FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: BICR=blinded independent central review; CI=confidence interval; CMH=CochranMantel-Haenszel; CR=complete response; IQR=interquartile range; ITT=intent-to-treat; ORR=objective response rate; OS=overall survival; PR=partial response; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1. a. Hazard ratio was based on stratified Cox regression model with treatment as the only covariate
Maltese: BICR=reviżjoni ċentrali indipendenti blinded; CI=intervall ta' kunfidenza; CMH=Cochran-Mantel-Haenszel; CR=rispons sħiħ;
English: Consistent with the overall results, a reduction in the risk of disease progression or death in favour of the talazoparib arm was observed in all individual patient subgroups (Figure 2).
Maltese: B'mod konsistenti mar-riżultati globali, ġie osservat tnaqqis fir-riskju ta' progressjoni tal-marda jew mewt favur il-fergħa ta' talazoparib fis-sottogruppi tal-pazjenti individwali kollha (Figura 2).
English: In repeat-dose toxicity studies in rats and in dogs, the main findings at subtherapeutic exposures included bone marrow hypocellularity with dose-dependent decrease in haematopoietic cells, depletion of lymphoid tissue in multiple organs and atrophy and/or degenerative changes in testes, epididymis and seminiferous tubules.
Maltese: Fi studji ta' effett tossiku minn dożi ripetuti fil-firien u l-klieb, is-sejbiet ewlenin ta' esponimenti subterapewtiċi inkludew ipoċellularità tal-mudullun bi tnaqqis dipendenti mid-doża f'ċelluli ematopoetiċi, tnaqqis ta' tessut tal-limfojde f'bosta organi u atrofija u/jew tibdil deġenerattiv fittestikoli, epididimiżi u tubuli seminiferużi.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg capsules talazoparib
Maltese: Talzenna 0.25 mg kapsuli talazoparib
English: The PK of talazoparib have not been studied in patients requiring haemodialysis (see section 4.2).
Maltese: Il-PK ta' talazoparib ma ġietx studjata f'pazjenti li kienu jeħtieġu emodijalisi (ara sezzjoni 4.2).
English: Population pharmacokinetic (PK) analysis has also shown that concomitant use of strong P-gp inhibitors increased talazoparib exposure by 45%, relative to talazoparib given alone.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni (PK) uriet ukoll li l-użu konkomitanti ta' inibituri qawwija ta' P-gp żied l-esponiment ta' talazoparib b'45%, relattiv għal talazoparib mogħti waħdu.
English: Talazoparib anti-tumour activity was also observed in a patient-derived xenograft (PDX) BRCA mutant breast cancer model where the patient was previously treated with a platinum-based regimen.
Maltese: Attività kontra t-tumur b'talazoparib ġiet osservata wkoll f'mudell tal-kanċer tas-sider b'mutazjoni BRCA fi xenograft derivat mill-pazjent (PDX, patient-derived xenograft) fejn il-pazjent ġie kkurat preċedentement b'kors ibbażat fuq il-platinu.
English: Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Maltese: Kull kapsula fiha talazoparib tosylate ekwivalenti għal 1 mg talazoparib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/005 (30 hard capsules)
Maltese: EU/1/19/1377/005 (30 kapsula iebsa)
English: Based on a population PK analysis that included 490 patients, where 118 patients had mild hepatic impairment (total bilirubin ≤ 1.0 × ULN and AST > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST), mild hepatic impairment had no effect on the PK of talazoparib.
Maltese: Abbażi ta' analiżi tal-PK tal-popolazzjoni li inkludiet 490 pazjent, fejn 118-il pazjent kellhom indeboliment tal-fwied ħafif (bilirubina totali ≤ 1.0 × ULN u AST > ULN, jew bilirubina totali > 1.0 sa 1.5 × ULN u kwalunkwe AST), indeboliment tal-fwied ħafif ma kellu l-ebda effett fuq il-PK ta' talazoparib.
English: Progression-free survival by BICR
Maltese: Sopravivenza mingħajr progressjoni skont ilBICR
English: Talzenna hard capsules come in different strengths.
Maltese: Talzenna kapsuli ibsin jiġu f'qawwiet differenti.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules
Maltese: Talzenna 0.25 mg kapsuli ibsin Talzenna 1 mg kapsuli ibsin
English: NAME OF THE MEDICINAL PRODUCT Talzenna 1 mg capsules talazoparib
Maltese: Talzenna 1 mg kapsuli ibsin talazoparib
English: Following a single oral dose of talazoparib with high-fat, high-calorie food (approximately 827 calories, 57% fat), the mean Cmax of talazoparib was decreased by approximately 46%, the median Tmax was delayed from 1 to 4 hours, while the AUCinf was not affected.
Maltese: Wara doża orali waħda ta' talazoparib ma' ikel b'ħafna xaħam, b'ħafna kaloriji (madwar 827 kalorija, 57% xaħam), isCmax medja ta' talazoparib naqset b'madwar 46%, it-Tmax medjan ittardja minn siegħa sa 4 sigħat, filwaqt li l-AUCinf ma ġietx affettwata.
English: Of the 431 patients randomised onto EMBRACA, 287 were randomised to the Talzenna arm and 144 to the chemotherapy arm. Randomisation was stratified by prior use of chemotherapy for metastatic disease (0 versus 1, 2, or 3), by triple-negative disease status (triple-negative breast cancer [TNBC] versus non-TNBC), and history of central nervous system metastasis (yes versus no).
Maltese: Ir-randomizzazzjoni ġiet stratifikata skont użu preċedenti ta' kimoterapija għal marda metastatika (0 kontra 1, 2, jew 3), skont status tal-marda triplu negattiv (kanċer tas-sider triplu negattiv [TNBC] kontra mhux TNBC), u storja ta' metatasi fis-sistema nervuża ċentrali (iva kontra le).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/006 (30 hard capsules)
Maltese: EU/1/19/1377/006 (30 kapsula iebsa)
English: Population PK analysis indicates that co-administration of acid-reducing agents including proton pump inhibitors and histamine receptor 2 antagonists (H2RA), or other acid-reducing agents had no significant impact on the absorption of talazoparib.
Maltese: Analiżi tal-PK tal-popolazzjoni tindika li l-għoti flimkien ta' sustanzi li jnaqqsu l-aċidu inkluż inibituri tal-pompa tal-proton u antagonisti tar-riċettur 2 tal-istamina (H2RA, histamine receptor 2 antagonists), jew sustanzi oħra li jnaqqsu l-aċidu ma kellhom l-ebda impatt sinifikanti fuq l-assorbiment ta' talazoparib.
English: Thrombocytopeniaa Anaemiab Neutropeniac Leucopeniad
Maltese: Tossikoloġija tal-iżvilupp
English: No dose adjustment is necessary in elderly (≥ 65 years of age) patients (see section 5.2).
Maltese: Anzjani L-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti anzjani (età ta' ≥ 65 sena) (ara sezzjoni 5.2).
English: Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.
Maltese: Talzenna jintuża biex jikkura adulti b'kanċer tas-sider ta' tip magħruf bħala kanċer tas-sider negattiv għall-HER2 li għandhom ġene BRCA li tintiret anormali.
English: Symptoms of overdose are not established.
Maltese: Is-sintomi ta' doża eċċessiva mhumiex determinati.
English: No dose adjustment is required for patients with mild hepatic impairment (total bilirubin ≤ 1 × upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għal pazjenti b'indeboliment tal-fwied ħafif (bilirubina totali ≤1 × limitu ta' fuq tan-normal [ULN, upper limit of normal] u aspartataminotransferażi (AST)
English: Following oral administration of a single 1 mg dose of [14C]talazoparib to humans, no major circulating metabolites were identified in plasma, and talazoparib was the only circulating drug-derived entity identified.
Maltese: C]talazoparib lill-bnedmin, ma ġie identifikat l-ebda metabolit ċirkolatorju filplażma, u talazoparib kien l-unika entità derivata mill-mediċina ċirkolatorja li ġiet identifikata.
English: APPROPRIATE
Maltese: Asjatiċi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/001 (30 hard capsules)
Maltese: EU/1/19/1377/001 (30 kapsula iebsa)
English: b. Includes preferred terms of anaemia, haematocrit decreased and haemoglobin decreased.
Maltese: Tinkludi termini ppreferuti ta' anemija, tnaqqis fl-ematokrit u tnaqqis fl-emoglobina.
English: The effect of talazoparib on cardiac repolarisation was evaluated using time-matched electrocardiograms (ECGs) in assessing the relationship between the change of the QT interval corrected for heart rate (QTc) from baseline and the corresponding plasma talazoparib concentrations in 37 patients with advanced solid tumours.
Maltese: L-effett ta' talazoparib fuq ir-ripolarizzazzjoni kardijaka ġie evalwat permezz ta' elettrokardjogrammi (ECGs) mqabbla mal-ħin fil-valutazzjoni tar-relazzjoni bejn il-bidla tal-intervall QT ikkoreġut għarrata tal-qalb (QTc) mil-linja bażi u l-konċentrazzjonijiet korrispondenti ta' talazoparib fil-plażma f'37 pazjent b'tumuri solidi avvanzati.
English: Talazoparib
Maltese: NUMRU TAL-LOTT
English: Abdominal painf
Maltese: TAGĦRIF
English: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).
Maltese: 30 mm x 5.32 mm b'kappa ħamra ċara (stampata b'“Pfizer” bliswed) u b'korp abjad (stampat b'“TLZ 1” bl-iswed).
English: 90 × 1 capsules
Maltese: Tiftaħx il-kapsuli.
English: Missing
Maltese: Disgewżja
English: Talzenna has not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or patients requiring haemodialysis.
Maltese: Talzenna ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi sever (CrCl < 30 mL/min) jew pazjenti li jeħtieġu emodijalisi.
English: Developmental toxicology
Maltese: IL-PRODOTT MEDIĊINALI
English: BCRP inhibitors
Maltese: Inibituri ta' BRCP
English: Renal elimination of unchanged drug (passive filtration and active secretion) is the major route of talazoparib elimination.
Maltese: L-eliminazzjoni mill-kliewi tal-mediċina mhux mibdula (filtrazzjoni passiva u sekrezzjoni attiva) hija r-rotta ewlenija tal-eliminazzjoni ta' talazoparib.
English: If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced (see section 4.2).
Maltese: Jekk l-għoti flimkien ma' inibitur qawwi ta' P-gp ma jistax jiġi evitat, id-doża ta' Talzenna għandha titnaqqas (ara sezzjoni 4.2).
English: Talazoparib Chemotherapy
Maltese: L-istatus tal-mutazzjoni
English: Ammonium hydroxide (E527)
Maltese: Propylene glycol (E1520) Ammonium hydroxide (E527) Black iron oxide (E172) Potassium hydroxide (E525)
English: Female
Maltese: Kurvi
English: The complete response rate was 5.5% for talazoparib compared to 0% for the chemotherapy arm. e. Per RECIST 1.1, confirmation of CR/PR was not required.
Maltese: Ir-rata ta' rispons sħiħ kienet 5.5% għal talazoparib meta mqabbel ma' 0% għall-fergħa tal-kimoterapija.
English: The Kaplan-Meier curves for PFS is displayed in Figure 1.
Maltese: Il-kurvi ta' Kaplan Meier għal PFS huma murija f'Figura 1.
English: PARP inhibitors (PARPi) exert cytotoxic effects on cancer cells by 2 mechanisms, inhibition of PARP catalytic activity and by PARP trapping, whereby PARP protein bound to a PARPi does not readily dissociate from a DNA lesion, thus preventing DNA repair, replication, and transcription, thereby resulting in apoptosis and/or cell death.
Maltese: L-inibituri ta' PARP (PARPi) jeżerċitaw effetti ċitotossiċi fuq iċ-ċelluli talkanċer permezz ta' żewġ mekkaniżmi, inibizzjoni ta' attività katalitika ta' PARP u permezz ta' qbid ta' PARP, fejn proteina PARP marbuta ma' PARPi ma tiddisassoċjax faċilment minn leżjoni ta' DNA, b'hekk tipprevjeni tiwsija replikazzjoni u traskrizzjoni, li b'hekk tirriżulta f'apoptożi u/jew mewt taċċelluli.
English: Insufficient data are available to estimate the impact of severe renal impairment on talazoparib CL/F in this patient population.
Maltese: M'hemmx biżżejjed data disponibbli biex jiġi stmat l-impatt ta' indeboliment tal-kliewi sever tas-CL/F ta' talazoparib f'din il-popolazzjoni tal-pazjent.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Talzenna 0.25 mg hard capsules
Maltese: 0.25 mg qoxra tal-kapsula
English: h. Includes preferred terms of fatigue and asthenia.
Maltese: Tinkludi termini ppreferuti ta' għeja u astenija.
English: Myelosuppression-related adverse events associated with dose modifications were reported for up to approximately 30% of patients in the talazoparib 1 mg/day population and those associated with permanent study drug discontinuation were reported for less than 1% of patients.
Maltese: Avvenimenti avversi relatati malmajelosoppressjoni assoċjati ma' modifikazzjonijiet fid-doża ġew irrappurtati għal sa madwar 30% tal-pazjenti fil-popolazzjoni ta' talazoparib 1 mg/jum u dawk assoċjati ma' twaqqif permanenti talmediċina tal-istudju ġew irrappurtati għal inqas minn 1% tal-pazjenti.
English: Carbamazepine and phenytoin - anti-epileptics used to treat seizures or fits.
Maltese: Il-mediċini li ġejjin jistgħu jnaqqsu l-effett ta' Talzenna: - Carbamazepine and phenytoin - anti-epilettiċi li jintużaw biex jiġu kkurati aċċessjonijiet jew puplesiji.
English: Precautions should be taken to routinely monitor haematology parameters and signs and symptoms associated with anaemia, leucopenia/neutropenia, and/or thrombocytopenia in patients receiving talazoparib.
Maltese: Għandhom jittieħdu prekawzjonijiet biex jiġu mmonitorjati b'mod frekwenti l-parametri talematoloġija u sinjali u sintomi assoċjati ma' anemija, lewkopenja/newtropenja, u/jew tromboċitopenja f'pazjenti li jirċievu talazoparib.
English: Renal impairment
Maltese: Komuni ħafna Rimettar
English: Titanium dioxide (E171)
Maltese: Hypromellose (HPMC) Yellow iron Oxide (E172) Titanium dioxide (E171)
English: Age, sex, and body weight
Maltese: Età, sess u piż tal-ġisem
English: Itraconazole and ketoconazole - used to treat fungal infections.
Maltese: - Itraconazole u ketoconazole - li jintużaw biex jikkuraw infezzjonijiet fungali.
English: Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Maltese: Talzenna huwa indikat bħala monoterapija għall-kura ta' pazjenti adulti b'mutazzjonijiet BRCA1/2 tal-linja ġerminali, li għandhom kanċer tas-sider lokalment avvanzat jew metastatiku negattiv għallHER2.
English: The median accumulation ratio of talazoparib following repeated oral administration of 1 mg once daily was in the range of 2.3 to 5.2.
Maltese: Il-proporzjon ta' akkumulazzjoni medjan ta' talazoparib wara għoti orali ripetut ta' 1 mg darba kuljum kien fil-medda ta' 2.3 sa 5
English: HER2-positive
Maltese: Pożittiv għall-HER2
English: Fatigueh
Maltese: Il-Belġju
English: Patients with prior platinum therapy for advanced disease were required to have no evidence of disease progression during platinum therapy.
Maltese: Il-pazjenti b'terapija preċedenti bil-platinu għal marda avvanzata kienu meħtieġa li ma jkollhom l-ebda evidenza ta' progressjoni tal-marda waqt terapija bil-platinu.
English: In 6 female patients given a single oral dose of [14C]talazoparib, a mean of 69% (±8.6%) and 20%
Maltese: F'6 pazjenti nisa li ngħataw doża orali waħda ta' C]talazoparib, ġiet irkuprata medja ta' 69% (±8.6%) u 20% (±5.5%) tad-doża radjuattiva mogħtija totali fl-awrina u fl-ippurgar, rispettivament.
English: Hazard Ratio=0.54 95% CI (0.41, 0.71) p<0.0001
Maltese: valur p b'żewġ naħat p<0.0001
English: BRCA mutation status (breast cancer susceptibility gene 1 [BRCA1] positive or breast cancer susceptibility gene 2 [BRCA2] positive) was similar across both treatment arms.
Maltese: BRCA (pożittiv għal ġene ta' suxxettibbiltà għal kanċer tas-sider 1 [BRCA1] jew pożittiv għal ġene ta' suxxettibbiltà għal kanċer tas-sider 2 [BRCA2]) kien simili fiż-żewġ fergħat ta' kura.
English: The median duration of exposure was 5.4 months (range 0.03-61.1).
Maltese: Id-durata medjana tal-esponiment kienet 5.4 xhur (medda ta' 0.
English: Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micronucleus assay in rats but not mutagenic in Ames assay (see section 5.3), and may cause foetal harm when administered to a pregnant woman.
Maltese: Talazoparib kien klastoġeniku f'assaġġ ta' aberrazzjoni kromożomali in vitro f'limfoċiti tad-demm periferali tal-bniedem u f'assaġġ tal-mikronukleu tal-mudullun in vivo fil-firien iżda mhux mutaġeniku fl-assaġġ Ames (ara sezzjoni 5.3), u jista' jikkawża ħsara lill-fetu meta jingħata lil mara tqila.
English: United Kingdom SoliCol D3
Maltese: SoliCol D3
English: TABLET
Maltese: PILLOLA
English: Unipessoal, Lda.
Maltese: Farmacêuticos, Sociedade Unipessoal, Lda.
English: Annex IC - SoliCol D3 Member State in EU/EEA
Maltese: Anness IC - SoliCol D3 Stat Membru flUE/ŻEE
English: Member State in EU/EEA
Maltese: UE/ŻEE
English: COLECALCIFEROL 20,000 IU
Maltese: COLECALCIFEROL 20,000
English: COLECALCIFEROL 50,000 IU
Maltese: COLECALCIFEROL 50,000
English: United Kingdom Dutasteride Actavis Group
Maltese: Dutasteride Actavis Group
English: Pharmaceutica l form
Maltese: Anness I
English: Ferring Hellas Mepe Progesterone
Maltese: Ferring Hellas Mepe
English: Ferring Lægemidler A/S
Maltese: Ferring Lægemidler A/S Progesterone
English: Ferring Magyarország Gyógyszerkereskedel mi Kft.
Maltese: Ferring Magyarország Gyógyszerkereskedelmi
English: Annex I List of nationally authorised medicinal products
Maltese: Lista ta' prodotti mediċinali awtorizzati nazzjonalment
English: Annex IA - Lutinus and associated names Member State in
Maltese: Anness IA - Lutinus u ismijiet assoċjati Stat Membru fl
English: Annex IB - Dutasteride Actavis and associated names Member State in
Maltese: Anness IB - Dutasteride Actavis u ismijiet assoċjati Stat Membru fl
English: United Kingdom Lutigest
Maltese: Ir-Repubblika Ċeka Lutinus
English: ORAL USE
Maltese: UŻU ORALI
English: 5 February 2016
Maltese: 9 Frar 2016
English: EMA/736031/2014, Rev. 1 Information Management
Maltese: EMA/737125/2014, Rev.
English: Legal Requirements
Maltese: Rekwiżiti Legali
English: Article 57 (2) of Regulation (EC) No 726/2004
Maltese: Artikolu 57 (2) tar-Regolament (KE) Nru 726/2004
English: Enquiries related to Article 57(2) submissions can be submitted to the EMA via the EMA Service Desk portal (https://servicedesk.ema.europa.eu).
Maltese: Mistoqsijiet dwar sottomissjonijiet magħmula taħt l-Artikolu 57(2) jistgħu jintbagħtu lill-EMA permezz tal-EMA Service Desk portal (https://servicedesk.ema.europa.eu).
English: Useful sources of information
Maltese: 1 Information Management
English: • centrally authorised medicinal products;
Maltese: • prodotti mediċinali awtorizzati ċentralment;
English: What to submit: Information on medicinal products
Maltese: Informazzjoni dwar prodotti mediċinali
English: The submission of medicinal product data by marketing-authorisation holders (MAHs) is a legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004.
Maltese: Is-sottomissjoni ta' data ta' prodotti mediċinali mid-detenturi tal-awtorizzazzjonijiet għat-tqegħid fissuq (MAHs) hija rekwiżit legali introdott mill-Artikolu 57(2) tar-Regolament (KE) Nru 726/2004.
English: Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal shall be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised as per guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Maltese: Informazzjoni dwar kwalunkwe emenda għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq wara varjazzjoni, trasferiment, tiġdid, sospensjoni, revoka jew irtirar għandha tintbagħat lill-EMA mhux aktar tard minn 30 jum kalendarju mid-data li fiha l-emendi jkunu ġew awtorizzati skont il-gwida u lproċessi deskritti f'Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
English: • coding of substance and product information reported in Individual Case Safety Reports (ICSRs) within the Eudravigilance system to support Pharmacovigilance signal management activities and the performance of data analysis and business intelligence at the Agency;
Maltese: • il-kodifikazzjoni ta' informazzjoni dwar sustanzi u prodotti rrappurtati f'Rapporti Dwar is-Sikurezza ta' Każijiet Individwali (ICSRs - Individual Case Safety Reports) fis-sistema tal-Eudravigilance biex tappoġġa attivitajiet ta' maniġġar ta' sinjali ta' farmakoviġilanza u analiżi ta' data u ta' intelliġenza dwar il-qasam ta' ħidma fl-Aġenzija;
English: This information will be used to support regulatory business activities, including:
Maltese: Din l-informazzjoni sejra tintuża biex tappoġġja attivitajiet regolatorji, inklużi:
English: Why submit: Scope
Maltese: L-iskop
English: By 31 December 2014 MAHs were also required to improve quality of information on authorised medicines submitted to the EMA, bring their medicinal product entries up-to-date and submit additional information in line with the guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Maltese: Sal-31 ta' Diċembru 2014 id-detenturi kienu wkoll meħtieġa jtejbu l-kwalità tal-informazzjoni dwar mediċini awtorizzati sottomessi lill-EMA, jaġġornaw l-entrati tal-prodotti mediċinali u jissottomettu informazzjoni addizzjonali b'mod konformi mal-gwidi u l-proċessi deskritti f'Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
English: For enquires on how to register contact the Eudravigilance registration office (eudravigilanceregistration@ema.europa.eu).
Maltese: Għal mistoqsijiet fuq kif tirreġistra, ikkuntattja lill-uffiċċju tar-reġistrazzjonijiet tal-Eudravigilance (eudravigilanceregistration@ema.europa.eu).
English: This is to ensure that privacy and security measures are in place and that the principles of integrity, accountability and availability of data are adhered to.
Maltese: Dan biex jiġi żgurat li l-miżuri ta' privatezza u sigurtà jkunu fis-seħħ u biex ikun hemm konformità mal-prinċipji ta' integrità, kontabilità u disponibbiltà tad-data.
English: Since July 2012, MAHs are required to submit information on new marketing authorisations granted after 2 July 2012 within 15 calendar days from the date of notification of the granting of the marketing authorisation by the NCA.
Maltese: Minn Lulju 2012, id-detenturi huma meħtieġa jissottomettu informazzjoni dwar awtorizzazzjonijiet għat-tqegħid fis-suq ġodda mogħtija wara t-2 ta' Lulju 2012 fi żmien 15-il jum kalendarju mid-data ta' notifikazzjoni tal-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq mill-NCA.
English: For information related to submission of authorised medicines data visit the Data submission webpage.
Maltese: Għal informazzjoni relatata mas-sottomissjoni ta' data għal mediċini awtorizzati żur il-paġna web ta' sottomissjoni tad-data.
English: • medicinal products authorised through the decentralised procedure.
Maltese: • prodotti mediċinali awtorizzati permezz tal-proċedura deċentralizzata.
English: For documents related to submission of authorised medicines data visit the Guidance document webpage.
Maltese: Għal dokumenti relatati ma' sottomissjoni ta' data għal mediċini awtorizzati żur il-paġna web ta' gwida tad-dokument.
English: This legal provision requires all holders of marketing authorisations for medicinal products for human use in the European Economic Area (EEA) to submit information to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format.
Maltese: Din id-dispożizzjoni legali teħtieġ li d-detenturi kollha tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali għall-użu tal-bniedem fiż-Żona Ekonomika Ewropea (EEA) jissottomettu informazzjoni lil-Aġenzija Ewropea dwar il-Mediċini (EMA) bl-użu tal-format elettroniku li ssir referenza għalih bħala l-format tal-Artikolu 57 jew format tal-Messaġġ Estiż tar-Rapport dwar il-Prodott talEudravigilance (XEVPRM).