About this medicine
- Approved name
- Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
- International non-proprietary name (INN) or common name
- daclatasvir
- dasabuvir
- sofosbuvir
- ledipasvir
- simeprevir
- ombitasvir
- paritaprevir
- ritonavir
- Associated names
- Sovaldi
- Olysio
- Viekirax
- Harvoni
- Exviera
- Daklinza
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-20/1438
- 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
- 17/03/2016
- PRAC recommendation date
- 01/12/2016
- CHMP opinion date
- 15/12/2016
- EC decision date
- 23/02/2017
- Outcome
- Risk minimisation measures