Scandonest and associated names

Current status:
European Commission final decision

Overview

Use of Scandonest and associated names (mepivacaine) to be harmonised

Information for doctors and patients to be aligned across EU

On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated 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
Scandonest and associated names
International non-proprietary name (INN) or common name
mepivacaine
Associated names
  • Biocaine
  • Scandicaine
Class
Anaesthetic
Reference number
EMEA/H/A-30/1455
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
31/05/2018
EC decision date
02/08/2018

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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