BREYANZI SUSPENSION

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LISOCABTAGENE MARALEUCEL

Disponibbli minn:

CELGENE INC

Kodiċi ATC:

L01X

INN (Isem Internazzjonali):

OTHER ANTINEOPLASTIC AGENTS

Dożaġġ:

120000000CELLS

Għamla farmaċewtika:

SUSPENSION

Kompożizzjoni:

LISOCABTAGENE MARALEUCEL 120000000CELLS

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Schedule D

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-05-06

Karatteristiċi tal-prodott

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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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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSA