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

vyvgart

argenx - efgartigimod alfa - myasthenia gravis - immunosoppressanti - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

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

pepaxti

oncopeptides ab - melphalan flufenamide hydrochloride - majloma multipla - aġenti antineoplastiċi - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

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

livmarli

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

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

akeega

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatika neoplażmi, il-kastrazzjoni-reżistenti - aġenti antineoplastiċi - treatment of adult patients with prostate cancer.

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

tibsovo

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - aġenti antineoplastiċi - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

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

vanflyta

daiichi sankyo europe gmbh - quizartinib dihydrochloride - lewkimja, myeloid - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.