BREYANZI SUSPENSION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

LISOCABTAGENE MARALEUCEL

Inapatikana kutoka:

CELGENE INC

ATC kanuni:

L01X

INN (Jina la Kimataifa):

OTHER ANTINEOPLASTIC AGENTS

Kipimo:

120000000CELLS

Dawa fomu:

SUSPENSION

Tungo:

LISOCABTAGENE MARALEUCEL 120000000CELLS

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

100

Dawa ya aina:

Schedule D

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2022-05-06

Tabia za bidhaa

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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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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSA