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

novartis pharmaceuticals corporation - panobinostat lactate (unii: hn0t99oo4v) (panobinostat - unii:9647fm7y3z) - panobinostat 10 mg - farydak, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. this indication is approved under accelerated approval based on progression free survival [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none risk summary farydak can cause fetal harm when administered to a pregnant woman. panobinostat was teratogenic in rats and rabbits. if farydak is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. data animal data in embryofetal development studies, panobinostat was administered orally 3 times per week during the period of organogenesis to pregnant rats (30, 100, and 300 mg/kg) and rabbits (10, 40, and 80 mg/kg). i

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

novartis pharmaceuticals australia pty ltd - panobinostat lactate -

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

novartis pharmaceuticals australia pty ltd - panobinostat lactate -

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

novartis pharmaceuticals australia pty ltd - panobinostat lactate -

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

secura bio, inc. - panobinostat lactate (unii: hn0t99oo4v) (panobinostat - unii:9647fm7y3z) - farydak, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. this indication is approved under accelerated approval based on progression free survival [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none risk summary farydak can cause fetal harm when administered to a pregnant woman. panobinostat was teratogenic in rats and rabbits. if farydak is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. data animal data in embryofetal development studies, panobinostat was administered orally 3 times per week during the period of organogenesis to pregnant rats (30, 100, and 300 mg/kg) and rabbits (10, 40, and 80 mg/kg). in

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - panobinostat lactate anhydrous - multiple myeloma - antineoplastic agents - farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

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

novartis pharmaceuticals uk ltd - panobinostat lactate anhydrous - capsule - 10mg

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

novartis pharmaceuticals uk ltd - panobinostat lactate anhydrous - capsule - 15mg

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

novartis pharmaceuticals uk ltd - panobinostat lactate anhydrous - capsule - 20mg

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - panobinostat lactate anhydrous 12.576mg eqv panobinostat - capsule - panobinostat lactate anhydrous 12.576mg eqv panobinostat 10 mg