BREYANZI SUSPENSION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LISOCABTAGENE MARALEUCEL

Boleh didapati daripada:

CELGENE INC

Kod ATC:

L01X

INN (Nama Antarabangsa):

OTHER ANTINEOPLASTIC AGENTS

Dos:

120000000CELLS

Borang farmaseutikal:

SUSPENSION

Komposisi:

LISOCABTAGENE MARALEUCEL 120000000CELLS

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

100

Jenis preskripsi:

Schedule D

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2022-05-06

Ciri produk

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_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.
_ _
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_BREYANZI (lisocabtagene maraleucel) _
_Page 2 of 39_
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TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
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2
CONTRAINDICATIONS
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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DOSA