Picato
Withdrawn
This medicine's authorisation has been withdrawn
ingenol mebutate
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 11 February 2020, the European Commission withdrew the marketing authorisation for Picato (ingenol mebutate) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, LEO Laboratories Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Picato was granted marketing authorisation in the EU on 15 November 2012 for treatment of actinic keratosis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017. This withdrawal is without prejudice to the outcome of the pending referral procedure on Picato under Article 20 of Regulation (EC) No 726/2004.
The European Public Assessment Report (EPAR) for Picato is updated to indicate that the marketing authorisation is no longer valid.
Picato : EPAR - Summary for the public
Reference Number: EMA/617430/2012
English (EN) (634.16 KB - PDF)
First published: Last updated:
български (BG) (726.46 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
español (ES) (634.22 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
čeština (CS) (707.34 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
dansk (DA) (633.58 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Deutsch (DE) (633.57 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
eesti keel (ET) (661.82 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
ελληνικά (EL) (750.88 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
français (FR) (633.85 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
italiano (IT) (655.63 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
latviešu valoda (LV) (767.69 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
lietuvių kalba (LT) (656 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
magyar (HU) (701.4 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Malti (MT) (705.58 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Nederlands (NL) (632.99 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
polski (PL) (705.79 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
português (PT) (634.36 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
română (RO) (656.13 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
slovenčina (SK) (706.78 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
slovenščina (SL) (713.32 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Suomi (FI) (637.57 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
svenska (SV) (633.06 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Picato : EPAR - Risk-management-plan summary
English (EN) (3.71 MB - PDF)
First published: Last updated:
Product information
Picato : EPAR - Product Information
English (EN) (1.28 MB - PDF)
First published: Last updated:
български (BG) (1.87 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
español (ES) (1.21 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
čeština (CS) (2.02 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
dansk (DA) (1.12 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Deutsch (DE) (1.26 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
eesti keel (ET) (984.23 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
ελληνικά (EL) (2.83 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
français (FR) (1.06 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
hrvatski (HR) (1.2 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
íslenska (IS) (1.12 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
italiano (IT) (1.06 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
latviešu valoda (LV) (2.05 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
lietuvių kalba (LT) (1.39 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
magyar (HU) (2.19 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Malti (MT) (2.07 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Nederlands (NL) (1.16 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
norsk (NO) (1.15 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
polski (PL) (2.09 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
português (PT) (1.18 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
română (RO) (1.16 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
slovenčina (SK) (2.16 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
slovenščina (SL) (1.98 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Suomi (FI) (1.14 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
svenska (SV) (1.17 MB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Latest procedure affecting product information:
A-20/1489/C/002275/0030
02/07/2020
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).
Picato : EPAR - All Authorised presentations
English (EN) (585.06 KB - PDF)
First published: Last updated:
български (BG) (628.12 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
español (ES) (575.7 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
čeština (CS) (620.7 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
dansk (DA) (575.58 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Deutsch (DE) (573.11 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
eesti keel (ET) (577.13 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
ελληνικά (EL) (627.44 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
français (FR) (575.64 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
hrvatski (HR) (612.48 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
íslenska (IS) (577.1 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
italiano (IT) (577.14 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
latviešu valoda (LV) (622.94 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
lietuvių kalba (LT) (605.06 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
magyar (HU) (619.9 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Malti (MT) (621.67 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Nederlands (NL) (575.78 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
norsk (NO) (575.77 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
polski (PL) (619.55 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
português (PT) (575.7 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
română (RO) (602.5 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
slovenčina (SK) (606.88 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
slovenščina (SL) (592.5 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Suomi (FI) (575.96 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
svenska (SV) (574.66 KB - PDF)
First published: 29/11/2012Last updated: 04/03/2020
Product details
- Name of medicine
- Picato
- 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
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.
Authorisation details
- EMA product number
- EMEA/H/C/002275
- Marketing authorisation holder
- LEO Laboratories Ltd.
285 Cashel Road
Crumlin, Dublin 12
Ireland - Marketing authorisation issued
- 15/11/2012
- Revision
- 10
Assessment history
Picato : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (752.53 KB - PDF)
First published: Last updated:
Picato-H-A-20-1489-C-002275-0030 : EPAR - Scientific conclusions - Article 20
Adopted
English (EN) (668.3 KB - PDF)
First published:
български (BG) (715.5 KB - PDF)
First published: 31/07/2020
español (ES) (668.37 KB - PDF)
First published: 31/07/2020
čeština (CS) (710.11 KB - PDF)
First published: 31/07/2020
dansk (DA) (667.4 KB - PDF)
First published: 31/07/2020
Deutsch (DE) (675.55 KB - PDF)
First published: 31/07/2020
eesti keel (ET) (665.66 KB - PDF)
First published: 31/07/2020
ελληνικά (EL) (724.03 KB - PDF)
First published: 31/07/2020
français (FR) (670.08 KB - PDF)
First published: 31/07/2020
hrvatski (HR) (700.32 KB - PDF)
First published: 31/07/2020
italiano (IT) (666.2 KB - PDF)
First published: 31/07/2020
latviešu valoda (LV) (727.44 KB - PDF)
First published: 31/07/2020
lietuvių kalba (LT) (699.38 KB - PDF)
First published: 31/07/2020
magyar (HU) (707.95 KB - PDF)
First published: 31/07/2020
Malti (MT) (729.72 KB - PDF)
First published: 31/07/2020
Nederlands (NL) (669.75 KB - PDF)
First published: 31/07/2020
polski (PL) (704.58 KB - PDF)
First published: 31/07/2020
português (PT) (677.54 KB - PDF)
First published: 31/07/2020
română (RO) (695.64 KB - PDF)
First published: 31/07/2020
slovenčina (SK) (708.63 KB - PDF)
First published: 31/07/2020
slovenščina (SL) (721.98 KB - PDF)
First published: 31/07/2020
Suomi (FI) (663.62 KB - PDF)
First published: 31/07/2020
svenska (SV) (669.5 KB - PDF)
First published: 31/07/2020
Picato-H-A-20-1489-C-002275-0030 : EPAR - Assessment report - Article 20
AdoptedReference Number: EMA/248352/2020
English (EN) (2.46 MB - PDF)
First published:
Picato-H-C-PSUSA-00010035-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/CHMP/562130/2019
English (EN) (670.49 KB - PDF)
First published: Last updated:
Picato-H-C-PSUSA-00010035-201807 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/CHMP/224971/2019
English (EN) (678.25 KB - PDF)
First published: Last updated:
Picato-H-C-PSUSA-00010035-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/312676/2017
English (EN) (650.82 KB - PDF)
First published: Last updated:
Picato-H-C-PSUSA-00010035-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/267380/2016
English (EN) (625.16 KB - PDF)
First published: Last updated:
News on Picato
More information on Picato
Picato Article-20 referral - Assessment report on provisional measures
AdoptedReference Number: EMA/30347/2020
English (EN) (3.17 MB - PDF)
First published: Last updated:
More information on Picato
This page was last updated on