Picato

Withdrawn

This medicine's authorisation has been withdrawn

ingenol mebutate

Overview

On 11 February 2020, the European Commission withdrew the marketing authorisation for Picato (ingenol mebutate) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, LEO Laboratories Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Picato was granted marketing authorisation in the EU on 15 November 2012 for treatment of actinic keratosis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017. This withdrawal is without prejudice to the outcome of the pending referral procedure on Picato under Article 20 of Regulation (EC) No 726/2004. 

The European Public Assessment Report (EPAR) for Picato is updated to indicate that the marketing authorisation is no longer valid.

Picato : EPAR - Summary for the public

Reference Number: EMA/617430/2012

Picato : EPAR - Risk-management-plan summary

Product information

Picato : EPAR - Product Information

Picato : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Picato
• Active substance:
  Ingenol mebutate
• International non-proprietary name (INN) or common name:
  ingenol mebutate
• Therapeutic area (MeSH):
  Keratosis, Actinic
• Anatomical therapeutic chemical (ATC) code:
  D06BX02

Pharmacotherapeutic group

• Antibiotics and chemotherapeutics for dermatological use
• Other chemotherapeutics

Therapeutic indication

Picato is indicated for the cutaneous treatment of non?hyperkeratotic, non?hypertrophic actinic keratosis in adults.

Authorisation details

• EMA product number:
  EMEA/H/C/002275
• Marketing authorisation holder:
  LEO Laboratories Ltd.

  285 Cashel Road; Crumlin, Dublin 12; Ireland

• Marketing authorisation issued:
  15/11/2012
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Picato : EPAR - Procedural steps taken and scientific information after authorisation

Picato-H-A-20-1489-C-002275-0030 : EPAR - Scientific conclusions - Article 20

Adopted

Picato-H-A-20-1489-C-002275-0030 : EPAR - Assessment report - Article 20

Adopted Reference Number: EMA/248352/2020

Picato-H-C-PSUSA-00010035-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/CHMP/562130/2019

Picato-H-C-PSUSA-00010035-201807 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/CHMP/224971/2019

Picato-H-C-PSUSA-00010035-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/312676/2017

Picato-H-C-PSUSA-00010035-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/267380/2016

Initial marketing authorisation documents

Picato : EPAR - Public assessment report

Reference Number: EMA/650464/2012

CHMP summary of positive opinion for Picato

Adopted Reference Number: EMA/CHMP/553672/2012