Nplate (romiplostim)
- Region
- 🇪🇺 EU
- Active substance
- romiplostim
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Purpura, Thrombocytopenic, Idiopathic
- CHMP opinion
- Thu 20 Nov 2008
- EU approval
- Wed 04 Feb 2009
- Application
- EMEA/H/C/000942
- ATC
- B02BX04
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.