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Medicine recalls

 
The United Kingdom: Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 mcg/g gel▼ and Picato 500 mcg/g gel▼
 
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
 
Related Information:
Canada: Leo Pharma Canada Inc. Product Recall Posted 2020-11-04
Canada: PICATO (ingenol mebutate gel, 0.015% and 0.05%): Product withdrawal in C... Posted 2020-10-28
Canada: Summary Safety Review: Picato (ingenol mebutate): Assessing the Potentia... Posted 2020-07-03
European Union: Risks of Picato for actinic keratosis outweigh benefits Posted 2020-05-02
European Union: EMA review of Picato concludes medicine’s risks outweigh its ben... Posted 2020-04-18
The United Kingdom: Ingenol mebutate gel (Picato▼): suspension of the licence du... Posted 2020-02-13
European Union: EMA suspends Picato as a precaution while review of skin cancer ... Posted 2020-01-18
The United Kingdom: Ingenol mebutate gel (Picato): increased incidence of skin t... Posted 2019-10-19
 
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