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Emergency therapeutic products granted PSAR authorisation

HSA has granted interim authorisation for the emergency therapeutic products (TP) listed below.

Emergency TP Date of interim authorisation Name of interim authorisation holder Name of product owner Information for healthcare professionals Information for vaccine recipients and caregivers Manufacturing site, Country
Pfizer-BioNTech COVID-19 Vaccine 2020/12/14  BioNTech Pharmaceuticals Asia Pacific Pte Ltd.   BioNTech SE    
  • Polymun Scientific Immunbiologische Forschung GmbH, Austria
  • Pfizer Manufacturing Belgium NV, Belgium
  • Pharmacia & Upjohn Company LLC, United States
  • Mibe GmbH Arzneimittel, Germany
  • Exelead, Inc., United States
  • BioNTech Manufacturing Marburg GmbH, Germany
 
 
Moderna COVID-19 Vaccine/ Spikevax COVID-19 Vaccine 2021/02/03    Zuellig Pharma Pte. Ltd. Moderna Biotech Spain, S.L.      
  • ModernaTX, Inc., United States
  • Catalent Indiana, LLC, United States 
  • Rovi Pharma Industrial Services, S.A., Spain
  • Recipharm Monts, France
 
 
Sotrovimab Injection 500mg/8ml  2021/06/30 GlaxoSmithKline Pte Ltd  GlaxoSmithKline (Ireland) Ltd      GlaxoSmithKline Manufacturing S.p.A., Italy 
Pfizer-BioNTech Comirnaty COVID-19 Vaccine  2021/09/14  BioNTech Pharmaceuticals Asia Pacific Pte. Ltd.   BioNTech SE    
  • Polymun Scientific Immunbiologische Forschung GmbH, Austria
  • Pfizer Manufacturing Belgium NV, Belgium
  • Mibe GmbH Arzneimittel, Germany
  • Allergopharma GmbH & Co. KG, Germany
  • BioNTech Manufacturing Marburg GmbH, Germany
 
Casirivimab and Imdevimab 120 mg/mL Concentrate for Solution for Infusion 2021/09/21   Roche Singapore Pte Ltd  F. Hoffmann-La Roche Ltd      Genentech, Inc., United States 
CoronaVac COVID-19 Vaccine 2021/10/23 Sinovac Biotech (Singapore) Pte. Ltd. Sinovac Life Sciences Co., Ltd.   NA Sinovac Life Sciences Co., Ltd., China
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