FrancophonIA/ELRC3.0 huggingface dataset:
English: It has also been shown that fulvestrant 500 mg downregulates ER and the proliferation marker Ki67, to a greater degree than fulvestrant 250 mg in breast tumours in postmenopausal neoadjuvant setting.
Maltese: Intwera wkoll li fulvestrant 500 mg inaqqas (downregulates) ir-riċettur tal-proteina ER u l-markatur tal-proliferazzjoni Ki67, aktar minn fulvestrant 250 mg f'tumuri tas-sider f'kura miżjuda fil-bidu f'nisa ta' wara l-menopawża.
English: NOTE: Activate away from self and others.
Maltese: NOTA: Attiva 'il bogħod minnek u minn oħrajn.
English: A total of 17.1% of patients received a prior chemotherapy regimen for advanced disease; 84.2% of patients had measurable disease.
Maltese: Total ta' 17.1 % tal-pazjenti rċivew reġimen ta' kimoterapija preċedenti għal marda avvanzata; 84.2 % kellhom marda li tista' titkejjel.
English: Environmental Risk Assessment (ERA)
Maltese: Stima tar-Riskju Ambjentali (ERA, Environmental Risk Assessment)
English: • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
Maltese: • Reazzjonijiet allerġiċi (sensittività eċċessiva), inkluż nefħa tal-wiċċ, tax-xofftejn, tal-ilsien u/jew tal-griżmejn li jistgħu jkunu sinjali ta' reazzjonijiet anafilattiċi
English: Combined analysis of both studies showed that 83% of patients who received Faslodex progressed, compared with 85% of patients who received anastrozole.
Maltese: mqabbel ma' 85% tal-pazjenti li rċivew anastrozole.
English: , hepatitis f, elevated gamma-GT
Maltese: , epatite f,
English: A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to Faslodex plus palbociclib or Faslodex plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Maltese: Total ta' 521 mara ta' qabel/waqt il-menopawża u li għaddew mill-menopawża li kienu għamlu progress fuq jew fi żmien 12-il xahar mit-tlestija tat-terpija endokrinali aġġuvanti jew fuq jew fi żmien xahar minn terapija endokrinali minn qabel għall-marda avvanzata, ġew randomizzati 2:1 għal Faslodex flimkien ma' palbociclib jew Faslodex flimkien mal-plaċebo u ġew stratifikati permezz ta' sensittività dokumentata għal terapija ormonali minn qabel, status tal-menopawża meta daħlu fl-istudju (qabel/waqt il-menopawża kontral li għaddew mill-menopawża), u lpreżenza ta' metastasi vixxerali.
English: A Phase 3, randomised, double-blind, double-dummy, multicentre study of Faslodex 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Maltese: Sar studju studju ta' Fażi 3, randomizzat, double-blind, double-dummy, multiċentriku ta' Faslodex 500 mg kontra anastrozole 1 mg fin-nisa li kienu għaddew mill-menopawża b'kanċer tas-sider pożittiv għal ER u/jew pożittiv għal PgR lokalment avvanzat jew metastatiku li ma ġewx ikkurati preċedentement b'xi terapija bl-ormoni.
English: When Faslodex is combined with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Maltese: Meta Faslodex ħa jiġi kkombinat ma' palbociclib, jekk jogħġbok irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott ta' palbociclib.
English: The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2).
Maltese: Ilkonċentrazzjonijiet minimi ta' stat fiss ta' fulvestrant fit-tfal f'dan l-istudju kienu konsistenti ma dawk fl-adulti (ara sezzjoni 5.2).
English: These occurred at exposure levels higher than in patients (Cmax >15 times) and are likely to be of limited significance for human safety at the clinical dose.
Maltese: (Cmax>15 il-darba) u huma probabbli li jkunu ta' sinifikat limitat għas-sigurtà tal-bniedem fiddoża klinika.
English: These studies compared the safety and efficacy of monthly administration of Faslodex 250 mg versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
Maltese: Dawn l-istudji qabblu s-sigurtà u l-effikaċja talamministrazzjoni ta' 250 mg Faslodex kull xahar ma' anastrozole, (inibittur ta' aromatase) b'doża ta' 1 mg kuljum.
English: In patients receiving fulvestrant in combination with palbociclib, the median time to first episode of any grade neutropenia was 15 days (range: 13-317) and the median duration of Grade ≥3 neutropenia was 7 days.
Maltese: F'pazjenti li kienu qed jiriċevu fulvestrant flimkien ma' palbociclib, iż-żmien medjan għallewwel episodju ta' newtropenja ta' kwalunkwe grad kien ta' 15-il jum (medda: 13-317) u ddurata medjana ta' newtropenja ta' Grad ≥3 kienet ta' 7 ijiem.
English: The overall safety profile of fulvestrant when used in combination with palbociclib is based on data from 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer in the randomised PALOMA3 study (see section 5.1).
Maltese: Il-profil tas-sigurtà globali ta' fulvestrant meta jintuża flimkien ma' palbociclib huwa bbażat fuq dejta minn 517-il pazjent b'kanċer tas-sider pożittiv għall-HR, negattiv għall-HER avvanzat jew metastatiku fl-istudju randomizzat PALOMA3 (ara sezzjoni 5.1).
English: Table 6 Efficacy results in visceral and non-visceral disease from PALOMA3 study (intentto-treat population)
Maltese: Tabella 6 Riżultati tal-effikaċja f'mard vixxerali u mhux vixxerali fl-istudju PALOMA3 (popolazzjoni bl-intenzjoni li tiġi kkurata)
English: Key secondary efficacy endpoints included overall survival (OS) and objective response rate (ORR).
Maltese: Punti tat-tmiem sekondarji importanti dwar l-effikaċja kienu jinkludu ssopravivenza totali (OS) u r-rata oġġettiva tar-rispons (ORR).
English: Joint and musculoskeletal pain
Maltese: Uġigħ fil-ġogi u fil-muskoluskeletriċi
English: Patients enrolled in this study had a median age of 63 years (range 36-90).
Maltese: Il-pazjenti li rreġistraw f'dan l-istudju kellhom età medjana ta' 63 sena (firxa 36-90).
English: A 2-week study in healthy postmenopausal volunteers treated with 20 μg per day ethinylestradiol showed that pretreatment with Faslodex 250 mg resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness.
Maltese: .3) Studju ta' ġimagħtejn li sar fuq voluntiera b'saħħithom, ikkurati b'20 ug ethinylestradiol kuljum wera li kura minn qabel b'doża ta' 250 mg Faslodex, irriżultat f'effett ta' nuqqas sinifikanti ta' stimulu tal-endometriju postmenopawżali, meta mqabbel ma' oħrajn li ħadu plaċebo kif deher mill-ultrasound li kejjel il-ħxuna tal-endometriju.
English: • Thromboembolism (increased risk of blood clots)*
Maltese: • Tromboemboliżmu (riskju akbar ta' ffurmar ta' emboli tad-demm)
English: There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: M'hemm l-ebda dejta fuq pazjenti b'indeboliment serju tal-fwied (ara ssezzjonijiet 4.3, 4.4 u 5.2).
English: • Vaginal bleeding
Maltese: • Uġigħ fid-dahar
English: Faslodex should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Maltese: Is-sigurta u l-effikaċja ma ġewx evalwati f'pazjenti b'indeboliment serju tal-kliewi (livell ta' tneħħija ta' kreatinina < 30 ml/min).
English: Hot flushes
Maltese: Mard Vixxerali
English: In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Maltese: Fin-nisa ta' qabel jew ta' waqt il-menopawża, il-kura ta' kombinazzjoni b'palbociclib għandha tiġi kkombinata ma' agonista ta' ormon li jistimula l-produzzjoni tal-ormon ta' lutenizazzjoni (LHRH, luteinizing hormone releasing hormone).
English: - The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
Maltese: Is-sustanzi l-oħra (eċċipjenti) huma ethanol (96 fil-mija), benzyl alcohol, benzyl benzoate u castor oil raffinat.
English: Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with Faslodex injection.
Maltese: Bl-injezzjoni ta' Faslodex ġew irrappurtati episodji relatati mas-sit tal-injezzjoni inklużi xjatika, newralġija, uġigħ newropatiku, u newropatija periferali.
English: Of the 65 patients in the Faslodex arm, 40% (26/65) of patients reported joint and musculoskeletal pain within the first month of treatment, and 66.2% (43/65) of patients within the first 3 months of treatment.
Maltese: Mill-65 pazjent fil-fergħa ta' Faslodex, 40 % (26/65) tal-pazjenti rrappurtaw uġigħ fil-ġogi u uġigħ muskolu-skeletriku fl-ewwel xahar tal-kura, u 66.2 % (43/65) tal-pazjenti flewwel 3 xhur tal-kura.
English: In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
Maltese: Fis-sett tad-dejta miġbur ta' monoterapija ta' fulvestrant, ir-reazzjonijiet avversi irrapportati l-aktar frekwenti kienu reazzjonijiet fis-sit talinjezzjoni, astenja, dardir u żieda fl-enżimi epatiċi (ALT, AST, ALP).
English: Instructions for administration
Maltese: MANIFATTUR RESPONSABBLI
English: • Decreased levels of platelets (thrombocytopenia)
Maltese: • Tnaqqis fil-livell ta' plejtlits (tromboċitopenja)
English: Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Maltese: Fulvestrant huwa antagonista kompetittiv tar-riċettur tal-estroġenu u jeħel mar-riċetturi talestroġenu b'affinità li komparabbli ma' dik ta' estradiol.
English: PFS Median [months (95% CI)] Number of OS Events* OS Hazard Ratio (95% CI) and p-value
Maltese: PFS Medjana [xhur (95 % CI)] Numru ta' Avvenimenti
English: The pre-filled syringe presentation consists of:
Maltese: RMP aġġornat għandu jiġi ppreżentat:
English: All Grades n (%)
Maltese: Il-Gradi Kollha n (%)
English: In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Maltese: Fil-firien, ġie osservat tnaqqis riversibbli fil-fertilità fis-sess femminili u fis-sopravivenza embrijonika, distoċja u inċidenza ogħla ta' anomalitajiet tal-fetu inkluż tagħwiġ fit-tarsu.
English: • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat
Maltese: • Reazzjonijiet allerġiċi (sensittività eċċessiva), li jinkludu nefħa tal-wiċċ, xofftejn, ilsien u/jew griżmejn
English: • Headache
Maltese: Cheshire
English: Fertility The effects of Faslodex on fertility in humans has not been studied.
Maltese: Fertilità L-effetti ta' Faslodex fuq il-fertilità fin-nies ma ġewx studjati.
English: One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
Maltese: Siringa mimlija għal-lest b'250 mg fulvestrant f'soluzzjoni ta' 5 ml.
English: Injection site haemorrhage f, injection site haematoma f, neuralgia c,f
Maltese: ematoma fis-sit tal-injezzjoni f,
English: Neuropathy peripheral e, sciatica
Maltese: Reazzjoni fis-sit tal-injezzjoni Newroptaija periferali e,xjatika
English: The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
Maltese: It-terminu reazzjoni fil-post tal-injezzjoni ma jinkludix it-termini emorraġija fil-post talinjezzjoni, ematoma fil-post tal-injezzjoni, xjatika, nevralġija u newropatija periferali.
English: The role of sex hormone-binding globulin (SHBG) has not been determined.
Maltese: L-irwol tal-globulina li teħel mal-ormoni sesswali (SHBG) għadu ma ġiex determinat.
English: PRE-FILLED SYRINGE LABEL
Maltese: Il-pazjenti kollha
English: A two-year oncogenicity study in rats (intramuscular administration of Faslodex) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
Maltese: Studju tal-onkoġeniċità ta' sentejn fil-firien, (Faslodex mogħti ġol-muskolu) wera żieda flinċidenza ta' tumuri beninni taċ-ċelluli granulożi tal-ovarji fil-firien nisa bid-doża l-għolja, 10 mg/far/15-il ġurnata u żdiedet ukoll l-inċidenza ta' tumuri testikulari taċ-ċelluli Leydig filfirien irġiel.
English: • Joint and musculoskeletal pain
Maltese: • Uġigħ fil-ġogi u fil-muskolu-skeletriċi
English: A reduction in the risk of disease progression or death in the Faslodex plus palbociclib arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
Maltese: Ġie osservat tnaqqis fir-riskju tal-progressjoni tal-marda jew mewt fil-fergħa ta' Faslodex u palbociclib fis-sottogruppi tal-pazjenti individwali kollha definit permezz ta' fatturi ta' stratifikazzjoni u karatteristiċi tal-linja bażi.
English: Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
Maltese: Minħabba l-mod ta' kif jaħdem fulvestrant hemm riskju potenzjali ta' osteoporożi.
English: • Increase of gamma-GT, a liver enzyme seen in a blood test
Maltese: • Żieda tal-gamma-GT, enzima tal-fwied li tidher f'test tad-demm
English: The median duration of fulvestrant 500 mg treatment across the pooled dataset (including the studies mentioned above plus FALCON) was 6.5 months.
Maltese: Id-durata medjana ta' kura b'fulvestrant 500 mg fost is-sett tad-dejta miġbur (inkluż l-istudji msemmija hawn fuq flimkien ma' FALCON) kienet ta' 6.5 xhur.
English: Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity.
Maltese: Jinkludu: artralġja, u uġigħ muskolu-skelettriku inqas frekwenti, majalġja u uġigħ f'estremità.
English: The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the pre-specified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Maltese: L-istudju ssodisfa l-end-point primarju tiegħu li jtawwal il-PFS ivvalutata mill-investigatur flanaliżi interim li saret fuq 82% tal-avvenimenti ppjanati ta' PFS; ir-riżultati għaddew il-konfini tal-effikaċja ta' Haybittle-Peto speċifikat minn qabel (α=0.00135), li wrew titwil statistikament sinifikanti fil-PFS u effett ta' kura klinikament sinifikanti.
English: Fulvestrant is subject to extensive and rapid distribution.
Maltese: Fulvestrant huwa soġġett għal distrubuzzjoni estensiva u ta' malajr.
English: The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant.
Maltese: Il-pazjenti pedjatriċi kellhom bejn 1 sa 8 snin u rċivew doża ta' 4 mg/kg fil-muskolu fix-xahar ta'
English: The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/kg suggests that distribution is largely extravascular.
Maltese: Il-volum kbir apparenti ta' distribuzzjoni fi stat fiss (Vdss) huwa bejn wieħed u ieħor minn 3 sa 5 l/kg, li jissuġġerixxi li ddistribuzzjoni komposta tas-sustanza hija fil-parti l-kbira tagħha ekstra-vaskulari.
English: Urinary tract infections
Maltese: IL-PRODOTT MEDIĊINALI
English: Addition of palbociclib to Faslodex resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with Faslodex plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Maltese: Żieda ta' palbociclib għal Faslodex irriżultat f'benefiċċju tas-sintomi billi ż-Żmien għad-Deterjorazzjoni ġie ttardjat b'mod sinifikanti fis-sintomi tal-uġigħ meta mqabbel ma' Faslodex u l-plaċebo (medjan 8.0 xhur kontra 2.8 xhur;
English: There were no reports of Grade 4 neutropenia in the fulvestrant + placebo arm.
Maltese: Ma kien hemm l-ebda rapport ta' newtropenja ta' Grad 4 fil-fergħa ta' fulvestrant + plaċebo.
English: The results in the AI subgroup are inconclusive.
Maltese: Ir-riżultati fis-sotto grupp A1 mhumiex konklussivi.
English: • Abnormal levels of liver enzymes (in blood tests)*
Maltese: • Livelli anormali tal-enzimi tal-fwied (fit-testijiet tad-demm)
English: There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae).
Maltese: Kien hemm żieda fl-inċidenza ta' varjazzjonijiet fetali fil-fniek (iċ-ċintura pelvika u s-27 vertebra presakrali resqu lura).
English: Studies using human liver preparations and recombinant human enzymes indicate that CYP3A4 is the only P450 isoenzyme involved in the oxidation of fulvestrant; however, non-P450 routes appear to be more predominant in vivo.
Maltese: Studji fejn intużaw preparazzjonijiet tal-fwied tal-bniedem u enżimi umani rikombinanti jindikaw li CYP3A4 huwa l-uniku isoeżima P450 involuta fl-ossidità ta' fulvestrant, madankollu, in vivo, rotot ta' mhux P450 jidhru li huma iktar dominanti.
English: Fulvestrant showed no genotoxic potential.
Maltese: Fulvestrant ma wera l-ebda potenzjal ġenotossiku.
English: AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
Maltese: AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
English: N=number of patients; CI=confidence interval; OR= objective response; TTR=time to first tumour response.
Maltese: N=numru ta' pazjenti; CI=intervall ta' fiduċja; OR= rispons oġġettiv;
English: Updated Analysis (23 October 2015 cut-off) Faslodex plus palbociclib (N=347)
Maltese: Analiżi Aġġornata (cut-off tat-23 ta' Ottubru 2015)
English: There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Maltese: Ma hemm l-ebda evidenza tal-effetti endometrijali avversi fil-pazjenti b'kanċer tas-sider li ġew studjati.
English: Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Maltese: In-newtropenja tinkludi l-PTs li ġejjin:
English: Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and p-value
Maltese: Proporzjon ta' Periklu PFS (95 % CI) u valur-p
English: Arteritis involving a range of different tissues was seen in some dogs after chronic (12 months) dosing.
Maltese: Artrite li tinvolvi firxa ta' tessuti differenti dehret f'xi klieb wara dożaġġ kroniku (12-il xahar).
English: NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Faslodex at the dorsogluteal injection site (see section 4.4).
Maltese: NOTA: Minħabba l-prossimità tan-nerv xjatiku sottostanti, għandha tingħata kawtela jekk Fasoldex jingħata fit-sit tal-injezzjoni dorsoglutejali (ara s-sezzjoni 4.4).
English: Variable
Maltese: Varjabli
English: Combined analysis of both studies showed the hazard ratio of Faslodex 250 mg to anastrozole for progression-free survival was 0.95 (95% CI 0.82 to 1.10).
Maltese: L-analiżi meħudin f'daqqa taż-żewġ studji wrew li l-proporzjon ta' riskju ta' Faslodex 250 mg u anastrozole għal sopravivenza mingħajr ilmarda kien ta' 0.95 (95% CI 0.
English: Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Maltese: It-tromboċitopenia tinkludi l-PTs li ġejjin: Tromboċitopenia, Għadd imnaqqas tal-plejtlits.
English: No interaction studies were conducted on competitive protein binding.
Maltese: Għalhekk ma sar l-ebda studju dwar l-interazzjoni tal-mediċina meta tingħaqad mal-proteina b'mod kompetittiv.
English: Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in serum bone-turnover markers.
Maltese: Kura miżjuda fil-bidu sa 16-il ġimgħa f'pazjenti bil-kanċer tas-sider b'jew Faslodex 500 mg jew Faslodex 250 mg ma rriżultax f'tibdil klinikament sinifikanti tal-markaturi għat-tibdil fl-għadam, fis-serum.
English: Two Phase 3 clinical studies were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Maltese: Saru żewġ studji kliniċi ta' Fażi 3 fuq total ta' 851 mara li għaddew mill-menopawża u li kellhom kanċer tas-sider fi stat avvanzat u li reġgħet qabdithom il-marda waqt jew wara t-terapija endrokinali miżjuda jew li l-marda tagħhom aggravat wara t-terapija endokrinali għal marda avvanzata.
English: Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Maltese: Interferenza ma' assaġġi ta' antikorpi ta' estradiol Minħabba s-similarità strutturali ta' fulvestrant u estradiol, fulvestrant jista' jinterferixxi ma' assaġġi ta' estradiol ibbażati fuq l-antikorpi u dan jista' jwassal għal livelli miżjuda b'mod falz ta' estradiol.
English: Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect.
Maltese: Kura miżjuda fil-bidu sa 16-il ġimgħa f'pazjenti bil-kanċer tas-sider ikkurati jew b'Faslodex 500 mg jew b'Faslodex 250 mg ma rriżultax f'tibdil klinikament sinifikanti fil-ħxuna endometrijali, u dan jindika nuqqas ta' effett agonsta.
English: The descriptions included below are based on the safety analysis set of 228 patients who received at least one (1) dose of fulvestrant and 232 patients who received at least one (1) dose of anastrozole, respectively in the Phase 3 FALCON study.
Maltese: Id-deskrizzjonijiet inklużi hawn taħt huma bbażati fuq is-sett ta' analiżi tas-sigurtà ta' 228 pazjent li rċivew tal-inqas doża waħda (1) ta' fulvestrant u 232 pazjent li rċivew tal-inqas doża waħda (1) ta' anastrozole, rispettivament fl-istudju FALCON ta' Fażi 3.
English: d.) Project 2014
Maltese: d.) Proġett 2014
English: Representative of veterinarians' organisations Observers
Maltese: Rappreżentant ta' organizzazzjonijiet veterinarji Osservaturi
English: Session 3:
Maltese: Sessjoni 3:
English: Session 2:
Maltese: Sessjoni 2:
English: Viola Macolić Šarinić (Croatia)
Maltese: Viola Macolić Šarinić (il-Kroazja)
English: Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Gro Wesenberg (Norway)
Maltese: Rannveig Gunnarsdóttir (l-Islanda) Brigitte Batliner (il-Liechtenstein) Gro Wesenberg (in-Norveġja)
English: Bilateral with the FDA
Maltese: Bilaterali mal-FDA
English: Andreas Pott Patrick Le Courtois David Mackay Luc Verhelst Noël Wathion Martin Harvey Allchurch Emer Cooke Tomasz Jablonski Michael Lenihan Isabelle Moulon Frances Nuttall Zuzana O'Callaghan Nerimantas Steikūnas
Maltese: Andreas Pott Patrick Le Courtois David Mackay Luc Verhelst Noël Wathion Martin Harvey Allchurch Emer Cooke Tomasz Jablonski Michael Lenihan Isabelle Moulon Frances Nuttall Zuzana
English: The budget for 2013 is €239.1 million (2012: € 222.5 million), of which the forecast fee revenue is €181.9 million.
Maltese: Il-baġit għall-2013 huwa ta' €239.1 miljun (2012: € 222.5 miljun), li għalih, id-dħul imbassar mit-tariffi huwa ta' €181.9 miljun.
English: • The renewed EU strategy 2011-14 for social corporate responsibility.
Maltese: • L-istrateġija mġedda tal-UE 2011-14 għar-responsabilità korporattiva soċjali.
English: 7 June 2012
Maltese: 7 ta' Ġunju 2012
English: Annual report 2011
Maltese: Rapport annwali 2011
English: The members of the group are: Marcus Müllner, Luca Pani, Kristin Raudsepp, Andrzej Rys, Gro Wesenberg and Kent Woods.
Maltese: Marcus Müllner, Luca Pani, Kristin Raudsepp, Andrzej Rys, Gro Wesenberg u Kent Woods.
English: Mary Geraldine Baker participated as an observer on Wednesday, 21 March 2012
Maltese: Mary Geraldine Baker ħadet sehem bħala osservatriċi l-Erbgħa, 21 ta' Marzu 2012
English: [EMA/MB/47692/2012] The agenda was adopted.
Maltese: [EMA/MB/47692/2012] L-aġenda ġiet adottata.