国: カナダ
言語: 英語
ソース: Health Canada
ONASEMNOGENE ABEPARVOVEC
NOVARTIS PHARMACEUTICALS CANADA INC
M09AX09
ONASEMNOGENE ABEPARVOVEC
20000000000000VG
SOLUTION
ONASEMNOGENE ABEPARVOVEC 20000000000000VG
INTRAVENOUS
5.5ML AND 8.3ML
Prescription
CELLULAR AND GENE THERAPY
Active ingredient group (AIG) number: 0162641001; AHFS:
APPROVED
2020-12-15
_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 .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE 完全なドキュメントを読む