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HSA Approval

TECVAYLI SOLUTION FOR INJECTION 10MG/ML

Approval Number

SIN16948P

Drug Name

TECVAYLI SOLUTION FOR INJECTION 10MG/ML

Product Name

TECVAYLI SOLUTION FOR INJECTION 10MG/ML

Approval Date

February 16, 2024

Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION

Route of Administration

SUBCUTANEOUS

Medical Information

ATC Code

Pending

ATC Item Name

xpending

Manufacturer Information

Pharmaceutical Manufacturer

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

Manufacturers

Patheon Manufacturing Services LLC (Bulk production/Primary Packager)

Active Ingredients

Ingredient Name

Teclistamab

Strength

10mg/mL

Drug MonographTeclistamab

Documents

Package Inserts

TECVAYLI Solution for Injection PI.pdf

Approved: February 16, 2024

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TECVAYLI SOLUTION FOR INJECTION 10MG/ML - HSA Approval | MedPath