Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - neoplażmi tas-sider - terapija endokrinali - fulvestrant huwa indikat għall-kura ta ' pożittiv għar-riċetturi tal-estroġenu, lokalment avvanzat jew tal-kanċer tas-sider metastatiku fin-nisa wara l-menopawża:ma kinux ittrattati qabel b'terapija endokrinali, orwith rikaduta tal-marda fuq jew wara l-adjuvant kontra l-estroġenu-terapija, jew progressjoni tal-marda fuq antiestrogen-terapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide hydrochloride - tromboċitemja, essenzjali - aġenti antineoplastiċi - anagrelide huwa indikat għat-tnaqqis tal-għadd għoli tal-plejtlets f'mill-riskju tromboċitemja essenzjali (et) tal-pazjenti li jkunu intolleranti għall it-terapija attwali tagħhom jew li l-għadd għoli tal-plejtlets tagħhom ma jitnaqqasx għal-livell aċċettabbli bit-terapija attwali tagħhom. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - aġenti antitrombotiċi - prasugrel mylan, ko-amministrat ma ' acetylsalicylic acid (asa), huwa indikat għall-prevenzjoni ta'avvenimenti aterotrombotiċi f'pazjenti adulti b'sindromu koronarju akut (i. anġina instabbli, mhux tas-segment st 'infart mijokardijaku b'elevazzjoni [ua/nstemi] jew elevazzjoni tas-segment st' infart mijokardijaku [stemi]) li għaddejjin minn primarju jew ittardjat ta ' intervent koronarju perkutaneju (pci).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - antineoplastic agents, protein kinase inhibitors - gefitinib mylan huwa indikat bħala monoterapija għall-kura ta 'pazjenti adulti b'lokalment avvanzat jew dak metastatiku li mhux ta' ċelluli żgħar kanċer tal-pulmun (nsclc) b'mutazzjonijiet li jattivaw ta ' egfr‑tk.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasirox - iron overload; beta-thalassemia - aġenti kelanti tal-ħadid - deferasirox mylan huwa indikat għall-kura ta 'tagħbija żejda kronika tal-ħadid minħabba trasfużjonijiet tad-demm frekwenti (≥7 ml/kg/xahar ta' ċelloli ħomor ippakkjati) f'pazjenti bil-beta talassemija maġġuri ta '6 snin u l-olderthe-trattament tal-eċċess kroniku ta'ħadid minħabba trasfużjonijiet tad-demm meta terapija b'deferoxamine tkun kontra-indikata jew inadegwata f'dawn gruppi ta' pazjenti:f'pazjenti pedjatriċi b'beta-talessimja maġġuri b'tagħbija żejda tal-ħadid minħabba trasfużjonijiet tad-demm frekwenti (≥7 ml/kg/xahar ta ' ċelloli ħomor ippakkjati) b'età minn 2 sa 5 snin,fl-adulti u f'pazjenti pedjatriċi bil-beta talassemija maġġuri b'tagħbija żejda tal-ħadid minħabba trasfużjonijiet tad-demm frekwenti (.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - clopidogrel/acetylsalicylic acid mylan huwa indikat għall-prevenzjoni sekondarja ta ' avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qed jieħdu ż-żewġ clopidogrel u acetylsalicylic acid (asa). clopidogrel/acetylsalicylic acid mylan huwa kombinazzjoni b'doża fissa tal-prodott mediċinali għall-kontinwazzjoni tat-terapija:mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku) li jinkludu pazjenti fi proċess li titpoġġa stent wara koronarju perkutanju interventionst elevazzjoni tas-segment infart mijokardijaku akut fil-medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - lewkimja, linfokitika, kronika, b-Ċellula - aġenti antineoplastiċi - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ombitasvir, paritaprevir, ritonavir - epatite Ċ, kronika - antivirali għal użu sistemiku - viekirax huwa indikat flimkien ma 'prodotti mediċinali oħra għall-kura ta' l-epatite Ċ kronika (chc) fl-adulti. għall-vajrus tal-epatite Ċ (hcv) ġenotip attività speċifika.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - epatite Ċ, kronika - antivirali għal użu sistemiku - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.