Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

amgen new zealand limited - pegfilgrastim 10 mg/ml;   - solution for injection - 6 mg/0.6ml - active: pegfilgrastim 10 mg/ml   excipient: acetic acid polysorbate 20 sodium hydroxide sorbitol water for injection - reduction in the duration of neutropenia, the incidence of febrile neutropenia and the incidence of infection as manifested by febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Malesia - inglese - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

amgen biopharmaceuticals malaysia sdn bhd - blinatumomab -

Israele - inglese - Ministry of Health

amgen europe b.v. - pegfilgrastim - solution for injection - pegfilgrastim 10 mg/ml ml - pegfilgrastim - pegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy. ( with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Israele - inglese - 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.

Israele - inglese - 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.

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

amgen australia pty ltd - water for injections -

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

amgen australia pty ltd - water for injections -

Israele - inglese - Ministry of Health

amgen europe b.v. - sotorasib - film coated tablets - sotorasib 120 mg - sotorasib - lumykras is indicated for the treatment of adult patients with kras g12c-mutated locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by an approved test, who have received at least one prior systemic therapy.

Stati Uniti - inglese - NLM (National Library of Medicine)

amgen inc - evolocumab (unii: lkc0u3a8nj) (evolocumab - unii:lkc0u3a8nj) - evolocumab 140 mg in 1 ml - repatha is indicated: - in adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization - as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c - as an adjunct to diet and other ldl-c-lowering therapies in pediatric patients aged 10 years and older with hefh, to reduce ldl-c - as an adjunct to other ldl-c-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (hofh), to reduce ldl-c repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in repatha. serious hypersensitivity reactions including angioedema have occurred in patients treated with repatha [see warnings and precautions (5.1)]. risk summary available data fr

Stati Uniti - inglese - NLM (National Library of Medicine)

amgen inc - cinacalcet hydrochloride (unii: 1k860wsg25) (cinacalcet - unii:uaz6v7728s) - cinacalcet 30 mg - sensipar is indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on dialysis [see clinical studies ( 14.1 )].   limitations of use: sensipar is not indicated for use in patients with ckd who are not on dialysis because of an increased risk of hypocalcemia [see warnings and precautions ( 5.1 )] . sensipar is indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma [see clinical studies ( 14.2 )] . sensipar is indicated for the treatment of hypercalcemia in adult patients with primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see clinical studies ( 14.3 )] . sensipar treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see warnings and precautions ( 5.1 )]. risk summary limited case reports of sensipar use in pregnant women are insufficient to inform a drug associated