Discontinuation report PICATO
| Report ID | 127352 |
| Drug Identification Number | 02400987 |
| Brand name | PICATO |
| Common or Proper name | Ingenol mebutate |
| Company Name | LEO PHARMA INC |
| Market Status | CANCELLED POST MARKET |
| Active Ingredient(s) | INGENOL MEBUTATE |
| Strength(s) | 0.015% |
| Dosage form(s) | GEL |
| Route of administration | TOPICAL TOPICAL |
| Packaging size | 3 x 0.47g |
| ATC code | D06BX |
| ATC description | CHEMOTHERAPEUTICS FOR TOPICAL USE |
| Reason for discontinuation | Other (Please describe in comments) |
| Anticipated discontinuation date | |
| Actual discontinuation date | 2020-10-14 |
| Remaining supply date | 2020-12-11 |
| Discontinuation status | Discontinued |
| Discontinuation decision reversal | No |
| Information on remaining supply | On October 26, 2020, LEO Pharma Inc. initiated the recall of PICATO from the Canadian market. |
| Company comments | On October 14, 2020, Health Canada directed LEO Pharma Inc. to stop the sale of PICATO at the manufacturer level. |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | 3389 STEELES AVENUE EAST, SUITE 110 TORONTO, ONTARIO CANADA M2H 3S8 |
| Company contact information |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v4 | 2020-10-28 | French | Compare |
| v3 | 2020-10-28 | English | Compare |
| v2 | 2020-10-28 | English | Compare |
| v1 | 2020-10-28 | English | Compare |
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