Septanest and associated names

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

Overview

On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other names) and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.

Key facts

Approved name
Septanest and associated names
International non-proprietary name (INN) or common name

articaine (hydrochloride) / adrenaline (tartrate)

Class
local anaesthetic
Reference number
EMEA/H/A-30/1461
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.

Status
European Commission final decision
Opinion date
28/06/2018
EC decision date
28/03/2019

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:

News

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