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

amgen australia pty ltd - carfilzomib, quantity: 60 mg - injection, powder for - excipient ingredients: sodium hydroxide; sulfobutyl betadex sodium; citric acid - kyprolis is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy as part of combination therapy with: ? dexamethasone, or ? lenalidomide and dexamethasone, or ? daratumumab and dexamethasone, or ? isatuximab and dexamethasone

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

amgen australia pty ltd - carfilzomib, quantity: 30 mg - injection, powder for - excipient ingredients: sodium hydroxide; sulfobutyl betadex sodium; citric acid - kyprolis is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy as part of combination therapy with: ? dexamethasone, or ? lenalidomide and dexamethasone, or ? daratumumab and dexamethasone, or ? isatuximab and dexamethasone

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

onyx pharmaceuticals, inc. - carfilzomib (unii: 72x6e3j5ar) (carfilzomib - unii:72x6e3j5ar) - carfilzomib 60 mg in 30 ml - - kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: lenalidomide and dexamethasone; or dexamethasone; or daratumumab and dexamethasone; or daratumumab and hyaluronidase-fihj and dexamethasone; or isatuximab and dexamethasone. - lenalidomide and dexamethasone; or - dexamethasone; or - daratumumab and dexamethasone; or - daratumumab and hyaluronidase-fihj and dexamethasone; or - isatuximab and dexamethasone. - kyprolis is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. none. risk summary kyprolis can cause fetal harm based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] . there are no available data on kyprolis use in pregnant women to evaluate for drug-associated risks. kyprolis caused embryo-fetal lethality in rabbits at doses lower

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

amgen australia pty ltd - carfilzomib, quantity: 10 mg - injection, powder for - excipient ingredients: sodium hydroxide; sulfobutyl betadex sodium; citric acid - kyprolis is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy as part of combination therapy with: ? dexamethasone, or ? lenalidomide and dexamethasone, or ? daratumumab and dexamethasone, or ? isatuximab and dexamethasone

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

duopharma (m) sdn. bhd. - carfilzomib -

Israel - English - Ministry of Health

amgen europe b.v. - carfilzomib - powder for solution for injection - carfilzomib 2 mg/ml - carfilzomib - kyprolis is indicated: - for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy in combination with: • lenalidomide and dexamethasone; or • dexamethasone; or • daratumumab (i.v or s.c) and dexamethasone.- as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. approval is based on response rate. clinical benefit, such as improvement in survival or symptoms, has not been verified.

Israel - English - Ministry of Health

amgen europe b.v. - carfilzomib - powder for solution for injection - carfilzomib 2 mg/ml - carfilzomib - kyprolis is indicated: o for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy in combination with: • lenalidomide and dexamethasone; or • dexamethasone; or • daratumumab (i.v or s.c) and dexamethasone.o in combination with isatuximab and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.o as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. approval is based on response rate. clinical benefit, such as improvement in survival or symptoms, has not been verified.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sudair pharma company, saudi arabia - carfilzomib - powder for injection - 60 mg

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

amgen ltd - carfilzomib - powder for solution for infusion - 60mg

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

amgen ltd - carfilzomib - powder for solution for infusion - 10mg