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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
Evusheld Solution for Injection 100mg/ml 2022/08/01 AstraZeneca Singapore Pte Ltd  AstraZeneca UK Limited   NA Samsung Biologics Company Limited, Republic of Korea
Moderna Spikevax COVID-19 Vaccine 0.1mg/ml Multidose Vial
2022/08/24 Zuellig Pharma Pte. Ltd.
Moderna Biotech Spain, S.L.   
Rovi Pharma Industrial Services, S.A., San Sebastian de los Reyes, Spain  
Moderna Spikevax COVID-19 Vaccine 0.1mg/ml Pre-filled Syringe
2022/08/24
Zuellig Pharma Pte. Ltd.
Moderna Biotech Spain, S.L.  
Rovi Pharma Industrial Services, S.A., Julian Camarillo, Spain 
Moderna Spikevax Bivalent Original / Omicron COVID-19 Vaccine 0.1 mg/mL Dispersion for Injection
2022/09/14 Moderna Biotech Singapore Pte. Ltd Moderna Biotech Spain S.L.

  • Rovi Pharma Industrial Services, S.A., Spain
  • Recipharm Monts, France 
Comirnaty (Bivalent) Original / Omicron BA.4-5 COVID-19 Vaccine 15/15 mg per Dose Dispersion for Injection
2022/10/11  BioNTech Pharmaceutical Asia Pacific Pte. Ltd.  BioNTech SE
  • Pfizer Manufacturing Belgium NV, Belgium
  • BioNTech Manufacturing Marburg GmbH, Germany
  • Allergopharma GmbH & Co. KG, Germany
  • Sanofi-Aventis Deutschland GmbH, Germany
  • mibe GmbH Arzneimittel, Germany 

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, 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/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/PIL please refer to the Register of Therapeutic Products

COMIRNATY, 
Concentrate for Dispersion for Injection, 3 micrograms/dose

SIN16616P  2022/09/28  BioNTech Pharmaceuticals Asia Pacific Pte Ltd.  For the latest approved PI/PIL please refer to the Register of Therapeutic Products

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