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| The United Kingdom: Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 mcg／g gel▼ and Picato 500 mcg／g gel▼ (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of Picato 150 mcg/g gel▼ and Picato 500 mcg/g gel▼ from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy. The recall is a precautionary measure following the suspension of the marketing authorisation of Picato (ingenol mebutate), while investigations are ongoing.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-leo-laboratories-ltd-picato-150-mcg-g-gel-eu-1-12-796-001-picato-500-mcg-g-gel-eu-1-12-796-002-el-20-a-02
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by MHRA and European Medicines Agency, and was posted on the Drug Office website on 19 Oct 2019 and 18 Jan 2020.
Ends/Wednesday, Jan 29, 2020
Issued at HKT 16:00
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