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HSA Approval

NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 mcg/dose (RECOMBINANT, ADJUVANTED) IN SDV

SIN17148P

NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 mcg/dose (RECOMBINANT, ADJUVANTED) IN SDV

NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 mcg/dose (RECOMBINANT, ADJUVANTED) IN SDV

December 16, 2024

PE PHARMA PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPE PHARMA PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SUSPENSION

INTRAMUSCULAR

Medical Information

J07BN04

Manufacturer Information

PE PHARMA PTE. LTD.

Siegfried Hameln GmbH

Active Ingredients

SARS-CoV-2 recombinant spike protein (Omicron JN.1)

5 mcg/dose

Documents

Package Inserts

Nuvaxovid Approved PI.pdf

Approved: December 23, 2024

Patient Information Leaflets

Nuvaxovid Approved PIL.pdf

Approved: December 16, 2024

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NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 mcg/dose (RECOMBINANT, ADJUVANTED) IN SDV - HSA Approval | MedPath