(Bloomberg) — Malaysia’s Drug Control Authority has granted conditional registration for Ronapreve Solution for Injection or Infusion, according to Health Director-General Noor Hisham Abdullah in a statement.
- The drug’s registration holder is Roche (Malaysia) Sdn and it is produced by F. Hoffman-La Roche Ltd., Switzerland
- It can be used for the treatment and prevention of Covid-19 in adults and adolescents 12 years and older
- The conditional registration requires monitoring and evaluation of the quality, safety and efficacy of the product based on latest data from time to time
- Malaysia’s National Pharmaceutical Regulatory Agency has approved an application for a Clinical Trial Import License from Merck Sharpe & Dohme (Malaysia) Sdn and Patheon Pharmaceuticals Inc for the Covid prevention drug MK-4482 200mg capsule (Molnupiravir)
- The nine-month-long trials will involve three phases and will be carried out in two research institutes in Malaysia, involving 20 people 18 years and older
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