Tecartus Ευρωπαϊκή Ένωση - Εσθονικά - EMA (European Medicines Agency)

tecartus

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - lümfoom, mantle-cell - antineoplastilised ained - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Enhertu Ευρωπαϊκή Ένωση - Εσθονικά - EMA (European Medicines Agency)

enhertu

daiichi sankyo europe gmbh - trastuzumab deruxtecan - rinnanäärmed - antineoplastilised ained - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Orladeyo Ευρωπαϊκή Ένωση - Εσθονικά - EMA (European Medicines Agency)

orladeyo

biocryst ireland limited - berotralstat dihydrochloride - angioödeem, pärilik - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Jemperli Ευρωπαϊκή Ένωση - Εσθονικά - EMA (European Medicines Agency)

jemperli

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Lutetium (177Lu) chloride Billev (previously Illuzyce) Ευρωπαϊκή Ένωση - Εσθονικά - EMA (European Medicines Agency)

lutetium (177lu) chloride billev (previously illuzyce)

billev pharma aps - lutetium (177lu) chloride - radionukliidi pildistamine - terapeutilised radiofarmatseutilised ühendid - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.