ZOLGENSMA SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ONASEMNOGENE ABEPARVOVEC

Dostopno od:

NOVARTIS PHARMACEUTICALS CANADA INC

Koda artikla:

M09AX09

INN (mednarodno ime):

ONASEMNOGENE ABEPARVOVEC

Odmerek:

20000000000000VG

Farmacevtska oblika:

SOLUTION

Sestava:

ONASEMNOGENE ABEPARVOVEC 20000000000000VG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

5.5ML AND 8.3ML

Tip zastaranja:

Prescription

Terapevtsko območje:

CELLULAR AND GENE THERAPY

Povzetek izdelek:

Active ingredient group (AIG) number: 0162641001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-12-15

Lastnosti izdelka

_ZOLGENSMA_
_®_
_ (onasemnogene abeparvovec) _
_Page 1 of 36 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZOLGENSMA®
onasemnogene abeparvovec
Solution for intravenous infusion, 2 × 10
13
vector genomes/mL
Other drugs for disorders of the musculo-skeletal system
ATC code: M09AX09
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., Suite 100
Montreal, Quebec
H2Y 0C1
Date of Initial Authorization:
December 15, 2020
Date of Revision:
March 19, 2024
Submission Control Number: 274469
ZOLGENSMA is a registered trademark
_ _
_ZOLGENSMA_
_®_
_ (onasemnogene abeparvovec) _
_Page 2 of 36 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
01/2024
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
03/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
03/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
03/2023
7 WARNINGS AND PRECAUTIONS, Immune
03/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
11/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE