EMLA cream and associated names

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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.

Name Language First published Last updated
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) BG = bălgarski 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) ES = español 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) CS = čeština 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) DA = dansk 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) DE = Deutsch 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) ET = eesti keel 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) EL = elliniká 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) EN = English 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) FR = français 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) IT = italiano 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) LV = latviešu valoda 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) LT = lietuvių kalba 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) HU = magyar 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) MT = Malti 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) NL = Nederlands 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) PL = polski 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) PT = português 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) RO = română 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) SK = slovenčina 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) SL = slovenščina 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) FI = suomi 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) SV = svenska 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) HR = Hrvatski 2014-09-26 2015-01-15

Key facts

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

lidocaine / prilocaine

Associated names
Class
Reference numberEMEA/H/A-30/1388
TypeArticle 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 European Union.

StatusEuropean Commission final decision
Opinion date25/09/2014

All documents

Name Language First published Last updated
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) BG = bălgarski 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) ES = español 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) CS = čeština 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) DA = dansk 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) DE = Deutsch 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) ET = eesti keel 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) EL = elliniká 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) EN = English 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) FR = français 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) IT = italiano 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) LV = latviešu valoda 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) LT = lietuvių kalba 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) HU = magyar 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) MT = Malti 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) NL = Nederlands 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) PL = polski 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) PT = português 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) RO = română 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) SK = slovenčina 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) SL = slovenščina 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) FI = suomi 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) SV = svenska 2014-09-26 2015-01-15
Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use) HR = Hrvatski 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Assessment report (English only) 2015-01-15  
EMLA cream Article-30 referral - Annex I BG = bălgarski 2015-01-15  
EMLA cream Article-30 referral - Annex I ES = español 2015-01-15  
EMLA cream Article-30 referral - Annex I CS = čeština 2015-01-15  
EMLA cream Article-30 referral - Annex I DA = dansk 2015-01-15  
EMLA cream Article-30 referral - Annex I DE = Deutsch 2015-01-15  
EMLA cream Article-30 referral - Annex I ET = eesti keel 2015-01-15  
EMLA cream Article-30 referral - Annex I EL = elliniká 2015-01-15  
EMLA cream Article-30 referral - Annex I EN = English 2015-01-15  
EMLA cream Article-30 referral - Annex I FR = français 2015-01-15  
EMLA cream Article-30 referral - Annex I IT = italiano 2015-01-15  
EMLA cream Article-30 referral - Annex I LV = latviešu valoda 2015-01-15  
EMLA cream Article-30 referral - Annex I LT = lietuvių kalba 2015-01-15  
EMLA cream Article-30 referral - Annex I HU = magyar 2015-01-15  
EMLA cream Article-30 referral - Annex I MT = Malti 2015-01-15  
EMLA cream Article-30 referral - Annex I NL = Nederlands 2015-01-15  
EMLA cream Article-30 referral - Annex I PL = polski 2015-01-15  
EMLA cream Article-30 referral - Annex I PT = português 2015-01-15  
EMLA cream Article-30 referral - Annex I RO = română 2015-01-15  
EMLA cream Article-30 referral - Annex I SK = slovenčina 2015-01-15  
EMLA cream Article-30 referral - Annex I SL = slovenščina 2015-01-15  
EMLA cream Article-30 referral - Annex I FI = suomi 2015-01-15  
EMLA cream Article-30 referral - Annex I SV = svenska 2015-01-15  
EMLA cream Article-30 referral - Annex I HR = Hrvatski 2015-01-15  
EMLA cream Article-30 referral - Annex I IS = Islenska 2015-01-15  
EMLA cream Article-30 referral - Annex I NO = Norsk 2015-01-15  
EMLA cream Article-30 referral - Annex II BG = bălgarski 2015-01-15  
EMLA cream Article-30 referral - Annex II ES = español 2015-01-15  
EMLA cream Article-30 referral - Annex II CS = čeština 2015-01-15  
EMLA cream Article-30 referral - Annex II DA = dansk 2015-01-15  
EMLA cream Article-30 referral - Annex II DE = Deutsch 2015-01-15  
EMLA cream Article-30 referral - Annex II ET = eesti keel 2015-01-15  
EMLA cream Article-30 referral - Annex II EL = elliniká 2015-01-15  
EMLA cream Article-30 referral - Annex II EN = English 2015-01-15  
EMLA cream Article-30 referral - Annex II FR = français 2015-01-15  
EMLA cream Article-30 referral - Annex II IT = italiano 2015-01-15  
EMLA cream Article-30 referral - Annex II LV = latviešu valoda 2015-01-15  
EMLA cream Article-30 referral - Annex II LT = lietuvių kalba 2015-01-15  
EMLA cream Article-30 referral - Annex II HU = magyar 2015-01-15  
EMLA cream Article-30 referral - Annex II MT = Malti 2015-01-15  
EMLA cream Article-30 referral - Annex II NL = Nederlands 2015-01-15  
EMLA cream Article-30 referral - Annex II PL = polski 2015-01-15  
EMLA cream Article-30 referral - Annex II PT = português 2015-01-15  
EMLA cream Article-30 referral - Annex II RO = română 2015-01-15  
EMLA cream Article-30 referral - Annex II SK = slovenčina 2015-01-15  
EMLA cream Article-30 referral - Annex II SL = slovenščina 2015-01-15  
EMLA cream Article-30 referral - Annex II FI = suomi 2015-01-15  
EMLA cream Article-30 referral - Annex II SV = svenska 2015-01-15  
EMLA cream Article-30 referral - Annex II HR = Hrvatski 2015-01-15  
EMLA cream Article-30 referral - Annex III BG = bălgarski 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III ES = español 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III CS = čeština 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III DA = dansk 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III DE = Deutsch 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III ET = eesti keel 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III EL = elliniká 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III EN = English 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III FR = français 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III IT = italiano 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III LV = latviešu valoda 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III LT = lietuvių kalba 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III HU = magyar 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III MT = Malti 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III NL = Nederlands 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III PL = polski 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III PT = português 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III RO = română 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III SK = slovenčina 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III SL = slovenščina 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III FI = suomi 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III SV = svenska 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III HR = Hrvatski 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III IS = Islenska 2014-09-26 2015-01-15
EMLA cream Article-30 referral - Annex III NO = Norsk 2014-09-26 2015-01-15

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:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

Related information on EMLA cream