KUALA LUMPUR: The Health Ministry has given a conditional registration approval for Remdesivir for the treatment of Covid-19.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the decision was made during the Drug Control Authority's 374th meeting today.
The product registration holder of the Veklury lyophilised powder for injection (Remdesivir 100mg/vial) is Gilead Sciences Malaysia Sdn Bhd and the manufacturer is Patheon Manufacturing Services LLC of the United States.
Dr Noor Hisham explained that Veklury is indicated for the treatment of coronavirus in adults and paediatric patients aged 12 years and above, weighing at least 40kg.
"The medicine will be given to Covid-19 patients who are hospitalised or not hospitalised but have mild to moderate symptoms and are at high risk for progression to severe Covid-19, which may result in hospitalisation or death."
Dr Noor Hisham stressed that Remdesivir is not meant to replace Covid-19 vaccines and public health action, particularly compliance with standard operating procedures.
He said the National Pharmaceutical Regulatory Agency would continuously monitor and evaluate the quality, safety and effectiveness of this antivirus product from time to time.
"This is to ensure that the comparison of benefits over risk for the product remains positive," he added.