Hanoi (VNA) – Molnupiravir Stella 200mg, a drug produced and registered by Stellapharm JVCo. Ltd., has been authorized by the Drug Administration of Vietnam (DAV) for the nationwide treatment of COVID-19.
It’s the fourth Molnupiravir medicine produced in Vietnam to be licensed for use in the country.
The DAV directs manufacturers to comply with documents registered with the Ministry of Health; coordinate with treatment institutions to strictly comply with existing prescription drug regulations, monitor the safety, efficacy and adverse effects of drugs on Vietnamese people, as well as compile reports in accordance with regulations.
At the same time, the DAV also instructed local health departments to inform medical examination and treatment institutions, medical personnel and drug suppliers in the area to inform patients about the benefits and risks of the use of molnupiravir, including treatments, as well as alternatives to molnupiravir. in the treatment of COVID-19[feminine].
In addition, it requires units to strengthen monitoring, supervision and case detection of adverse drug reactions (if any), send reports to the National Center for Drug Information and Adverse Drug Reaction Monitoring (Hanoi) or at the Regional Center for Drug Information and Adverse Reactions. Monitoring of drug reactions (Ho Chi Minh City), in accordance with regulations.
The DAV directs the National Center for Drug Information and Adverse Drug Reactions Monitoring-Hanoi University of Pharmacy, the Regional Center for Drug Information and Adverse Drug Reactions Monitoring in HCM City-Cho Ray Hospital, and the Center for Clinical Pharmacology-Hanoi Medical University to be responsible for monitoring, updating and reporting the following information to the Department:
– Information in package inserts of drugs containing Molnupiravir approved in reference countries around the world to update the unified instruction sheet for Molnupiravir drugs.
– Information relating to the safety and efficacy of Molnupiravir-containing medicinal products assessed by drug regulatory authorities around the world, the World Health Organization and information on the use and circulation status of drugs containing Molnupiravir worldwide.
– Information related to adverse drug reaction reports and information on the safety and efficacy of drugs circulating in Vietnam.
The Drug Administration’s decision also states that during drug circulation, based on monitoring and updating information on the safety and efficacy of the above three drugs, the Vietnam Drug Administration may revoke the registration of the drug under the provisions of clause 1 of article 58 of the Pharmacy Act./.