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Detecting some drugs to treat cancer, arthritis suspected fake drugs

The Drug Administration of Vietnam, the Ministry of Health, said that it had just discovered some samples of drugs labeled Stivarga, Xarelto and Actemra suspected of being fake drugs being sold on the market.

It is known that the drug Stivarga has the active ingredient regorafenib, commonly used in the treatment of rectal and colorectal cancer. Xarelto contains the active ingredient rivaroxaban, which is used to prevent or treat deep vein thrombosis. Actemra is used alone or with other drugs in the treatment of moderate to severe rheumatoid arthritis in adults.

In a document released on March 24, the Drug Administration of Information received information from T&G Law Firm (authorized by Bayer Intellecture Property GmbH) reporting on the detection of suspicious product samples. is a fake drug, on the label it says:

Product name: Stivarga 40mg (film kapli tablet, Regorafenib) Bayer Türk Kimya San. Ltd. Şti Parti No.: BXJL3D1 Son Kull. Ta.: 04.2024.

Product name: Xarelto 10mg (film kapli tablet, Rivaroksaban) Bayer Türk Kimya San. Ltd. Şti; Parti No.: 9LB04017 Son Kull. Ta.: 04/2022.

Product name: Xarelto 15mg (film kapli tablet, Rivaroksaban) Bayer Türk Kimya San. Ltd. Şti; Parti No.: BLB02500 Son Kull. Ta.: 03/2024.

Product name: Xarelto 20mg (film kapli tablet, Rivaroksaban) Bayer Türk Kimya San. Ltd. Şti; Parti No.: ALB08020 Son Kull. Ta.: 11/2023.

Samples of suspected counterfeit drugs were found on the market and some websites (https://healthyungthu.com, https://nhathuoclp.com, https://thuocdactrigan.com). According to the Company’s report and compared with the drug samples provided by T&G Law Firm, the above products have signs of difference compared to the drug samples manufactured by Bayer AG, Bayer Vietnam Co., Ltd or Chi branch of Zuellig Pharma Vietnam Co., Ltd. imports and distributes.

In order to ensure the safety of users, the Drug Administration of Vietnam recommends that the Departments of Health of the provinces and cities, the Health Departments and Bayer AG notify business and drug use establishments about the characteristics and distinguishing signs. between a suspected counterfeit product and a drug manufactured by Bayer AG, imported by Bayer Vietnam Co., Ltd. or a branch of Zuellig Pharma Vietnam Co., Ltd.

At the same time, coordinate information to drug dealers and users and the people to know so as not to trade and use counterfeit products. The Drug Administration also requires the manufacturer of Bayer AG or the drug registration facility Stivarga 40mg, Xarelto 10mg, Xarelto 15mg, Xarelto 20mg to provide relevant documents and documents and promptly report directly to the Department.

At the announcement on March 25, the Drug Administration of Vietnam said that it had received letters from the representative office of the Swiss company F. Hoffmann-La Roche Ltd in Hanoi, with information about the detection of suspected product samples. suspected counterfeit drug, on the label: Actemra 400 mg/20 mL, 400 mg/20 mL, batch number B2101B32.

The product sample provided by the customer (purchased from the website: https://alomuathuoc.vn/san-pham/thuoc-actemra-400mg-20ml-gia/), has been compared by F. Hoffmann-La Roche Ltd. compare, compare and confirm that there are signs that are different from the sample batch of Actemra 400 mg/20 mL, batch number B2101B32 distributed by F. Hoffmann-La Roche Ltd and circulated only in Turkey.

F. Hoffmann-La Roche Ltd Company is the owner of Actemra drugs, including Actemra 200mg/ 10ml and Actemra 162mg/ 0.9ml which have been registered for circulation in Vietnam; Actemra 400 mg/20 mL drug has not been registered for circulation in Vietnam.

Thus, the product Actemra 400 mg/20 mL has not been licensed to import by the Drug Administration of Vietnam, and has not been granted a circulation registration certificate in Vietnam.

The Drug Administration of Vietnam proposed that the Departments of Health of the provinces, centrally-run cities, and health departments strengthen the inspection and examination of drug business establishments, wholesalers and retailers in the area, ensuring business. drugs with full valid invoices and vouchers; promptly detect and prevent acts of trading in drugs of unknown origin and smuggled drugs.

Quynh Anh

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