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INDUSTRY:

Pharma

TOPIC:

Regulatory & Legal

TITLE:

EMA: On the 18 September 2017, the European Commission granted a Marketing Authorisation for Rydapt (midostaurin), indicated: - in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive. - as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL). The Marketing Authorization Holder for this medicinal product is Novartis Europharm Ltd.

BRIEF:

EMA: EC granted the Marketing Authorisation for Rydapt (midostaurin) 25 mg soft capsules from Novartis Europharm Ltd. Rydapt is indicated - in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive. - as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL). (ATC code: L01XE).

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