Picato LEO Laboratories Ltd. · Withdrawn · authorised 15 Nov 2012 · ATC D06BX02
Therapeutic indication (EMA)
Picato is indicated for the cutaneous treatment of non?hyperkeratotic, non?hypertrophic actinic keratosis in adults.
Active substance
Ingenol mebutate
- US FDA 3
- EMA 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PICATO | 0.015%; 0.05% | gel · topical | LEO LABS | Discontinued | 23 Jan 2012 |
| INGENOL MEBUTATE | 0.015% | gel · topical | PADAGIS ISRAEL | Discontinued | 7 Jan 2019 |
| INGENOL MEBUTATE | 0.05% | gel · topical | PADAGIS ISRAEL | Discontinued | 9 Jan 2019 |
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 19 Mar 2021 PICATO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.