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NPLATE (Amgen Australia Pty Ltd)
Product name
NPLATE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
216 working days (255)
Active ingredients
romiplostim (rbe)
Registration type
EOI
Indication
NPLATE (powder for injection) is now also indicated for treatment of thrombocytopenia in patients aged 1 year and older with chronic immune (idiopathic) thrombocytopenic purpura (ITP):
- who are non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins;
- who are splenectomised and have had an inadequate response to splenectomy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.