Piasky (crovalimab)
- Region
- 🇪🇺 EU
- Active substance
- crovalimab
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Hemoglobinuria, Paroxysmal
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006061
- ATC
- L04AJ07
- Official record
- www.ema.europa.eu
Indication
Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): In patients with haemolysis with clinical symptom(s) indicative of high disease activity. In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.
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.