Ronapreve, a Swiss-made medicine for the treatment and prevention of Covid-19, has received conditional approval from the health ministry.
The solution for injection or infusion contains the active ingredients Casirivimab and Imdevimab and is used to treat those facing a high risk of severe Covid-19 infection.
Ronapreve can be used for those who have a medical condition that makes them unlikely to respond to or be protected by vaccination, or are unvaccinated.
Recipients must be above the age of 12 who weigh at least 40kg and do not require respiratory assistance.
In a statement, health director-general Dr Noor Hisham Abdullah said, however, that Ronapreve is not a replacement for vaccination and Covid-19 rules.
“The health ministry wishes to state that the conditional approval is subject to periodic monitoring on quality, safety and efficacy and evaluation of the latest data,” he said. “This is to ensure the benefit over risk for Ronapreve remains positive.”
Noor Hisham also said the National Pharmaceutical Regulatory Agency (NPRA) has granted Merck Sharp & Dohme (Malaysia) Sdn Bhd and Patheon Pharmaceuticals Inc (US) a clinical trial import license for Molnupiravir, a drug to prevent Covid-19.
He said phase three clinical trials for the drug will be carried out over a period of nine months. The trials will involve 20 people above the age of 18.