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This Article is From Dec 14, 2021

Malaysia Conditionally Approves Ronapreve for Covid Treatment

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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