BREYANZI SUSPENSION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

LISOCABTAGENE MARALEUCEL

Prieinama:

CELGENE INC

ATC kodas:

L01X

INN (Tarptautinis Pavadinimas):

OTHER ANTINEOPLASTIC AGENTS

Dozė:

120000000CELLS

Vaisto forma:

SUSPENSION

Sudėtis:

LISOCABTAGENE MARALEUCEL 120000000CELLS

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

100

Recepto tipas:

Schedule D

Produkto santrauka:

Active ingredient group (AIG) number: 0163641001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2022-05-06

Prekės savybės

_ _
_BREYANZI (lisocabtagene maraleucel) _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BREYANZI
TM
lisocabtagene maraleucel
Cell suspension in patient-specific single-dose vials, 60 x 10
6
to 120 x 10
6
chimeric antigen receptor
(CAR)-positive viable T cells (consisting of CD4 and CD8 components at
a ratio range from 0.8 to 1.2),
for intravenous infusion
Professed Standard
Other antineoplastic agent (Anatomical Therapeutic Chemical index
code: L01X)
Celgene Inc., a Bristol Myers Squibb company
2344 Alfred-Nobel
Suite 300
Saint-Laurent, Quebec
H4S 0A4
Date of Initial Authorization:
May 6, 2022
Submission Control Number: 247562
©2021 Bristol-Myers Squibb Company
BREYANZI is a trademark of Juno Therapeutics, Inc., used under license
by Celgene Inc.
_ _
_ _
_BREYANZI (lisocabtagene maraleucel) _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
[Section number and heading], [Subsection number and heading]
[MM/YYYY]
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
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
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSA