About this medicine
- Approved name
- Protelos and Osseor
- International non-proprietary name (INN) or common name
- strontium ranelate
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A20/1371/C/00560-561/0039-0034
- 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
- 16/05/2013
- PRAC recommendation date
- 09/01/2014
- CHMP opinion date
- 20/02/2014
- EC decision date
- 15/04/2014
- Outcome
- Variation