DARZALEX SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DARATUMUMAB

Dostopno od:

JANSSEN INC

Koda artikla:

L01FC01

INN (mednarodno ime):

DARATUMUMAB

Odmerek:

400MG

Farmacevtska oblika:

SOLUTION

Sestava:

DARATUMUMAB 400MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

20ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0158231001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-06-29

Lastnosti izdelka

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_~db5_O45c4cbb6cf344ac795947c915bd4e672.docx_
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_EDMS-RIM-760894 v.12.0_
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_Darzalex SC (daratumumab injection) _
_Page 1 of 120_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DARZALEX® SC
daratumumab injection
1800 mg/15 mL (120 mg/mL) Solution for Subcutaneous Injection
Professed Standard
Antineoplastic, monoclonal antibody
ATC code L01FC01
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
July 29, 2020
Date of Revision:
May 29, 2023
Submission Control Number: 265459
All trademarks used under license
© 2023 Janssen Inc.
_ _
_ _
_~db5_O45c4cbb6cf344ac795947c915bd4e672.docx_
_ _
_EDMS-RIM-760894 v.12.0_
_ _
_Darzalex SC (daratumumab injection) _
_Page 2 of 120_
RECENT MAJOR LABEL CHANGES
1 Indications
12/2022
1 Indications, 1.3 Cardiac disease
04/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
12/2022
4 Dosage and Administration, 4.4 Administration
04/2021
7 Warnings and Precautions
12/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
12/2022
7 Warnings and Precautions, 7.1.2 Breast-Feeding
12/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
12/2022
7 Warnings and Precautions, 7.1.7 Cardiac Disease
04/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
5
1 INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
.................................................