PUTRAJAYA, April 7 — The Ministry of Health (MOH) has agreed to grant additional indication 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 approval was made at the 383rd Drug Control Authority (DCA) meeting which convened yesterday (April 6).
Earlier, the 372nd meeting agreed to grant conditional registration approval for the same product. The conditional approval status remains and the latest approval is for additional indications for the treatment of COVID-19.
Evusheld is used to treat adult and adolescent COVID-19 patients (12 years of age and above) weighing at least 40 kilogrammes who do not require oxygen support and are at high risk for more severe coronavirus infection, he said in a statement today.
It is also used on individuals who may not have an adequate immune response to COVID-19 vaccination or for individuals for whom COVID-19 vaccination is not recommended.
“The use of Evusheld was based on clinical guidelines issued by MOH,” Dr Noor Hisham said.
