Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: LEO Laboratories Ltd., 285 Cashel Road, Crumlin, Dublin 12, Ireland
Picato 150 micrograms/gram gel.
| Pharmaceutical Form |
|---|
|
Gel. Clear colourless gel. |
Each gram of gel contains 150 mcg of ingenol mebutate. Each tube contains 70 mcg of ingenol mebutate in 0.47 g of gel.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ingenol mebutate |
Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults. The mechanism of action of ingenol mebutate for use in actinic keratosis remains to be fully characterised. Results from two clinical studies on biological effects of ingenol mebutate have shown that topical administration induced epidermal necrosis and a profound inflammatory response in both epidermis and the upper dermis of the treated skin, dominated by infiltrating T cells, neutrophils and macrophages. |
| List of Excipients |
|---|
|
Isopropyl alcohol |
Single-dose laminate tubes with inner layer of High Density Polyethylene (HDPE) and aluminium as the barrier layer. Caps of HDPE.
Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 g of gel each
LEO Laboratories Ltd., 285 Cashel Road, Crumlin, Dublin 12, Ireland
EU/1/12/796/001
Date of first authorisation: 15 November 2012
Date of latest renewal: 13 July 2017
| Drug | Countries | |
|---|---|---|
| PICATO | Brazil, Estonia, Lithuania, Poland, Romania, United States |
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