Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use

EMLA cream and associated names

Product name: EMLA cream and associated names
Active substance: lidocaine/prilocaine
Indication: EMLA Cream is indicated for:
• Topical anaesthesia of the skin in connection with:
- needle insertion, e.g. intravenous catheters or blood sampling;
- superficial surgical procedures;
in adults and in the paediatric population
• Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia; in adults and adolescents ≥12 years
• Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/12/2014 Referral EMEA/H/A-30/1388 (2014)9276 of 28/11/2014