KUALA LUMPUR: The Health Ministry has given conditional registration approval for use of the Ronapreve Solution for Injection or Infusion in the treatment and prevention of Covid-19.

       Health director-general Tan Sri Dr Noor Hisham Abdullah (pic) said the matter was approved at the 367th Drug Control Authority meeting held on Monday.

       However, he stressed that Ronapreve is not intended to be used as a substitute for Covid-19 vaccination.

       “Ronapreve is indicated for treatment in adults and adolescents aged 12 years and above, and weighing at least 40kg, who do not require supplemental oxygen and who are at increased risk of progressing to severe Covid-19.

       “On prevention, Ronapreve is indicated for adults and adolescents aged above 12 and weighing at least 40kg, who have been exposed or are at high risk of exposure to SARS-CoV-2, and who either have a medical condition making them unlikely to respond to or be protected by vaccination, or are not vaccinated,” he said in a statement.

       SARS-CoV-2 is the name of the coronavirus that causes Covid-19.

       Dr Noor Hisham said the conditional registration approval required the quality, safety and effectiveness of the product to be monitored and evaluated based on the latest data from time to time, to ensure that the benefit-over-risk ratio of the product remains positive.

       The registration holder of Ronapreve, which contains the active ingredients casirivimab and imdevimab at a strength of 120mg/ml, is Roche (M) Sdn Bhd.

       It is manufactured by F. Hoffman-La Roche Ltd of Switzerland.

       Dr Noor Hisham also said the National Pharmaceutical Regulatory Agency has approved the application for a Clinical Trial Import Licence (CTIL) for MK-4482 200mg capsule (molnupiravir), which is a Covid-19 prevention product.

       Phase Three of the clinical study will be conducted at two research centres in Malaysia involving 20 people aged 18 and above. – Bernama