MedPath
HSA Approval

EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML

SIN17106P

EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML

EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML

October 2, 2024

ABBVIE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantABBVIE PTE. LTD.

Product Classification

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

Formulation Information

INJECTION, SOLUTION

SUBCUTANEOUS

Medical Information

L01FX27

Manufacturer Information

ABBVIE PTE. LTD.

Vetter Pharma-Fertigung GmbH & Co. KG

Active Ingredients

Epcoritamab

48mg/0.8mL

Epcoritamab

Documents

Package Inserts

Epkinly PI.pdf

Approved: October 2, 2024

Download

Patient Information Leaflets

Epkinly PIL.pdf

Approved: October 2, 2024

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML - HSA Approval | MedPath