Jakarta – The Indonesian Food and Drug Supervisory Company (BPOM) has issued emergency-use authorization (EUA) for COVID-19 antiviral drug Molnupiravir.
” After going through an assessment of the scientific trial information together with the specialist team of the National Committee for Drug Evaluation and the clinical association for EUA approval, BPOM and the Ministry of Health continue to keep an eye on the security of using Molnupiravir in Indonesia,” head of BPOM, Cent K Lukito, said in a press release gotten here on Friday.
The authorized Molnupiravir medication remains in the type of 200 mg capsules signed up by PT Amarox Pharma Global and manufactured by Hetero Labs Ltd., India, Lukito notified.
The drug is indicated to treat mild to moderate COVID-19 infection in clients aged 18 years and above who do not need oxygen administration and have actually an increased risk of establishing severe COVID-19 infection, she stated.
” The drug is offered two times a day, as much as four pills of 200 mg each, for 5 days,” she kept in mind.
Earlier, BPOM had issued EUA for numerous COVID-19 drugs, consisting of antiviral drugs Favipiravir and Remdesivir and monoclonal antibody Regdanvimab.
The outcomes of the examination have revealed Molnupiravir is fairly safe and produces tolerable side-effects, Lukito said. The most typically reported side-effects consist of nausea, headache, stomach discomfort, and oropharyngeal pain, she added.
In addition, the outcomes of non-clinical trials and scientific trials have actually shown that Molnupiravir does not trigger liver function conditions, she noted. Nevertheless, Molnupiravir must not be prescribed to pregnant women and women of productive age who are using contraceptives, she added.
Regarding the efficacy element, the outcomes of the Stage Three medical trial have shown that Molnupiravir could minimize the threat of hospitalization by 30 percent in mild to moderate COVID-19 clients and 24.9 percent in mild COVID-19 patients, she informed.
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To support of the availability of COVID-19 drugs in Indonesia, PT Amarox Pharma Global is getting ready for regional production of Molnupiravir pills through transfer innovation at the Amarox Cikarang production center in Bekasi District, West Java, she notified.
” A letter of approval for using non-betalactam pill production facilities was provided on January 3, 2022, and after the requirements for Good Production Practices of Drugs (GMP) can be fulfilled by the industry, the local production is prepared to be prepared in early March2022 This boosts our joint efforts to support the independence of the domestic drug industry,” she said.
In addition, BPOM is also supervising the production and distribution chain of drugs so that the safety, effectiveness, and quality of drugs can be maintained to avoid using illegal drugs, she added.
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