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Evenity® Inj. Pre-filled Syringe

  • Product Name (Korean) 이베니티주 프리필드시린지(로모소주맙)
  • Product Name (English) Evenity® Inj. Pre-filled Syringe(romosozumab)
  • Active Ingredient (Korean) 로모소주맙
  • Active Ingredient (English) romosozumab
  • API content 105mg/1.17mL
  • Excipients Calcium acetate, Acetate acid, glacial, Sucrose, Polysorbate 20, Sodium hydroxide, Water for injection, Sterilized injection needle
  • Treatment Osteoporosis
  • Indications
    1. Treatment of osteoporosis in postmenopausal women at high risk of fracture.
    2. Osteoporosis in men at high risk of fracture to increase bone mass.
  • Evenity® Medication Guide

BLINCYTO® Inj. 35 μg

  • Product Name (Korean) 블린사이토주 35μg
  • Product Name (Engilsh) BLINCYTO®  Inj. 35μg
  • Active Ingredient (Korean) 블리나투모맙
  • Active Ingredient (English) blinatumomab
  • API content 35μg/1 vial
  • Excipients

    Citric Acid Monohydrate, Lysine Hydrochloride (stabilizer, 25.55 mg), Polysorbate 80, Trehalose Dihydrate (stabilizer, 105.0 mg), Sodium Hydroxide

    [IV Solution Stabilizer] 1 vial (10 mL) containsCitric Acid Monohydrate (52.5 mg), Lysine Hydrochloride (2283.8 mg), Polysorbate 80 (10 mg), Sodium Hydroxide (q.s.), Water For Injection (q.s.)

  • Treatment Anti-malignant tumor agent
  • Indications Treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children
  • BLINCYTO® Medication Guide

KYPROLIS® Inj. 60mg, 30mg

  • Product Name (Korean) 키프롤리스주 60mg, 키프롤리스주 30mg
  • Product Name (English) Kyprolis®  Inj. 60mg, Kyprolis®  Inj. 30mg
  • Active Ingredient (Korean) 카르필조밉
  • Active Ingredient (English) carfilzomib
  • API content 60 mg/vial, 30 mg/vial
  • Excipients Betadex sulfobutyl ether sodium (SBECD), Anhydrous citric acid, Sodium hydroxide
  • Treatment Treatment of multiple myeloma.
  • Indications The combination therapy with lenalidomide and dexamethasone or with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
  • KYPROLIS® Medication Guide

Prolia® Pre-filled Syringe 

  • Product Name (Korean) 프롤리아® 프리필드시린지
  • Product Name (English) Prolia® Pre-filled Syringe
  • Active Ingredient (Korean) 데노수맙
  • Active Ingredient (English) denosumab
  • API content 60 mg/1 mL
  • Excipients Sorbitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injection, injection needle
  • Treatment Treatment of osteoporosis.
  • Indications
    1. Treatment of postmenopausal women with osteoporosis.
    2. Treatment to increase bone mass in men with osteoporosis.
    3. Treatment of Glucocorticoid-Induced Osteoporosis
    4. Treatment of bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer.
    5. Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
  • Prolia® Medication Guide

XGEVA® Injection

  • Product Name (Korean) 엑스지바®
  • Product Name (English) Xgeva® Injection
  • Active Ingredient (Korean) 데노수맙
  • Active Ingredient (English) denosumab
  • API content 120 mg/1.7 mL
  • Excipients Sorbitol, glacial acetic acid, sodium hydroxide, water for injection
  • Treatment Treatment of serious bone problems in patients with bone metastases from solid tumors and multiple myeloma.
  • Indications
    1. Reduction of the risk for developing skeletal-related events in patients with bone metastases from solid tumors and multiple myeloma. Skeletal-related events refers to pathological fractures, radiation to bone, spinal cord compression, and bone surgery.
    2. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • XGEVA® Medication Guide

Repatha® Inj. Pre-filled pen

  • Product Name (Korean) 레파타주 프리필드펜
  • Product Name (English) Repatha® Inj. Pre-filled pen
  • Active Ingredient (Korean) 에볼로쿠맙
  • Active Ingredient (English) evolocumab
  • API content 140 mg/1.0 mL
  • Excipients Proline, Acetic acid, glacial, Polysorbate 80, Sodium hydroxide, Sterilized needle
  • Treatment Anti-atherosclerotic agent
  • Indications
      1) Hypercholesterolemia and mixed dyslipidemia
      THIS DRUG is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.
      2) Homozygous Familial Hypercholesterolemia
      THIS DRUG is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies (e.g., statins, LDL apheresis).
      3) Atherosclerotic cardiovascular disease
      THIS DRUG is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies.
  • Repatha® Medication Guide