NovoThirteen (catridecacog)
- Region
- 🇪🇺 EU
- Active substance
- catridecacog
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Blood Coagulation Disorders, Inherited
- CHMP opinion
- Thu 24 May 2012
- EU approval
- Mon 03 Sep 2012
- Application
- EMEA/H/C/002284
- ATC
- B02BD11
- Official record
- www.ema.europa.eu
Indication
Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.
Regulatory milestones
No milestones recorded in the last year.
Follow NovoThirteen
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.