About this medicine
- Approved name
- Saroten and associated names
- International non-proprietary name (INN) or common name
- amitriptyline
- Associated names
- Saroten Retard
- Redomex
- Redomex Diffucaps
- Saroten Tabs
- Saroten retard Tabs
- Saroten 2ml
- Sarotex
- Sarotex Retard
- Sarotex Retard 25
- Sarotex Retard 50
- Class
- antidepressant
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-30/1430
- Type
- Article 30 referrals
This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.
Key dates and outcomes
- CHMP opinion date
- 23/02/2017
- EC decision date
- 08/05/2017