Picato

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
Procedure started

Overview

Review of data on skin cancer with Picato

EMA is reviewing data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure.

The review was triggered by data from several studies showing a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using Picato.

The product information for Picato already contains a warning about reports of one type of skin tumour (keratoacanthoma) and, following a separate review, this warning is currently being updated to mention skin cancers called basal cell carcinoma, Bowen’s disease and squamous cell carcinoma.

Healthcare professionals are advised to use Picato with caution in patients who have had skin cancer in the past. In addition, patients should continue to watch out for any skin lesions and inform their doctor immediately if they notice anything unusual. Patients who have questions or concerns about their treatment should contact their doctor.

In order to conclude on whether Picato increases the risk of skin cancer, the EMA’s safety committee (PRAC) will now carry out a thorough review of all available data, including from ongoing studies. The Committee will assess the impact of the data on the benefit-risk balance of Picato and recommend whether the medicine’s marketing authorisation in the EU should be amended.

Key facts

About this medicine
Approved name
Picato
International non-proprietary name (INN) or common name

ingenol mebutate

Associated names
Picato
About this procedure
Current status
Procedure started
Reference number
EMEA/H/A-20/1489/C/2275/1489
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
05/09/2019

All documents

Procedure started

Document description

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the CHMP or CMDh
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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