Libtayo Európai Unió - magyar - EMA (European Medicines Agency)

libtayo

regeneron ireland designated activity company (dac) - cemiplimab - karcinóma, squamous cell - daganatellenes szerek - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Venclyxto Európai Unió - magyar - EMA (European Medicines Agency)

venclyxto

abbvie deutschland gmbh co. kg - venetoclax - leukémia, limfocitikus, krónikus, b-sejt - daganatellenes szerek - 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.

Camzyos Európai Unió - magyar - EMA (European Medicines Agency)

camzyos

bristol-myers squibb pharma eeig - mavacamten - cardiomyopathy, hypertrophic - egyéb szívkészítmények - treatment of symptomatic obstructive hypertrophic cardiomyopathy.

Modigraf Európai Unió - magyar - EMA (European Medicines Agency)

modigraf

astellas pharma europe b.v. - takrolimusz - graft visszautasítás - immunszuppresszánsok - a transzplantációs kilökődés a felnőtt és a gyermekgyógyászati, a vese, a máj vagy a szív allograft címzettek profilaxis. kezelés allograft elutasítás ellenáll a kezelés egyéb immunszuppresszív gyógyszerek a felnőtt, illetve gyermekkorú.