjal solidu fil-kunjett.
English: Based on the published literature, in vitro studies of binding to human serum proteins, (using paclitaxel at concentrations ranging from 0.1 to 50 µg/ml), indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel.
Maltese: Ibbażat fuq il-letteratura ppubblikata, studji in vitro tal-għaqda ma' proteini fis-serum uman, (bl-użu ta' paclitaxel f'konċentrazzjonijiet li jvarjaw minn 0.1 sa 50 µg/ml), jindikaw li l-preżenza ta'
English: 3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving Abraxane monotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Maltese: Il-frekwenza ta' pulmonite hija kkalkulata fuq bażi ta' dejta f'1310 pazjent fi provi kliniċi li rċivew monoterapija b'Abraxane għall-kanċer fis-sider u għal indikazzjonijiet oħra bl-użu tal-mard interstizjali tal-pulmun MedDRA SMQ. Ara sezzjoni 4.4.
English: NAME OF THE MEDICINAL PRODUCT Abraxane 5 mg/ml powder for suspension for infusion.
Maltese: Abraxane 5 mg/ml trab għal suspensjoni għall-infużjoni.
English: Treatment effects on OS favoured the Abraxane/gemcitabine arm across the majority of pre-specified subgroups (including gender, KPS, geographic region, primary location of pancreatic cancer, stage at diagnosis, presence of liver metastases, presence of peritoneal carcinomatosis, prior Whipple procedure, presence of biliary stent at baseline, presence of pulmonary metastases, and number of metastatic sites).
Maltese: L-effetti tal-kura fuq l-OS iffavoriet il-parti tal-istudju dwar Abraxane/gemcitabine fil-maġġoranza tas-sottogruppi speċifikati minn qabel (li jinkludu s-sess tal-persuna, KPS, ir-reġjun ġeografiku, il-post primarju tal-kanċer tal-frixa, l-istadju meta tkun saret id-dijanjosi, il-preżenza ta' metastasi fil-fwied, il-preżenza ta' karċinomatożi peritoneali, proċedura Whipple fil-passat, il-preżenza ta' stent filmarrara fil-linja bażi, il-preżenza ta' metastasi fil-pulmun, u numru ta' postijiet metastatiċi).
English: Rare reports of congestive heart failure and left ventricular dysfunction have been observed among individuals receiving Abraxane.
Maltese: Rapporti rari ta' insuffiċjenza konġestiva tal-qalb u disfunzjoni tal-ventrikulu tax-xellug kienu osservati fost individwi li kienu qed jingħataw Abraxane.
English: There are insufficient data available to recommend dose modifications of Abraxane in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min) (see section 5.2).
Maltese: M'hemmx dejta biżżejjed disponibbli biex isiru rakkomandazzjonijiet dwar modifikazzjonijiet fid-doża ta' Abraxane f'pazjenti b'indeboliment sever tal-kliewi jew mard tal-kliewi fl-aħħar stadju (tneħħija stmata talkrejatinina ta' <30 ml/min) (ara sezzjoni 5.2).
English: Seventy-seven percent of the patients had been previously exposed to anthracyclines.
Maltese: Sebgħa u sebgħin fil-mija tal-pazjenti kienu esposti fil-passat għal anthracyclines.
English: The common side effects may affect up to 1 in 10 people:
Maltese: L-effetti komuni jistgħu jaffettwaw sa 1 minn kull 10 persuni:
English: • medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic),
Maltese: • mediċini għall-kura ta' infezzjonijiet (i.e. antibijotiċi bħal erythromycin, rifampicin, eċċ.; staqsi lit-tabib, lill-infermier jew lill-ispiżjar tiegħek jekk ma tkunx ċerta jekk il-mediċina li qed tieħu hix antibijotiku), u dawn jinkludu mediċini għall-kura ta' infezzjonijiet fungali (eż.
English: Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with Abraxane in combination with gemcitabine.
Maltese: Tabella 7 telenka r-reazzjonijiet avversi f'pazjenti b'adenokarċinoma tal-frixa kkurati b'Abraxane flimkien ma' gemcitabine.
English: Survival (months) Progression-free Survival Death or progression, n (%) Median Progression-free Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
Maltese: Sopravivenza Globali (xhur) Sopravivenza mingħajr Progressjoni Mewt jew progressjoni, n (%) Medjan ta' Sopravivenza mingħajr Progressjoni, xhur (95% CI)
English: Abraxane is supplied as a sterile lyophilised powder for reconstitution before use.
Maltese: Abraxane jiġi bħala trab lajofilizzat sterili li għandu jkun ippreparat qabel l-użu.
English: 31 March 2026
Maltese: 31 ta' Marzu 2026
English: Each MAH shall conduct and submit for their medicinal product(s) the results of placebo-controlled, double-blind multicentre RCT(s) according to agreed protocols in order to further characterise the efficacy and safety, of their bacterial lysate based product(s) in their authorised indication(s).
Maltese: Kull MAH għandu jwettaq u jissottometti għall-prodott(i) mediċinali tiegħu r-riżultati ta' RCT(s) ikkontrollat(i) bi plaċebo double-blind, multiċentriku(ċi) skont il-protokolli li ntlaħaq qbil dwarhom sabiex jiġu kkaratterizzati aktar l-effikaċja u s-sigurtà, tal-prodott(i) tagħhom ibbażat(i) fuq liżati batteriċi fl-indikazzjoni(jiet) awtorizzata(i) tagħhom.
English: The clinical study report should be submitted to the relevant National Competent Authorities by:
Maltese: Ir-rapport tal-istudju kliniku għandu jiġi sottomess lill-Awtoritajiet Nazzjonali Kompetenti rilevanti sal-:
English: The protocols should be agreed with the relevant NCAs.
Maltese: Għandu jintlaħaq qbil mal-NCAs rilevanti.
English: The study population should be representative for the authorised indication(s).
Maltese: Il-popolazzjoni tal-istudju għandha tkun rappreżentattiva għall-indikazzjoni(jiet) awtorizzata(i).
English: The marketing authorisation holders shall complete the below condition, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom itemmu l-kundizzjoni ta' hawn taħt, fiż-żmien stipulat, u l-awtoritajiet kompetenti għandhom jiżguraw li dan li ġej ikun issodisfat:
English: A preliminary publication in 1343 women has been provided by the MAH.
Maltese: Il-MAH ipprovda pubblikazzjoni preliminari f'1343 mara.
English: The product is currently approved in Sweden, Denmark, Finland, Iceland and Norway.
Maltese: Bħalissa l-prodott huwa approvat fl-Isvezja, fid-Danimarka, fil-Finlandja, fl-Islanda u fin-Norveġja.
English: - The second organisation (Marie Stopes International Australia) has set up a pre-launch training program in Australia under Therapeutic Goods Administration (TGA) Authorised Prescriber Program.
Maltese: - It-tieni organizzazzjoni (Marie Stopes International Australia) waqqfet programm ta' taħriġ ta' qabel it-tnedija fl-Awstralja taħt il-Programm ta' Dawk li Jippreskrivu Awtorizzati għall-Amministrazzjoni talOġġetti Terapewtiċi (TGA).
English: The posology is different to the reference product Mifegyne.
Maltese: Il-pożoloġija hija differenti millprodott ta' referenza Mifegyne.
English: The application for Mifepristone Linepharma 200 mg tablets is a hybrid application made according to Article 10(3) of Directive 2001/83/EC, with Mifegyne 200 mg tablet as reference product.
Maltese: L-applikazzjoni għall-pilloli ta' Mifepristone Linepharma 200 mg hija applikazzjoni ibrida magħmula skont l-Artikolu 10(3) tad-Direttiva 2001/83/KE, bil-pillola ta' Mifegyne 200 mg bħala l-prodott ta' referenza.
English: The two bioequivalence studies were performed against Mifegyne (approved in EEA) and Mifeprex (approved in the USA).
Maltese: Iż-żewġ studji ta' bijoekwivalenza saru f'konfront ma' Mifegyne (approvat fiż-ŻEE) u Mifeprex (approvat fl-Istati Uniti tal-Amerika).
English: - The organisation Gynuity Health Projects performed a GCP-compliant study in Mexico in 1000 women (open-label, non-comparative, prospective multi-site study of mifepristone 200 mg followed 24-48 hours later by buccal misoprostol 800 mcg for termination of pregnancy through 63 days).
Maltese: - L-organizzazzjoni Gynuity Health Projects wettqet studju konformi mal-GCP fil-Messiku f'1000 mara (studju prospettiv f'diversi postijiet, bit-tikketta mikxufa, mhux komparattiv b'mifepristone 200 mg segwit 24-48 siegħa wara ta' misoprostol 800 mcg mill-ħalq għat-terminazzjoni tat-tqala għal 63 jum).
English: Mifepristone Linepharma is submitted as a hybrid application.
Maltese: Mifepristone Linepharma huwa ppreżentat bħala applikazzjoni ibrida.
English: The success rate is of 97.3%, comparable to studies reported in published literature.
Maltese: Ir-rata ta' suċċess hija ta' 97.3%, komparabbli malistudji rrapportati fir-riċensjoni ppubblikata.
English: Bioequivalence with the reference product (Mifegyne) was demonstrated for AUC while the Cmax was slightly above the conventional acceptance range of 80-125% (the Cmax ratio (90% CI) was 114.4 (103.33-126.66)).
Maltese: Il-bijoekwivalenza mal-prodott ta' referenza (Mifegyne) intweriet għall-AUC filwaqt li s-Cmax kien kemxejn ogħla mill-medda ta' aċċettazzjoni konvenzjonali ta' 80-125% (il-proporzjon tas-Cmax (90% CI) kien 114.4
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Council Directive 2001/83/EC;
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-referenza mqajma minn Franza taħt l-Artikolu 29(4) tadDirettiva tal-Kunsill 2001/83/KE;
English: The clinical documentation submitted by the MAH to support this article 10(3) application includes clinical data and supportive pharmacokinetic data in the form of two bioequivalence studies.
Maltese: Id-dokumentazzjoni klinika ppreżentata mill-MAH b'appoġġ għal din l-applikazzjoni skont lArtikolu 10(3) tinkludi dejta klinika u dejta farmakokinetika ta' appoġġ fil-forma ta' żewġ studji dwar ilbijoekwivalenza.
English: The current SmPC for the reference product mifepristone recommends mifepristone at the dose of 600 mg followed 36 to 48 hours later by 400 µg misoprostol orally or gemeprost 1 mg per vaginam for pregnancy termination up to 49 days of amenorrhea.
Maltese: L-SmPC attwali għall-prodott ta' referenza mifepristone jirrakkomanda mifepristone fid-doża ta' 600 mg segwit minn 400 µg misoprostol oralment jew gemeprost 1 mg mill-vaġina 36 sa 48 siegħa wara għatterminazzjoni tat-tqala sa 49 jum ta' amenorreja.
English: The approved indication for Mifepristone Linepharma through the initial Mutual Recognition Procedure is “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea”.
Maltese: L-indikazzjoni approvata għal Mifepristone Linepharma permezz tal-Proċedura inizjali ta' Rikonoxximent Reċiproku hija “Terminazzjoni medika ta' tqala li tkun qiegħda tiżviluppa fl-utru f'kombinazzjoni sekwenzjali ma' analogu ta' prostaglandin sa 63 jum ta' amenorreja”.
English: Overall summary of the scientific evaluation of Mifepristone Linepharma and associated names (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Mifepristone Linepharma u ismijiet assoċjati (ara l-Anness I)
English: Based on the above, the CHMP considers that the overall efficacy and safety profile of the Mifepristone Linepharma has been sufficiently proven by the studies presented and therefore concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indication “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea” is favourable.
Maltese: Abbażi ta' dan li ntqal, is-CHMP jikkunsidra li l-profil tal-effikaċja u s-sigurtà globali ta' Mifepristone Linepharma kien ippruvat b'mod suffiċjenti mill-istudji ppreżentati u għalhekk ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju għal Mifepristone Linepharma fl-indikazzjoni tal-applikazzjoni “Terminazzjoni medika ta' tqala li tkun qiegħda tiżviluppa fl-utru f'kombinazzjoni sekwenzjali ma' analogu ta' prostaglandin sa 63 jum ta' amenorreja” huwa favorevoli.
English: During the repeat use procedure potential serious risk to public health was raised by the France as bioequivalence with the reference product had not been demonstrated for Cmax.
Maltese: Waqt il-proċedura ta' użu ripetut, Franza qajmet ir-riskju serju potenzjali għas-saħħa pubblika minħabba li l-bijoekwivalenza mal-prodott ta' referenza ma ntwerietx għas-Cmax.
English: The reason for this alternative was the fact that the combination of 200 mg mifepristone with oral misoprostol was associated with a potentially higher risk of continuing pregnancy, whereas 1mg gemeprost vaginally had been demonstrated in many studies to provide a strong prostaglandin action also in combination with a lower dose of mifepristone.
Maltese: Ir-raġuni għal din l-alternattiva kienet il-fatt li lkombinazzjoni ta' 200 mg mifepristone ma' misoprostol orali kienet assoċjata ma' riskju potenzjalment ogħla ta' tkomplija tat-tqala, filwaqt li 1 mg gemeprost mill-vaġina ntwera f'diversi studji li jipprovdi azzjoni qawwija ta' prostaglandin ukoll flimkien ma' doża aktar baxxa ta' mifepristone.
English: In addition, the MAH provided supportive pharmacokinetic data in the form of two bioequivalence studies.
Maltese: Barra minn hekk, il-MAH ipprovda dejta farmakokinetika ta' appoġġ fil-forma ta' żewġ studji dwar ilbijoekwivalenza.
English: This program is on-going and overall from 01 September 2009 to 30 June 2011, 12,830 women have been exposed.
Maltese: Dan il-programm għadu għaddej u b'kollox mill-1 ta' Settembru 2009 sat-30 ta' Ġunju 2011, ġew esposti 12,830 mara.
English: • The Committee reviewed all available data submitted by the marketing authorisation holder to address the potential serious risk to public health, in particular the efficacy and safety in respect of the 200 mg Mifepristone Linepharma dosing regimen;
Maltese: • Il-Kumitat irreveda d-dejta kollha disponibbli ppreżentata mid-detentur tal-awtorizzazzjoni għattqegħid fis-suq sabiex jindirizza r-riskju serju potenzjali għas-saħħa pubblika, b'mod partikolari leffikaċja u s-sigurtà tal-iskeda ta' dożar ta' 200 mg ta' Mifepristone Linepharma;
English: The CHMP is of the opinion that the marketing authorisation holder should submit a revised protocol to the national competent authorities, for final agreement prior the start of the clinical trial.
Maltese: Is-CHMP huwa tal-opinjoni li d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta protokoll rivedut lill-awtoritajiet nazzjonali kompetenti, għal qbil finali qabel ma tibda l-prova klinika.
English: Compared to Mifegyne, which could be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg is approved for Mifepristone Linepharma.
Maltese: Meta mqabbel ma' Mifegyne, li jista' jingħata kemm f'doża għolja ta' 600 mg kif ukoll f'doża aktar baxxa ta' 200 mg, id-doża l-baxxa ta' 200 mg biss hija approvata għal Mifepristone Linepharma.
English: During the following CMDh-referral procedure no consensus was reached and the CMDh referred the matter to the CHMP through an article 29(4) referral procedure.
Maltese: Waqt il-proċedura ta' referenza sussegwenti tas-CMDh ma ntlaħaq l-ebda kunsens u s-CMDh irrefera l-kwistjoni lis-CHMP permezz ta' proċedura ta' referenza tal-Artikolu 29(4).
English: Hence the CHMP is of the opinion that a revised protocol should be submitted to the national competent authorities, for final agreement prior the start of the clinical trial, as a condition to the marketing authorisation.
Maltese: Għaldaqstant is-CHMP huwa tal-opinjoni li għandu jiġi ppreżentat protokoll rivedut lill-awtoritajiet nazzjonali kompetenti, għal qbil finali qabel tibda l-prova klinika, bħala kundizzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq.
English: As proposed by the MAH at the time of the CMDh referral procedure, the protocol for the prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination was reviewed by the CHMP during the referral procedure.
Maltese: Kif propost mill-MAH fiż-żmien tal-proċedura ta' referenza tas-CMDh, il-protokoll għall-istudju ta' osservazzjoni prospettiv bl-għan li jiġu vvalutati r-rakkomandazzjonijiet ta' preskrizzjoni ta' Mifepristone Linepharma għat-terminazzjoni ta' tqala bikrija ġie rivedut mis-CHMP waqt il-proċedura ta' referenza.
English: The approved posology is 200 mg of mifepristone in a single oral dose, followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Maltese: Ġie approvat ukoll l-użu alternattiv ta' 200 mg ta' mifepristone f'doża waħda, sakemm din id-doża tkun segwita 36 sa 48 siegħa wara mill-għoti talanalogu tal-prostaglandin gemeprost 1 mg mill-vaġina.
English: In addition, the CHMP noted that the study with Mifeprex demonstrates bioequivalence for both AUC and Cmax.
Maltese: Dan il-protokoll kien imfassal sabiex jipprovdi aktar assigurazzjoni dwar is-sigurtà u l-effikaċja talprodott.
English: • Therefore the Committee concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indications is favourable, the CHMP has recommended the granting of the marketing authorisation subject to a recommended condition with regard to the safe and effective use of the medicinal product as set out in Annex IV and for which the amended sections of the summary of product characteristics and package leaflet are set out in Annex III for Mifepristone Linepharma and associated names (see Annex I).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda dejta dwar l-effikaċja klinika u s-sigurtà minn żewġ studji, li saru t-tnejn b'Mifepristone Linepharma fil-Messiku u fl-Awstralja rispettivament.
English: The marketing authorisation holder was in agreement with the amendments of the section 4.2 of the SmPC and section 3 of the Package Leaflet as proposed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq qabel mal-emendi tas-sezzjoni 4.2 tal-SmPC u sezzjoni 3 tal-Fuljett ta' Tagħrif kif propost mis-CHMP.
English: Compared to Mifegyne, which can be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg was approved for Mifepristone Linepharma through the first wave of the Mutual Recognition Procedure and was also being proposed in the current MRP repeated procedure.
Maltese: Imqabbel ma' Mifegyne, li jista' jingħata kemm f'doża għolja ta' 600 mg kif ukoll f'doża aktar baxxa ta' 200 mg, id-doża l-baxxa biss ta' 200 mg kienet approvata għal Mifepristone Linepharma permezz tal-ewwel fażi tal-Proċedura ta' Rikonoxximent Reċiproku u kienet qiegħda tkun proposta wkoll fil-proċedura ripetuta attwali tal-MRP.
English: (complete termination, no need for additional surgical procedure) was 96.7%.
Maltese: Filpopolazzjoni kollha, ir-rata ta' effikaċja (terminazzjoni sħiħa, bl-ebda ħtieġa ta' xi proċedura kirurġika oħra) kienet 96.7%.
English: EMA/281360/2012 EMEA/H/C/002369
Maltese: 26 ta' April 2012 EMA/281360/2012 EMEA/H/C/002369
English: What is Pioglitazone ratiopharm GmbH?
Maltese: X'inhu Pioglitazone ratiopharm GmbH?