Israel - English - Ministry of Health

novartis israel ltd - midostaurin - capsules soft - midostaurin 25 mg - midostaurin - acute myeloid leukaemia (aml) :rydapt is indicated in combination with standard induction and consolidation chemotherapy followed by single-agent maintenance therapy for adults with newly diagnosed acute myeloid leukaemia (aml) who have an flt3 mutation.advanced systemic mastocytosis (advanced sm) :rydapt is indicated for the treatment of adult patients with advanced systemic mastocytosis (advanced sm).

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - midostaurin (unii: id912s5von) (midostaurin - unii:id912s5von) - midostaurin 25 mg - rydapt is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (aml) who are flt3 mutation-positive, as detected by an fda approved test [see dosage and administration (2.1), clinical studies (14.1)]. limitations of use rydapt is not indicated as a single-agent induction therapy for the treatment of patients with aml. rydapt is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with associated hematological neoplasm (sm-ahn), or mast cell leukemia (mcl). rydapt is contraindicated in patients with hypersensitivity to midostaurin or to any of the excipients [see description (11)]. hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) [see adverse reactions (6.1)]. pregnanc

European Union - English - EMA (European Medicines Agency)

novartis europharm ltd - midostaurin - leukemia, myeloid, acute; mastocytosis - antineoplastic agents - 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 (see section 4.2);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).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - midostaurin - capsule - 25mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - midostaurin -

Canada - English - Health Canada

novartis pharmaceuticals canada inc - midostaurin - capsule - 25mg - midostaurin 25mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - midostaurin 25mg - soft gelatin capsule - 25 mg - active: midostaurin 25mg excipient: corn oil, ethoxylated dl-alpha tocopherol ethanol gelatin glycerol iron oxide red iron oxide yellow macrogol 400 peg-40 castor oil purified water red printing ink (catalent) titanium dioxide - rydapt® is indicated: · in combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients in complete response by single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (aml) who are flt3 mutation-positive · for the treatment of adult patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with associated haematological neoplasms (sm-ahn), or mast cell leukaemia (mcl).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - midostaurin, quantity: 25 mg - capsule, soft - excipient ingredients: corn oil peg-6 esters; gelatin; peg-40 hydrogenated castor oil; macrogol 400; titanium dioxide; glycerol; dl-alpha-tocopherol; purified water; iron oxide red; iron oxide yellow; ethanol; hypromellose; propylene glycol; isopropyl alcohol; aluminium chloride; sodium hydroxide; cochineal - rydapt is indicated:,? in combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients in complete response by single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (aml) who are flt3 mutation-positive ? for the treatment of adult patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with associated haematological neoplasms (sm-ahn), or mast cell leukaemia (mcl).

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - midostaurin - capsule, liquid filled - midostaurin 25mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

novartis pharma ag - midostaurina - midostaurina....25.00 mg.