Picato
ingenol mebutate
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Patient safety
Overview
The marketing authorisation for Picato has been withdrawn at the request of the marketing-authorisation holder.
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List item
Picato : EPAR - Summary for the public (PDF/634.16 KB)
First published: 29/11/2012
Last updated: 04/03/2020
EMA/617430/2012 -
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List item
Picato : EPAR - Risk-management-plan summary (PDF/3.71 MB)
First published: 13/05/2019
Last updated: 04/03/2020
This EPAR was last updated on 31/07/2020
Authorisation details
Product details | |
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Name |
Picato
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Agency product number |
EMEA/H/C/002275
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Active substance |
Ingenol mebutate
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International non-proprietary name (INN) or common name |
ingenol mebutate
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Therapeutic area (MeSH) |
Keratosis, Actinic
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Anatomical therapeutic chemical (ATC) code |
D06BX02
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Additional 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 | |
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Marketing-authorisation holder |
LEO Laboratories Ltd.
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Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
15/11/2012
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Contact address |
Product information
02/07/2020 Picato - EMEA/H/C/002275 - A-20/1489/C/002275/0030
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
Pharmacotherapeutic group
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Antibiotics and chemotherapeutics for dermatological use
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Other chemotherapeutics
Therapeutic indication
Therapeutic indication
Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.