Picato

ingenol mebutate

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This is a summary of the European public assessment report (EPAR) for Picato. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Picato.

What is Picato?

Picato is a medicine containing the active substance ingenol mebutate. It is available as a gel in two strengths (150 micrograms/g and 500 micrograms/g).

What is Picato used for?

Picato is used to treat adults with actinic keratosis. Actinic keratosis is a skin lesion that develops after too much exposure to sunlight. Picato is used when the outer layer of the skin affected by actinic keratosis is not thickened or raised.

The medicine can only be obtained with a prescription.

How is Picato used?

Picato gel is applied to the affected skin areas. When the affected areas are the face, scalp and upper part of the neck, Picato (150 micrograms/g) should be applied once a day for three consecutive days. When the affected areas are the trunk, extremities and lower part of the neck, the higher-strength Picato (500 micrograms/g) should be applied once a day for two consecutive days. A new tube of Picato gel should be used for each application. The content of one tube covers a treatment area of 25 cm2.

For further information on how to use Picato see the package leaflet.

The patient’s response to treatment can be assessed approximately eight weeks after treatment.

How does Picato work?

The exact way Picato works is not fully understood. It is thought that the active substance in Picato, ingenol mebutate, works in two different ways. Once applied and absorbed by the skin cells, ingenol mebutate has a direct toxic effect on the cell as well as promoting an inflammatory response. Together, these actions lead to the death of the cells affected by actinic keratosis.

How has Picato been studied?

The effects of Picato were first tested in experimental models before being studied in humans.

Picato (150 microgram/g) has been studied in two main studies involving 547 adults with actinic keratosis affecting the face and scalp, where it was applied once a day for three consecutive days.

Picato (500 microgram/g) has been studied in two studies involving 458 adults with actinic keratosis affecting the trunk and extremities, where it was applied once a day for two consecutive days.

In all four studies, Picato was compared with vehicle (a gel without active substance). The main measure of effectiveness was the number of patients whose skin was completely cleared of the actinic keratosis eight weeks after treatment.

What benefit has Picato shown during the studies?

Picato was shown to be effective in clearing actinic keratosis from the skin.

For actinic keratosis affecting the face and scalp, the first study showed that the skin completely cleared in 47% (67 out of 142) of patients treated with Picato, compared with 5% (7 out of 136) of patients treated with placebo. In the second study the skin completely cleared in 37% (50 out of 135) of patients treated with Picato, compared with 2% (3 out of 134) of patients treated with placebo.

For actinic keratosis of the trunk and extremities, the first study showed that the skin cleared completely in 28% (35 out of 126) of patients treated with Picato, compared with 5% (6 out of 129) of patients treated with placebo. In the second study, the skin cleared in 42% (42 out of 100) of patients treated with Picato, compared with 5% (5 out of 103) of patients treated with placebo.

What is the risk associated with Picato?

The most frequently reported side effects are skin reactions at the application site of Picato, including erythema (reddening of the skin), flaking or scaling, crusting, swelling, vesiculation or pustulation (blisters), and erosion or ulceration (wearing away of outer skin layer or open sore of the skin). Following the application of Picato, most patients (more than 95%) experienced one or more local skin responses. Infection at the application site was also reported when treating the face and scalp.

For the full list of all side effects reported with Picato, see the package leaflet.
Picato must not be used in people who are hypersensitive (allergic) to ingenol mebutate or any of the other ingredients.

Why has Picato been approved?

The CHMP noted that treatment with Picato has a beneficial effect. There were no major safety concerns with Picato and the side effects seen were mostly local skin reactions which, although they affected most patients, usually resolved within two to four weeks of treatment depending on the location. In addition, the CHMP considered the fact that Picato can be self-applied and that treatment is of short duration as an advantage. The CHMP therefore decided that Picato’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Picato

The European Commission granted a marketing authorisation valid throughout the European Union for Picato on 15 November 2012.

For more information about treatment with Picato, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Picato : EPAR - Summary for the public BG = bălgarski 2012-11-29  
Picato : EPAR - Summary for the public ES = español 2012-11-29  
Picato : EPAR - Summary for the public CS = čeština 2012-11-29  
Picato : EPAR - Summary for the public DA = dansk 2012-11-29  
Picato : EPAR - Summary for the public DE = Deutsch 2012-11-29  
Picato : EPAR - Summary for the public ET = eesti keel 2012-11-29  
Picato : EPAR - Summary for the public EL = elliniká 2012-11-29  
Picato : EPAR - Summary for the public EN = English 2012-11-29  
Picato : EPAR - Summary for the public FR = français 2012-11-29  
Picato : EPAR - Summary for the public IT = italiano 2012-11-29  
Picato : EPAR - Summary for the public LV = latviešu valoda 2012-11-29  
Picato : EPAR - Summary for the public LT = lietuvių kalba 2012-11-29  
Picato : EPAR - Summary for the public HU = magyar 2012-11-29  
Picato : EPAR - Summary for the public MT = Malti 2012-11-29  
Picato : EPAR - Summary for the public NL = Nederlands 2012-11-29  
Picato : EPAR - Summary for the public PL = polski 2012-11-29  
Picato : EPAR - Summary for the public PT = português 2012-11-29  
Picato : EPAR - Summary for the public RO = română 2012-11-29  
Picato : EPAR - Summary for the public SK = slovenčina 2012-11-29  
Picato : EPAR - Summary for the public SL = slovenščina 2012-11-29  
Picato : EPAR - Summary for the public FI = suomi 2012-11-29  
Picato : EPAR - Summary for the public SV = svenska 2012-11-29  

This EPAR was last updated on 13/03/2017 .

Authorisation details

Product details

Product details for Picato
NamePicato
Agency product numberEMEA/H/C/002275
Active substance

ingenol mebutate

International non-proprietary name (INN) or common name

ingenol mebutate

Therapeutic area Keratosis, Actinic
Anatomical therapeutic chemical (ATC) code D06BX02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Picato
Marketing-authorisation holder

LEO Laboratories Ltd.

Revision5
Date of issue of marketing authorisation valid throughout the European Union15/11/2012

Contact address:

LEO Laboratories Ltd.
285 Cashel Road
Crumlin, Dublin 12
Ireland

Product information

Product information

26/01/2017  Picato -EMEA/H/C/002275 -T/0022

Name Language First published Last updated
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13
Picato : EPAR - Product Information SV = svenska 2012-11-29 2017-03-13

Contents

  • 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.


Name Language First published Last updated
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  
Picato : EPAR - All Authorised presentations SV = svenska 2012-11-29  

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

Initial marketing-authorisation documents

Name Language First published Last updated
Picato : EPAR - Public assessment report SV = svenska 2012-11-29  
CHMP summary of positive opinion for Picato SV = svenska 2012-09-21  

Authorised

This medicine is approved for use in the European Union