Euroopan unioni - suomi - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - rokotteet - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older. käyttö tämä rokote tulee virallisten suositusten mukaisesti.

Euroopan unioni - suomi - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuklidien kuvantaminen - terapeuttiset radiofarmaseuttiset valmisteet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemia, myelogeeninen, krooninen, bcr-abl positiivinen - antineoplastiset aineet - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple myeloma - antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited  - lutetium (177lu) vipivotide tetraxetan - eturauhasen kasvaimet, kastraatio-resistentin - terapeuttiset radiofarmaseuttiset valmisteet - pluvicto in combination with androgen deprivation therapy (adt) with or without androgen receptor (ar) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with ar pathway inhibition and taxane based chemotherapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - eturauhasen kasvaimet, kastraatio-resistentin - antineoplastiset aineet - treatment of adult patients with prostate cancer.

Euroopan unioni - suomi - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antineoplastiset aineet - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukemia, myeloidi - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - prekursorisolujen lymfoblastinen leukemia-lymfooma - antineoplastiset aineet - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.