BREYANZI SUSPENSION

国: カナダ

言語: 英語

ソース: Health Canada

即購入

製品の特徴 製品の特徴 (SPC)
06-05-2022

有効成分:

LISOCABTAGENE MARALEUCEL

から入手可能:

CELGENE INC

ATCコード:

L01X

INN(国際名):

OTHER ANTINEOPLASTIC AGENTS

投薬量:

120000000CELLS

医薬品形態:

SUSPENSION

構図:

LISOCABTAGENE MARALEUCEL 120000000CELLS

投与経路:

INTRAVENOUS

パッケージ内のユニット:

100

処方タイプ:

Schedule D

製品概要:

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

認証ステータス:

APPROVED

承認日:

2022-05-06

製品の特徴

                                _ _
_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_
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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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1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
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2
CONTRAINDICATIONS
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SERIOUS WARNINGS AND PRECAUTIONS BOX
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DOSA
                                
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製品の特徴 製品の特徴 フランス語 06-05-2022

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