Picato
ingenol mebutate
Table of contents
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The marketing authorisation for Picato has been withdrawn at the request of the marketing-authorisation holder.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
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 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
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Antibiotics and chemotherapeutics for dermatological use
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Other chemotherapeutics
Therapeutic indication
Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.