NPLATE (Amgen Australia Pty Ltd)
Product name
NPLATE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 (255 working days)
Active ingredients
romiplostim
Registration type
EOI
Indication
Adults
NPLATE (powder for injection) is now also 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.