EMLA cream and associated names - referral

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).

What is EMLA cream?

EMLA cream is a topical (skin) cream that contains the active substances lidocaine and prilocaine. It is used as a local anaesthetic to prevent pain during medical or superficial surgical procedures.

EMLA cream has been nationally authorised in EU Member States since 1984.

The medicine is currently marketed in the following Member States of the EU: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.

The company that markets these medicines is Astra Zeneca.

Why was EMLA cream reviewed?

EMLA cream is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (Summary of Product Characteristics), labelling and package leaflets in the countries where the medicine is marketed.

In view of this, on 11 October 2013 the German medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for EMLA cream in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the medicine's use, the CHMP agreed that EMLA cream can be used for the following:

• topical anaesthesia of the skin in adults and children;
• topical anaesthesia of the genital mucosa in adults and adolescents;
• topical anaesthesia of leg ulcers in adults only.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised recommendations on the doses and the duration of application of EMLA cream before different medical or surgical procedures in children, adolescents or adults. In addition, information has been included to explain that studies did not show that EMLA cream is effective at providing adequate pain relief for circumcision (surgical removal of the foreskin).

4.3 Contra-indications

The CHMP agreed that hypersensitivity (allergy) to lidocaine and/or prilocaine or similar local anaesthetics or to any other ingredients in EMLA cream should be the only contraindication.

Other changes

The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects). The labelling and package leaflet were also revised in line with the changes to the SmPC.

The European Commission issued an EU-wide legally binding decision on 28 November 2014.

Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use)

Adopted Reference Number: EMA/440595/2014

Key facts

About this medicine

• Approved name:
  EMLA cream and associated names
• International non-proprietary name (INN) or common name:
  • lidocaine
  • prilocaine

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  25/09/2014
• EC decision date:
  28/11/2014

All documents

Opinion provided by Committee for Medicinal Products for human Use

EMLA cream Article-30 referral - Annex III

Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use)

Adopted Reference Number: EMA/440595/2014

European Commission final decision

EMLA cream Article-30 referral - Assessment report

Reference Number: EMA/707790/2014

EMLA cream Article-30 referral - Annex I

EMLA cream Article-30 referral - Annex II

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.