EMA — authorised 7 October 2002
- Application: EMEA/H/C/000424
- Marketing authorisation holder: Novo Nordisk A/S
- Local brand name: Actrapid
- Indication: Treatment of diabetes mellitus.
- Status: approved
🇪🇺 Fast-acting human insulin in European Union
EMA authorised Fast-acting human insulin on 7 October 2002
Marketing authorisation
Fast-acting human insulin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Fast-acting human insulin approved in European Union?
Yes. EMA authorised it on 7 October 2002.
Who is the marketing authorisation holder for Fast-acting human insulin in European Union?
Novo Nordisk A/S holds the EU marketing authorisation.