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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 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
  • Allergopharma GmbH & Co. KG, 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
  • Samsung Biologics Company Limited, Republic of Korea
 
 
Sotrovimab Injection 500mg/8ml  2021/06/30 GlaxoSmithKline Pte Ltd  GlaxoSmithKline (Ireland) Ltd      GlaxoSmithKline Manufacturing S.p.A., Italy 
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
Paxlovid Tablets (Nirmatrelvir 150mg and Ritonavir 100mg) 2022/01/31 Pfizer Private Limited Pfizer Inc.
  • Pfizer Manufacturing Deutschland GmbH, Germany
  • AbbVie Deutschland GmbH & Co KG, Germany
  • Pfizer Italia S.r.L, Italy
  • Anderson Brecon Inc., USA

Nuvaxovid Covid-19 Vaccine

 2022/02/03

PharmEng Technology Pte Ltd

 

Novavax, Inc.  Serum Institute of India Private Limited(Manjari), India 
Lagevrio Capsule 200 mg (Molnupiravir 200 mg) 2022/04/19  MSD Pharma (Singapore) Pte. Ltd. Merck Sharp & Dohme Corp.
  • Patheon Pharmaceuticals Inc., USA
  • MSD International GmbH (Puerto Rico Branch) LLC, USA
  • Patheon Inc., Canada
  • Merck Sharp & Dohme Corp. Wilson Plant, USA
  • Sharp Corporation, USA
  • Merck Sharp & Dohme BV, Netherlands

The following PSAR-authorised emergency therapeutic products have been granted product registration:

Product name Product registration number Date of product registration Name of product registrant Information for healthcare professionals Information for recipients and caregivers
COMIRNATY, Dispersion for Injection, 30 micrograms/dose
 SIN16396P 2021/12/10 BioNTech Pharmaceuticals Asia Pacific Pte Ltd. 
For the latest approved PI, please refer to the Register of Therapeutic Products For the latest approved PIL, please refer to the Register of Therapeutic Products 
COMIRNATY, Concentrate for Dispersion for Injection, 10 micrograms/dose SIN16397P
2021/12/10
BioNTech Pharmaceuticals Asia Pacific Pte Ltd. 
For the latest approved PI, please refer to the Register of Therapeutic Products For the latest approved PIL, please refer to the Register of Therapeutic Products 

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