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HSA Approval

JYNNEOS SUSPENSION FOR INJECTION

Approval Number

SIN17067P

Drug Name

JYNNEOS SUSPENSION FOR INJECTION

Product Name

JYNNEOS SUSPENSION FOR INJECTION

Approval Date

August 23, 2024

Registrant

AENON PHARMACEUTICALS SEA PTE. LTD.

Regulatory Information

Registrant

AENON PHARMACEUTICALS SEA PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SUSPENSION

Route of Administration

SUBCUTANEOUS

Medical Information

ATC Code

J07BX01

Manufacturer Information

Pharmaceutical Manufacturer

AENON PHARMACEUTICALS SEA PTE. LTD.

Manufacturers

Bavarian Nordic A/S

Grand River Aseptic Manufacturing (Butterworth)

Active Ingredients

Ingredient Name

Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN, live, non-replicating)

Strength

0.5 x 10^8 to 3.95 x 10^8 Inf. U /dose

Drug MonographModified vaccinia ankara

Documents

Package Inserts

Jynneos Suspension for Injection PI.pdf

Approved: August 23, 2024

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