Picato
Withdrawn
This medicine's authorisation has been withdrawn
ingenol mebutate
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Picato has been withdrawn at the request of the marketing-authorisation holder.
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:
Public statement on Picato: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/91080/2020
English (EN) (118.58 KB - PDF)
First published:
More information on Picato
Topics
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