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HSA Approval

EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML

Approval Number

SIN17105P

Drug Name

EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML

Product Name

EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML

Approval Date

October 2, 2024

Registrant

ABBVIE PTE. LTD.

Regulatory Information

Registrant

ABBVIE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION, CONCENTRATE

Route of Administration

SUBCUTANEOUS

Medical Information

ATC Code

L01FX27

Manufacturer Information

Pharmaceutical Manufacturer

ABBVIE PTE. LTD.

Manufacturers

Vetter Pharma-Fertigung GmbH & Co. KG

Active Ingredients

Ingredient Name

Epcoritamab

Strength

4.0mg/0.8mL

Drug MonographEpcoritamab

Documents

Package Inserts

Epkinly PI.pdf

Approved: October 2, 2024

Patient Information Leaflets

Epkinly PIL.pdf

Approved: October 2, 2024

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