KUALA LUMPUR: The Health Ministry has given conditional registration approval for Ronapreve to be used in treatment and prevention of Covid-19, says Tan Sri Dr Noor Hisham Abdullah.
The Health director-general said this was decided during the 37th Drug Control Authority meeting on Monday (Dec 13).
However, he stressed that this was not a replacement for vaccination or to ignore existing standard operating procedures.
The Swiss-made Ronapreve solution for injection or infusion contains active ingredients comprising Casirivimab and Imdevimab.
“Ronapreve is indicated for the treatment of Covid-19 in adults and adolescents aged 12 years and older and weighing at least 40kg who do not require supplemental oxygen for Covid-19 and who are at increased risk of progressing to severe Covid-19,” Dr Noor Hisham said in a statement on Tuesday (Dec 14).
Meanwhile, for prevention, Ronapreve is indicated for the prevention of Covid-19 in adults and adolescents aged 12 years and older and weighing at least 40kg who have been exposed or at high risk of exposure to SARS-CoV-2.
He further added that it is also indicated for those who have a medical condition making them unlikely to respond or be protected by vaccination, or are unvaccinated against Covid-19.
Dr Noor Hisham also said that the National Pharmaceutical Regulatory Agency (NPRA) had also approved the Clinical Trial Import License (CTIL) for Molnupiravir, another Covid-19 prevention product.
“This Phase Three clinical study will be conducted in two research centres in Malaysia with a target number of subjects of 20 people aged 18 years and above.
“The study is expected to take nine months and is part of a study conducted globally involving various countries,” he said.