Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

amgen ltd - blinatumomab - powder for solution for infusion - 38.5microgram

Marekani - Kiingereza - NLM (National Library of Medicine)

amgen inc - romiplostim (unii: gn5xu2dxkv) (romiplostim - unii:gn5xu2dxkv) - romiplostim 500 ug in 1 ml - nplate is indicated for the treatment of thrombocytopenia in: - adult patients with immune thrombocytopenia (itp) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. - pediatric patients 1 year of age and older with itp for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see clinical studies (14.3)] . limitations of use: - nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (mds) or any cause of thrombocytopenia other than itp [see warnings and precautions ( 5.1 )] .   - nplate should be used only in patients with itp whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. - nplate should not be used in an attempt to normalize platelet counts [see warnings and precautions ( 5.2 )]

Marekani - Kiingereza - NLM (National Library of Medicine)

amgen inc - darbepoetin alfa (unii: 15uq94pt4p) (darbepoetin alfa - unii:15uq94pt4p) - darbepoetin alfa 10 ug in 0.4 ml - aranesp is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and patients not on dialysis. aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. aranesp has not been shown to improve quality of life, fatigue, or patient well-being. aranesp is not indicated for use: •       in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. •       in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. •       in patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. •       as a substitute for rbc transfusions in patients who require immediate correction o

Marekani - Kiingereza - NLM (National Library of Medicine)

amgen inc - talimogene laherparepvec (unii: 07730v90l6) (talimogene laherparepvec - unii:07730v90l6) - talimogene laherparepvec 1000000 [pfu] in 1 ml - imlygic is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. limitations of use : imlygic has not been shown to improve overall survival or have an effect on visceral metastases. imlygic is a live, attenuated herpes simplex virus and may cause life-threatening disseminated herpetic infection in patients who are immunocompromised. do not administer imlygic to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, aids or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy [see nonclinical toxicology ( 13.2 )] . do not administer imlygic to pregnant patients. risk summary adequate and well-controlled studies with imlygic have not been conducted in pregnant women. no effects on embryo-fetal development have been observed in a stu

Kanada - Kiingereza - Health Canada

amgen canada inc - blinatumomab - powder for solution - 38.5mcg - blinatumomab 38.5mcg - antineoplastic agents

Singapoo - Kiingereza - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - blinatumomab - injection, powder, lyophilized, for solution - blinatumomab 55.0 μg/ml

Marekani - Kiingereza - NLM (National Library of Medicine)

amgen inc - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - avsola is indicated for: - reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn's disease (cd) who have had an inadequate response to conventional therapy. - reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing cd. avsola is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active cd who have had an inadequate response to conventional therapy. avsola is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response to conventional therapy. avsola is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in

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

amgen biopharmaceuticals malaysia sdn bhd - romosozumab -

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

amgen inc., united states - blinatumomab - powder for concentrate for solution for infusion - 35 µg

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

amgen inc., united states - blinatumomab - powder for concentrate for solution for infusion - 35 µg