Another molnupiravir drug authorised for use in COVID-19 treatment

There are now four Molnupiravir-based drugs produced in Vietnam approved for domestic use. (Photo: suckhoedoisong.vn)

Hanoi (VNA) – , a drug produced and registered
by Stellapharm J.V.Co. Ltd., has been authorised by the Drug
Administration of Vietnam (DAV) for the domestic treatment of COVID-19.

This
is the fourth produced in Vietnam to be authorised for
use in the country.

The
DAV orders manufacturers to adhere to documents registered with the
Ministry of Health; coordinate with treatment facilities to strictly comply with
current regulations on prescription drugs, monitor the safety, effectiveness,
and unwanted effects of drugs on Vietnamese people, as well
as compile reports according to regulations.

At
the same time, the DAV also requested local departments of health notify
medical examination and treatment facilities, medical staff, and drug suppliers
in the area to inform patients of the benefits and risks when using
Molnupiravir, including treatments, as well as alternatives for Molnupiravir in
the treatment of .

In
addition, it requires units to strengthen monitoring, supervision and detection
of cases of adverse drug reactions (if any), to send reports to the National
Center for Drug Information and Adverse Drug Reaction Monitoring (Hanoi) or
Regional Center for Drug Information and Adverse Drug reaction monitoring (Ho Chi
Minh City), according to regulations.

The
DAV orders 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 the leaflets for drugs containing Molnupiravir approved in
reference countries around the world to update the unified instruction sheet
for Molnupiravir drugs.

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

–
Information related to drug ADR reports and information on the safety and efficacy
of drugs circulating in Vietnam.

The
decision of the Drug Administration also states that in the course of drug
circulation, based on monitoring and updating information on the safety and
effectiveness of the three drugs above, the  can
revoke the drug registration under the provisions of Clause 1, Article 58
of the Law on Pharmacy./.