KUALA LUMPUR – The Health Ministry has agreed to grant conditional registration approval for the product Evusheld 100mg/ml Solution For Injection (Tixagevimab 100mg/ml and Cilgavimab 100 mg/ml) manufactured by Astrazeneca AB of Sweden.
Health Director-General Tan Sri Dr Noor Hisham Abdullah said the product is used to prevent Covid-19 infection following pre-exposure prophylaxis of the virus to adults and adolescents aged 12 and above and weighing at least 40kg.
“In addition, it is also used on an individual who may not have an adequate immune response to Covid-19 vaccination or individuals for 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 meeting which convened today.
He said the use of Evusheld was based on clinical guidelines issued by the ministry and the product was not meant to be used as a substitute for Covid-19 vaccines, while compliance with standard operating procedures 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 Agency to ensure that a product’s benefit-over-risk remains positive. – Bernama, May 12, 2022
