DARZALEX SC SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DARATUMUMAB

Mevcut itibaren:

JANSSEN INC

ATC kodu:

L01FC01

INN (International Adı):

DARATUMUMAB

Doz:

1800MG

Farmasötik formu:

SOLUTION

Kompozisyon:

DARATUMUMAB 1800MG

Uygulama yolu:

SUBCUTANEOUS

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0158231002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2020-07-29

Ürün özellikleri

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_PM Darzalex SC.docx_
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_EDMS-RIM-413055 v8.0_
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_Darzalex SC (daratumumab injection) _
_Page 1 of 118_
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:
November 22, 2022
Submission Control Number: 259880
All trademarks used under license
© 2022 Janssen Inc.
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_ _
_PM Darzalex SC.docx_
_ _
_EDMS-RIM-413055 v8.0_
_ _
_Darzalex SC (daratumumab injection) _
_Page 2 of 118_
RECENT MAJOR LABEL CHANGES
1 Indications
TBD/2022
1 Indications, 1.3 Cardiac disease
04/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
TBD/2022
4 Dosage and Administration, 4.4 Administration
04/2021
7 Warnings and Precautions
TBD/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
TBD/2022
7 Warnings and Precautions, 7.1.2 Breast-Feeding
TBD/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
TBD/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....................................................................................................