Picato

ingenol mebutate

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Patient safety

Patient safety information

Overview

The marketing authorisation for Picato has been withdrawn at the request of the marketing-authorisation holder.

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
- Bulgarian
  (PDF/726.46 KB)
- Czech
  (PDF/707.34 KB)
- Danish
  (PDF/633.58 KB)
- Dutch
  (PDF/632.99 KB)
- Estonian
  (PDF/661.82 KB)
- Finnish
  (PDF/637.57 KB)
- French
  (PDF/633.85 KB)
- German
  (PDF/633.57 KB)
- Greek
  (PDF/750.88 KB)
- Hungarian
  (PDF/701.4 KB)
- Italian
  (PDF/655.63 KB)
- Latvian
  (PDF/767.69 KB)
- Lithuanian
  (PDF/656 KB)
- Maltese
  (PDF/705.58 KB)
- Polish
  (PDF/705.79 KB)
- Portuguese
  (PDF/634.36 KB)
- Romanian
  (PDF/656.13 KB)
- Slovak
  (PDF/706.78 KB)
- Slovenian
  (PDF/713.32 KB)
- Spanish
  (PDF/634.22 KB)
- Swedish
  (PDF/633.06 KB)
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Picato : EPAR - Risk-management-plan summary (PDF/3.71 MB)

First published: 13/05/2019
Last updated: 04/03/2020

More detail is available in the summary of product characteristics

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 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

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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.

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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.

Assessment history

Changes since initial authorisation of medicine

List item

Picato : EPAR - Procedural steps taken and scientific information after authorisation (PDF/752.53 KB)

First published: 17/01/2014
Last updated: 31/07/2020
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Picato-H-A-20-1489-C-002275-0030 : EPAR - Scientific conclusions - Article 20 (PDF/668.3 KB)

Adopted

First published: 31/07/2020
- Bulgarian
  (PDF/715.5 KB)
- Croatian
  (PDF/700.32 KB)
- Czech
  (PDF/710.11 KB)
- Danish
  (PDF/667.4 KB)
- Dutch
  (PDF/669.75 KB)
- Estonian
  (PDF/665.66 KB)
- Finnish
  (PDF/663.62 KB)
- French
  (PDF/670.08 KB)
- German
  (PDF/675.55 KB)
- Greek
  (PDF/724.03 KB)
- Hungarian
  (PDF/707.95 KB)
- Italian
  (PDF/666.2 KB)
- Latvian
  (PDF/727.44 KB)
- Lithuanian
  (PDF/699.38 KB)
- Maltese
  (PDF/729.72 KB)
- Polish
  (PDF/704.58 KB)
- Portuguese
  (PDF/677.54 KB)
- Romanian
  (PDF/695.64 KB)
- Slovak
  (PDF/708.63 KB)
- Slovenian
  (PDF/721.98 KB)
- Spanish
  (PDF/668.37 KB)
- Swedish
  (PDF/669.5 KB)
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Picato-H-A-20-1489-C-002275-0030 : EPAR - Assessment report - Article 20 (PDF/2.46 MB)

Adopted

First published: 08/07/2020
EMA/248352/2020
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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)

Adopted

First published: 15/11/2019
Last updated: 04/03/2020
EMA/CHMP/562130/2019
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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)

Adopted

First published: 13/05/2019
Last updated: 04/03/2020
EMA/CHMP/224971/2019
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Picato-H-C-PSUSA-00010035-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/650.82 KB)

Adopted

First published: 16/05/2017
Last updated: 04/03/2020
EMA/312676/2017
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Picato-H-C-PSUSA-00010035-201601 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/626.05 KB)

Adopted

First published: 22/11/2016
Last updated: 04/03/2020
EMA/761522/2016
List item

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)

First published: 27/04/2016
Last updated: 04/03/2020
EMA/267380/2016

Initial marketing-authorisation documents

Patient Safety

Risks of Picato for actinic keratosis outweigh benefits

30/04/2020

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/752.53 KB)

Picato-H-A-20-1489-C-002275-0030 : EPAR - Scientific conclusions - Article 20 (PDF/668.3 KB)

Picato-H-A-20-1489-C-002275-0030 : EPAR - Assessment report - Article 20 (PDF/2.46 MB)

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-H-C-PSUSA-00010035-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (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 (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

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)

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