Picato

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	9
Date of issue of marketing authorisation valid throughout the European Union	15/11/2012
Contact address	285 Cashel Road Crumlin, Dublin 12 Ireland

11/11/2019 Picato - EMEA/H/C/002275 - PSUSA/00010035/201901

List item

Picato : EPAR - Product Information (PDF/1.28 MB)

First published: 29/11/2012
Last updated: 04/03/2020
- Bulgarian
  (PDF/1.87 MB)
- Croatian
  (PDF/1.2 MB)
- Czech
  (PDF/2.02 MB)
- Danish
  (PDF/1.12 MB)
- Dutch
  (PDF/1.16 MB)
- Estonian
  (PDF/984.23 KB)
- Finnish
  (PDF/1.14 MB)
- French
  (PDF/1.06 MB)
- German
  (PDF/1.26 MB)
- Greek
  (PDF/2.83 MB)
- Hungarian
  (PDF/2.19 MB)
- Icelandic
  (PDF/1.12 MB)
- Italian
  (PDF/1.06 MB)
- Latvian
  (PDF/2.05 MB)
- Lithuanian
  (PDF/1.39 MB)
- Maltese
  (PDF/2.07 MB)
- Norwegian
  (PDF/1.15 MB)
- Polish
  (PDF/2.09 MB)
- Portuguese
  (PDF/1.18 MB)
- Romanian
  (PDF/1.16 MB)
- Slovak
  (PDF/2.16 MB)
- Slovenian
  (PDF/1.98 MB)
- Spanish
  (PDF/1.21 MB)
- Swedish
  (PDF/1.17 MB)

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.

List item

Picato : EPAR - All Authorised presentations (PDF/585.06 KB)

First published: 29/11/2012
Last updated: 04/03/2020
- Bulgarian
  (PDF/628.12 KB)
- Croatian
  (PDF/612.48 KB)
- Czech
  (PDF/620.7 KB)
- Danish
  (PDF/575.58 KB)
- Dutch
  (PDF/575.78 KB)
- Estonian
  (PDF/577.13 KB)
- Finnish
  (PDF/575.96 KB)
- French
  (PDF/575.64 KB)
- German
  (PDF/573.11 KB)
- Greek
  (PDF/627.44 KB)
- Hungarian
  (PDF/619.9 KB)
- Icelandic
  (PDF/577.1 KB)
- Italian
  (PDF/577.14 KB)
- Latvian
  (PDF/622.94 KB)
- Lithuanian
  (PDF/605.06 KB)
- Maltese
  (PDF/621.67 KB)
- Norwegian
  (PDF/575.77 KB)
- Polish
  (PDF/619.55 KB)
- Portuguese
  (PDF/575.7 KB)
- Romanian
  (PDF/602.5 KB)
- Slovak
  (PDF/606.88 KB)
- Slovenian
  (PDF/592.5 KB)
- Spanish
  (PDF/575.7 KB)
- Swedish
  (PDF/574.66 KB)

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.

Table of contents

Overview

Picato : EPAR - Summary for the public (PDF/634.16 KB)

Picato : EPAR - Risk-management-plan summary (PDF/3.71 MB)

Authorisation details

Product information

Picato : EPAR - Product Information (PDF/1.28 MB)

Contents

Picato : EPAR - All Authorised presentations (PDF/585.06 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Picato : EPAR - Procedural steps taken and scientific information after authorisation (PDF/711.92 KB)

Picato-H-C-PSUSA-00010035-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/670.49 KB)

Picato-H-C-PSUSA-00010035-201807 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/678.25 KB)

Picato : EPAR - Scientific Conclusion (PDF/650.82 KB)

Picato-H-C-PSUSA-00010035/201601 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/626.05 KB)

Picato-H-C-PSUSA-00010035-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/625.16 KB)

Initial marketing-authorisation documents

Picato : EPAR - Public assessment report (PDF/3.75 MB)

CHMP summary of positive opinion for Picato (PDF/605.85 KB)

Patient Safety

News

More information on Picato

Picato Article-20 referral - Assessment report on provisional measures (PDF/3.17 MB)

Public statement on Picato: Withdrawal of the marketing authorisation in the European Union (PDF/118.58 KB)

How useful was this page?

Picato

Table of contents

Overview

Picato : EPAR - Summary for the public (PDF/634.16 KB)

Picato : EPAR - Risk-management-plan summary (PDF/3.71 MB)

Authorisation details

Product information

Picato : EPAR - Product Information (PDF/1.28 MB)

Contents

Picato : EPAR - All Authorised presentations (PDF/585.06 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Picato : EPAR - Procedural steps taken and scientific information after authorisation (PDF/711.92 KB)

Picato-H-C-PSUSA-00010035-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/670.49 KB)

Picato-H-C-PSUSA-00010035-201807 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/678.25 KB)

Picato : EPAR - Scientific Conclusion (PDF/650.82 KB)

Picato-H-C-PSUSA-00010035/201601 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/626.05 KB)

Picato-H-C-PSUSA-00010035-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/625.16 KB)

Initial marketing-authorisation documents

Picato : EPAR - Public assessment report (PDF/3.75 MB)

CHMP summary of positive opinion for Picato (PDF/605.85 KB)

Patient Safety

News

More information on Picato

Picato Article-20 referral - Assessment report on provisional measures (PDF/3.17 MB)

Public statement on Picato: Withdrawal of the marketing authorisation in the European Union (PDF/118.58 KB)

Related content

How useful was this page?