Picato® (ingenol mebutate): evaluation of the benefit-risk ratio
2020.05.05
Active substance: ingenol mebutate
05.05.2020 - CHMP opinion
The risks of Picato® for the treatment of actinic keratosis outweigh the benefits
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has completed its review of Picato® with the conclusion that the drug may increase the risk of skin cancer and that the risks outweigh the benefits.
20.04.2020 - Completion of the review - PRAC recommendation
The European Medicines Agency (EMA) concludes the review of Picato® with the result that the risks of the drug outweigh the benefits and the drug is therefore no longer approved.
13.02.2020 - Revocation of the marketing authorisation following an application by the previous marketing authorisation holder
By decision of February 11, 2020, the European Commission revoked the marketing authorization for Picato® (ingenolmebutate) upon request of the previous authorization holder.
20.01.2020 - European Commission decision
With the decision of January 17, 2020 pursuant to Art. 20 of Regulation (EC) No. 726/04, the European Commission has temporarily suspended the approvals. The drugs are no longer marketable.
17.01.2020 - PRAC recommendation
EMA recommended that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.
06.09.2019 - Procedure started
EMA’s safety committee (PRAC) is currently reviewing data on skin cancer in patients using Picato, a gel for treating the skin condition actinic keratosis.
Further information
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
To the risk assessment procedure (available in German only)