DARZALEX SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DARATUMUMAB

Dostopno od:

JANSSEN INC

Koda artikla:

L01FC01

INN (mednarodno ime):

DARATUMUMAB

Odmerek:

100MG

Farmacevtska oblika:

SOLUTION

Sestava:

DARATUMUMAB 100MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

5ML

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

_~db5_Oac54e46c9e98425794855d4eadebbcc0.docx_
_ _
_ EDMS-RIM-746978 v12.0 _
_Darzalex (daratumumab for injection) _
_Page 1 of 95_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DARZALEX®
daratumumab for injection
20 mg/mL Concentrate for Solution for Infusion
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:
June 29, 2016
Date of Revision:
May 29, 2023
Submission Control Number: 265459
All trademarks used under license.
© 2023 Janssen Inc.
_~db5_Oac54e46c9e98425794855d4eadebbcc0.docx_
_ _
_ EDMS-RIM-746978 v12.0 _
_Darzalex (daratumumab for injection) _
_Page 2 of 95_
RECENT MAJOR LABEL CHANGES
1 Indications
12/2022
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
12/2022
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
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
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SER