Xtandi Den Europæiske Union - dansk - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamide - prostatiske neoplasmer - endokrine terapi - 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.

Talzenna Den Europæiske Union - dansk - EMA (European Medicines Agency)

talzenna

pfizer europe ma eeig - talazoparib - bryst neoplasmer - antineoplastiske midler - talzenna er angivet som monoterapi til behandling af voksne patienter med germline brca1/2 mutationer, der har her2-negative lokalt fremskreden eller metastatisk brystkræft. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. patienter med hormon receptor (hr)-positiv brystkræft skulle have været behandlet med en forudgående endokrine-baseret terapi, eller anses uegnet til at endokrine-baseret terapi.

Rukobia Den Europæiske Union - dansk - EMA (European Medicines Agency)

rukobia

viiv healthcare b.v. - fostemsavir trometamol - hiv infektioner - antivirale midler til systemisk anvendelse - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.