MedPath

DARZALEX

DARZALEX

Approved
DIN Number

02455978

Drug Class

Human

Market Date

Jul 12, 2016

Company
HC

Janssen Inc

Product Information

Detailed information about this Health Canada approved drug product, including dosage form, route of administration, and regulatory classification.

Product Details

Health Canada regulatory and product classification information

Regulatory Identifiers
DIN Number02455978
AIG Number0158231001
Classification & Schedule
C
Drug Class
Human
S
Schedule
Schedule D ,  Prescription
A
ATC Code
L01FC01 DARATUMUMAB
Product Specifications
Dosage FormSolution
Route of AdministrationIntravenous
AHFS Classification10:00.00
Health Canada Classification

ACTIVE INGREDIENTS (1)

DARATUMUMABActive
Strength: 400 MG / 20 ML
Monograph: DARATUMUMAB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.