Hanoi (VNA) - Molnupiravir Stella 200mg, a drug produced and registeredby Stellapharm J.V.Co. Ltd., has been authorised by the DrugAdministration of Vietnam (DAV) for the domestic treatment of COVID-19.

Thisis the fourth Molnupiravir-based drug produced in Vietnam to be authorised foruse in the country.

TheDAV orders manufacturers to adhere to documents registered with theMinistry of Health; coordinate with treatment facilities to strictly comply withcurrent regulations on prescription drugs, monitor the safety, effectiveness,and unwanted effects of drugs on Vietnamese people, as wellas compile reports according to regulations.

Atthe same time, the DAV also requested local departments of health notifymedical examination and treatment facilities, medical staff, and drug suppliersin the area to inform patients of the benefits and risks when usingMolnupiravir, including treatments, as well as alternatives for Molnupiravir inthe treatment of COVID-19.

Inaddition, it requires units to strengthen monitoring, supervision and detectionof cases of adverse drug reactions (if any), to send reports to the NationalCenter for Drug Information and Adverse Drug Reaction Monitoring (Hanoi) orRegional Center for Drug Information and Adverse Drug reaction monitoring (Ho ChiMinh City), according to regulations.

TheDAV orders the National Center for Drug Information and Adverse Drug ReactionsMonitoring-Hanoi University of Pharmacy, the Regional Center for Drug Informationand Adverse Drug Reactions Monitoring in HCM City-Cho Ray Hospital, and the Centerfor Clinical Pharmacology-Hanoi Medical University to be responsible formonitoring, updating and reporting the following information to the Department:

-Information in the leaflets for drugs containing Molnupiravir approved inreference countries around the world to update the unified instruction sheetfor Molnupiravir drugs.

-Information related to the safety and effectiveness of drugs containingMolnupiravir evaluated by pharmaceutical regulatory authorities in the world,World Health Organisation and information on the use and circulation status ofdrugs containing Molnupiravir worldwide.

-Information related to drug ADR reports and information on the safety and efficacyof drugs circulating in Vietnam.

Thedecision of the Drug Administration also states that in the course of drugcirculation, based on monitoring and updating information on the safety andeffectiveness of the three drugs above, the Drug Administration of Vietnam canrevoke the drug registration under the provisions of Clause 1, Article 58of the Law on Pharmacy./.