Saroten and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision


Outcome of a procedure under Article 30 of Directive 2001/83/EC

On 23 February 2017, the European Medicines Agency completed a review of Saroten. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for amitriptyline in the European Union (EU).

Key facts

Approved name
Saroten and associated names
International non-proprietary name (INN) or common name
Associated names
  • Saroten Retard
  • Redomex
  • Redomex Diffucaps
  • Saroten Tabs
  • Saroten retard Tabs
  • Saroten 2ml
  • Sarotex
  • Sarotex Retard
  • Sarotex Retard 25
  • Sarotex Retard 50
Reference number
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.

European Commission final decision
Opinion date
EC decision date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:


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