About this medicine
- Approved name
- Kogenate Bayer and Helixate NexGen
- International non-proprietary name (INN) or common name
- octocog alfa
- Class
- -
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/C/275/A20/150, EMEA/H/C/276/A20/143
- Type
- Article 20 procedures
This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
- Authorisation model
- Centrally authorised product(s)
- Decision making model
- PRAC-CHMP-EC
Key dates and outcomes
- Procedure start date
- 07/03/2013
- PRAC recommendation date
- 05/12/2013
- CHMP opinion date
- 19/12/2013
- EC decision date
- 20/02/2014
- Outcome
- Variation