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HSA Approval

TECVAYLI SOLUTION FOR INJECTION 90MG/ML

SIN16949P

TECVAYLI SOLUTION FOR INJECTION 90MG/ML

TECVAYLI SOLUTION FOR INJECTION 90MG/ML

February 16, 2024

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Product Classification

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

Formulation Information

INJECTION, SOLUTION

SUBCUTANEOUS

Medical Information

Pending

xpending

Manufacturer Information

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

Patheon Manufacturing Services LLC (Bulk production/Primary Packager)

Active Ingredients

Teclistamab

90mg/mL

Teclistamab

Documents

Package Inserts

TECVAYLI Solution for Injection PI.pdf

Approved: February 16, 2024

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TECVAYLI SOLUTION FOR INJECTION 90MG/ML - HSA Approval | MedPath