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| The United Kingdom: Class 2 Medicines Recall: Esmya 5mg tablets (English only) |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that Gedeon Richter (UK) Ltd is recalling all unexpired stock of Esmya 5mg tablets from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine. To protect patients while a safety review is conducted, the European Medicines Agency’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), has recommended that women stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids.
This recall does not affect the 30mg single dose ulipristal acetate emergency contraceptive products.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-esmya-5mg-tablets-eu-1-12-750-001-5-el-20-a-16
In Hong Kong, Esmya (ulipristal acetate) Tablets 5mg (HK-62553) is a pharmaceutical product registered by Orient Europharma Co. Ltd (Orient Europharma), and is a prescription-only medicine. The Department of Health (DH) has contacted Orient Europharma to follow up on the local impact by the incident, and reply is pending. The DH will continue to follow up with Orient Europharma for consideration of any action deemed necessary.
Related news on the recent review of Esmya was previously issued by the European Medicines Agency, and was posted on the Drug Office website on 14 Mar 2020.
Ends/Thursday, Mar 19, 2020
Issued at HKT 17:30
On 20 Mar 2020, the Department of Health (DH) endorsed Orient Europharma Co. Ltd to voluntarily recall Esmya Tablets 5mg (HK-62553) from patients due to the potential risk of liver injury. The DH will continue to monitor the recall.
Content last updated: Friday, Mar 20, 2020
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