EMA — authorised 3 September 2012
- Marketing authorisation holder: Novo Nordisk A/S
- Status: approved
🇪🇺 Novothirteen in European Union
EMA authorised Novothirteen on 3 September 2012
Marketing authorisations
EMA — authorised 3 September 2012
- Application: EMEA/H/C/002284
- Marketing authorisation holder: Novo Nordisk A/S
- Local brand name: NovoThirteen
- Indication: Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.
- Status: approved
Novothirteen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Novothirteen approved in European Union?
Yes. EMA authorised it on 3 September 2012; EMA authorised it on 3 September 2012.
Who is the marketing authorisation holder for Novothirteen in European Union?
Novo Nordisk A/S holds the EU marketing authorisation.