Picato

Withdrawn

This medicine's authorisation has been withdrawn

ingenol mebutate

Overview

The marketing authorisation for Picato has been withdrawn at the request of the marketing-authorisation holder.

Picato : EPAR - Summary for the public

Reference Number: EMA/617430/2012

Picato : EPAR - Risk-management-plan summary

Product information

Picato : EPAR - Product Information

Latest procedure affecting product information: A-20/1489/C/002275/0030

02/07/2020

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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

AdoptedReference 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

AdoptedReference 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

AdoptedReference 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

AdoptedReference 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

AdoptedReference Number: EMA/CHMP/553672/2012