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

amgen australia pty ltd - romiplostim, quantity: 625 microgram - injection, powder for - excipient ingredients: dilute hydrochloric acid; mannitol; polysorbate 20; histidine; sucrose - adults,nplate is indicated for treatment of thrombocytopenia in adult patients with primary immune thrombocytopenia (itp) who are:,? non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.,paediatrics,nplate is indicated for treatment of thrombocytopenia in paediatric patients aged 1 year and older with primary immune thrombocytopenia itp for at least 6 months who are:,? non-splenectomised and have had an insufficient response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.

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

amgen australia pty ltd - romiplostim, quantity: 375 microgram - injection, powder for - excipient ingredients: sucrose; mannitol; polysorbate 20; histidine; dilute hydrochloric acid - adults,nplate is indicated for treatment of thrombocytopenia in adult patients with primary immune thrombocytopenia (itp) who are:,? non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.,paediatrics,nplate is indicated for treatment of thrombocytopenia in paediatric patients aged 1 year and older with primary immune thrombocytopenia itp for at least 6 months who are:,? non-splenectomised and have had an insufficient response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.

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

amgen australia pty ltd - romiplostim, quantity: 230 microgram - injection, powder for - excipient ingredients: histidine; sucrose; polysorbate 20; dilute hydrochloric acid; mannitol - adults,nplate is indicated for treatment of thrombocytopenia in adult patients with primary immune thrombocytopenia (itp) who are:,? non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.,paediatrics,nplate is indicated for treatment of thrombocytopenia in paediatric patients aged 1 year and older with primary immune thrombocytopenia itp for at least 6 months who are:,? non-splenectomised and have had an insufficient response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.

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

amgen australia pty ltd - romiplostim -

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - romiplostim - purpura, thrombocytopenic, idiopathic - antihemorrhagics - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

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

amgen ltd - romiplostim - powder and solvent for solution for injection - 250microgram

Singapore - English - HSA (Health Sciences Authority)

kyowa hakko kirin (singapore) pte. ltd. - romiplostim - injection, powder, for solution - romiplostim 375μg/vial (deliverable amt 250μg/vial)

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

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

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