The Ministry of Health revokes the marketing authorization for 13 types of drugs.

The Drug Administration of Vietnam ( Ministry of Health ) has just issued a decision to revoke the marketing authorization certificates in Vietnam for 13 types of drugs, based on the voluntary request of the drug registration holders.

Illustrative image. (Source: Internet)

Accordingly, the marketing authorization for 13 drugs in Vietnam has been revoked, including:

Tetraspan 6% solution for infusion, intravenous infusion formulation, registration number: VN-18497-14, registered by B. Braun Medical Industries Sdn. Bhd. (Address: Bayan Lepas Free Industrial Zone, 11900 Bayan Lepas, Pulau Pinang, Malaysia). Spiolto Respimat, inhalation solution formulation, registration number VN3-361-21, registered by Boehringer Ingelheim International GmbH (Address: Binger Strasse 173, 55216 Ingelheim am Rhein, Germany). Tamiflu, hard capsule formulation, registration number VN-18299-14, registered by F. Hoffmann-La Roche Ltd. (Address: 124 Grenzacherstrasse, CH-4070 Basel, Switzerland).

MS Contin 10mg, extended-release tablet formulation, registration number VN-21318-18; MS Contin 30mg, extended-release tablet formulation, registration number VN-21319-18; Norspan 10mcg/h, transdermal patch formulation, registration number VN3-266-20; Norspan 20mcg/h, transdermal patch formulation, registration number VN3-267-20; Norspan 5mcg/h, transdermal patch formulation, registration number VN3-268-20, are all registered under Mundipharma Pharmaceuticals Pte. Ltd (Address: 12 Marina View, #22-01 Asia Square Tower 2, Singapore 018961, Singapore).

Vinorelbin “Ebewe”, formulation as a concentrated solution for infusion, registration number VN-20829-17; Calciumfolinat “Ebewe”, formulation as an infusion solution, registration number VN-23089-22; Calciumfolinat “Ebewe”, formulation as an infusion solution, registration number VN-23090-22; Gliclazide Sandoz 30mg, formulation as modified-release tablets, registration number VN-23041-22; Amoxicillin 250mg, formulation as dispersible tablets, registration number VN-22180-19, are all registered under Novartis (Singapore) Pte Ltd (Address: 10 Collyer Quay, #10-01, Ocean Financial Centre Singapore (049315), Singapore).

According to a decision by the Drug Administration of Vietnam, foreign drugs imported into Vietnam before June 21st are permitted to be circulated until their expiration date. Drug registration and manufacturing facilities are responsible for monitoring and ensuring the quality, safety, and effectiveness of the drugs throughout their circulation.

This decision takes effect from the date of signing (June 21, 2023).

PhD

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