Picato

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ingenol mebutate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Picato. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Picato.

This EPAR was last updated on 16/08/2017

Authorisation details

Product details
Name
Picato
Agency product number
EMEA/H/C/002275
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
Publication details
Marketing-authorisation holder
LEO Laboratories Ltd.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
14/11/2012
Contact address
285 Cashel Road
Crumlin, Dublin 12
Ireland

Product information

13/07/2017 Picato - EMEA/H/C/002275 - R/0023

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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