Nplate® (romiplostim)

BL 125268

Nplate® (romiplostim)

BL 125268

U.S. License Holder:

Amgen

Date of License:

August-22-2008

Last Update:

January-23-2023

approved_indications FDA-Approved Indications

NPLATE (romiplostim) is a thrombopoietin receptor agonist 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 (Hematopoietic Syndrome of Acute Radiation Syndrome [HS­ARS]).

Methodology

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