HÀ NỘI — Molnupiravir Stella 200mg, a drug from Stellapharm J.V.Co. Ltd., has been authorised by the Drug Administration of Việt Nam (DAV) for the domestic treatment of COVID-19.
This is the fourth Molnupiravir-based drug produced in Việt Nam 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 COVID-19.
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 (Hà Nội) or Regional Center for Drug Information and Adverse Drug reaction monitoring (HCMC), according to regulations.
The DAV orders the National Center for Drug Information and Adverse Drug Reactions Monitoring-Hà Nội University of Pharmacy, the Regional Center for Drug Information and Adverse Drug Reactions Monitoring in HCM City-Chợ Rẫy Hospital, and the Center for Clinical Pharmacology-Hà Nội 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 Việt Nam.
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 Drug Administration of Việt Nam can revoke the drug registration under the provisions of Clause 1, Article 58 of the Law on Pharmacy. — VNS
- Read the bottom line: Eye doctors, Independent Health clash over drug costs
- Rego: Psychedelic drug research is beneficial for mental health
- Drug overdose deaths skyrocket among middle-aged women
- Do You Use Drugs? You Can Help The Global Drug Survey Start An Honest Dialogue.
- Racial bias: Federal judge asks if race played role in men's drug charges
- ADC Therapeutics Presents Updated Data from Clinical Trials of Novel Antibody Drug Conjugates
- CBD oil, THC and what you can legally use in Indiana
- XBiotech’s Results from Phase 2 Atopic Dermatitis Study Suggest New Drug to Treat Skin Disease
- Lilly asserts bragging rights over Humira for hot-selling drug Taltz
- Immuron Appoints Gary S. Jacob, Ph.D., Experienced US Based Biotechnology Executive, as CEO
- Cancer Metabolism Based Therapeutics Market – Size, Shape, Trends and Analysis
- Tough choices over a pricey but effective drug for hepatitis C
- Cellworks Study Predicted Non-Response to Azacitidine in MDS Patients with 100% Accuracy using AI-Driven Biosimulation
- Former Boone County judge helps establish drug courts in Vietnam
- Born on drugs: Babies from addicted moms are increasing at an alarming rate in California
- I Took Psychedelic Drugs On A Self-Help Retreat And This Is What I Learned
- Drug overdose at California home leaves 1 dead and a dozen hospitalized
- FDA: Another blood pressure drug under voluntary recall
- Nicox Announces U.S. FDA Acceptance of Investigational New Drug Application for NCX 4251 Phase 2 Trial in Blepharitis
- After Issue 1’s defeat, how best to respond to Ohio’s epidemic of drug deaths: Editorial Board Roundtable
One more molnupiravir-based drug authorised for use in treating COVID-19 have 641 words, post on vietnamnews.vn at May 25, 2022. This is cached page on Talk Vietnam. If you want remove this page, please contact us.