🇪🇺 Ingenol mebutate gel 0.05 % in European Union

EMA authorised Ingenol mebutate gel 0.05 % on 15 November 2012

Marketing authorisation

EMA — authorised 15 November 2012

  • Application: EMEA/H/C/002275
  • Marketing authorisation holder: LEO Laboratories Ltd.
  • Local brand name: Picato
  • Indication: Picato is indicated for the cutaneous treatment of non?hyperkeratotic, non?hypertrophic actinic keratosis in adults.
  • Status: withdrawn

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Ingenol mebutate gel 0.05 % in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Dermatology approved in European Union

Frequently asked questions

Is Ingenol mebutate gel 0.05 % approved in European Union?

Yes. EMA authorised it on 15 November 2012.

Who is the marketing authorisation holder for Ingenol mebutate gel 0.05 % in European Union?

LEO Laboratories Ltd. holds the EU marketing authorisation.