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HSA Approval

Spikevax dispersion for injection 50mcg/0.5ml in single-dose vial

SIN17129P

Spikevax dispersion for injection 50mcg/0.5ml in single-dose vial

Spikevax dispersion for injection 50mcg/0.5ml in single-dose vial

October 30, 2024

MODERNA BIOTECH SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantMODERNA BIOTECH SINGAPORE PTE. LTD.

Product Classification

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

Formulation Information

INJECTION, SOLUTION

INTRAMUSCULAR

Medical Information

J07BN01

Manufacturer Information

MODERNA BIOTECH SINGAPORE PTE. LTD.

Rovi Pharma Industrial Services, S.A. San Sebastián de los Reyes (Rovi SSRR)

ModernaTX, Inc. (manufacturer of SM-102 LNP & mRNA-1273 LNPs-B)

Active Ingredients

Andusomeran

0.05mg / 0.5ml

Documents

Package Inserts

Spikevax SDV PI.pdf

Approved: October 30, 2024

Download

Patient Information Leaflets

Spikevax SDV PIL.pdf

Approved: October 30, 2024

Download

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Spikevax dispersion for injection 50mcg/0.5ml in single-dose vial - HSA Approval | MedPath