Picato

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ingenol mebutate

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Picato has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 31/07/2020

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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
LEO Laboratories Ltd.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
15/11/2012
Contact address
285 Cashel Road
Crumlin, Dublin 12
Ireland

Product information

02/07/2020 Picato - EMEA/H/C/002275 - A-20/1489/C/002275/0030

Contents

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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

Changes since initial authorisation of medicine

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