About this medicine
- Approved name
- Zynteglo
- International non-proprietary name (INN) or common name
- betibeglogene autotemcel
- Associated names
- Zynteglo
- Class
- Haematological agents
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-20/1504/C/003691/0023
- 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-CAT-CHMP-EC
Key dates and outcomes
- Procedure start date
- 11/03/2021
- PRAC recommendation date
- 09/07/2021
- CHMP opinion date
- 22/07/2021
- EC decision date
- 16/09/2021
- Outcome
- Risk minimisation measures