United States - English - 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 )]

Singapore - English - HSA (Health Sciences Authority)

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

Israel - English - Ministry of Health

amgen europe b.v. - romiplostim - powder for solution for injection - romiplostim 250 mcg/vial - romiplostim - romiplostim - 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).

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.

Israel - English - Ministry of Health

amgen europe b.v. - romiplostim - powder for solution for injection - romiplostim 500 mcg/vial - romiplostim - nplate is indicated for chronic immune (idiopathic) thrombocytopenic purpura (itp) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

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.

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).

Singapore - English - HSA (Health Sciences Authority)

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

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

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