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KUALA LUMPUR, May 12 (Bernama) -- The Ministry of Health (MOH) has agreed to grant conditional registration approval for the product Evusheld 100 milligrammes per millimetre (mg/ml) Solution For Injection (Tixagevimab 100 mg/ml and Cilgavimab 100 mg/ml) manufactured by Astrazeneca AB of Sweden.
Health director-general Tan Sri Dr. Noor Hisham Abdullah said the product was used to prevent COVID-19 infection following pre-exposure prophylaxis of COVID-19 to adults and adolescents aged 12 and above weighing at least 40 kgs.
"In addition, it is also used on an individual who may not have an adequate immune response to COVID-19 vaccination or for individuals whom COVID-19 vaccination is not recommended," he said in a statement here tonight.
According to Dr Noor Hisham, the approval was made at the 372nd Drug Control Authority (DCA) meeting which convened today.
He said the use of Evusheld was based on clinical guidelines issued by MOH, and the product was not meant to be used as a substitute for COVID-19 vaccination, while compliance with standard operating procedures (SOPs) was still required.
He said the conditional registration approval required information on the quality, safety and effectiveness of the product to be monitored and evaluated continuously by the National Pharmaceutical Regulatory Division (NPRA) to ensure that a product’s benefit-over-risk remains positive.