Venclyxto Unjoni Ewropea - Malti - EMA (European Medicines Agency)

venclyxto

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.

Afstyla Unjoni Ewropea - Malti - EMA (European Medicines Agency)

afstyla

csl behring gmbh - lonoctocog alfa - hemofilja a - sustanzi kontra l-emorraġija - trattament u profilassi ta 'fsada f'pazjenti b'emofilja a (nuqqas konġenitali ta' fattur viii). afstyla jistgħu jiġu użati għall-gruppi kollha tal-età.

Vfend Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vfend

pfizer europe ma eeig - voriconazole - candidiasis; mycoses; aspergillosis - antimikotiċi għal użu sistemiku - voriconazole, huwa triazole bi spettru wiesa'li aġent antifungali u hija indikata fl-adulti u t-tfal b'età minn 2 snin u l-fuq kif ġej:trattament ta 'asperġillożi invażiva;it-trattament tal fil-candidaemianon-pazjenti newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji candida reżistenti (inkluż c. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn scedosporium spp. u fusarium spp. vfend għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet. profilassi ta ' infezzjonijiet fungali invażivi f'riskju għoli alloġeneiċi trapjant ta'ċelloli staminali ematopojetiċi (hsct) riċevituri.

Xtandi Unjoni Ewropea - Malti - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamide - neoplasmi prostatiċi - terapija endokrinali - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Yargesa Unjoni Ewropea - Malti - EMA (European Medicines Agency)

yargesa

piramal critical care b.v. - miglustat - mard gaucher - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - yargesa huwa indikat għat-trattament orali ta ' pazjenti adulti b'indeboliment ħafif għal moderata tat-tip 1 tal-marda gaucher. yargesa jistgħu jintużaw biss fil-kura ta ' pazjenti li għalihom it-terapija enzimatika sostituttiva mhuwiex adattat. yargesa huwa indikat għall-kura ta 'manifestazzjonijiet newroloġiċi progressivi f'pazjenti adulti u f'pazjenti pedjatriċi bil-marda ta' niemann-pick ta ' tip Ċ-marda.

Zalviso Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zalviso

fgk representative service gmbh - sufentanil - uġigħ, wara l-operazzjoni - anestetiċi - zalviso huwa indikat għall-immaniġġjar ta 'uġigħ akut ta' wara l-operazzjoni moderat għal sever f'pazjenti adulti.

Melatonin Neurim Unjoni Ewropea - Malti - EMA (European Medicines Agency)

melatonin neurim

rad neurim pharmaceuticals eec sarl - melatonin - sleep inizjattiva u maintenance disorders - psikolettiċi - melatonin neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.

Apretude Unjoni Ewropea - Malti - EMA (European Medicines Agency)

apretude

viiv healthcare b.v. - cabotegravir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4. 2, 4. 4 u 5.