EMLA cream and associated names

Current status:
European Commission final decision

Overview

On 25 September 2014, the European Medicines Agency completed a review of EMLA cream. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for EMLA cream in the European Union (EU).

Key facts

Approved name
EMLA cream and associated names
International non-proprietary name (INN) or common name
lidocaine / prilocaine
Reference number
EMEA/H/A-30/1388
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
25/09/2014
EC decision date
28/11/2014

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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