Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
ONABOTULINUMTOXINA
ABBVIE CORPORATION
M03AX01
BOTULINUM TOXIN
50UNIT
POWDER FOR SOLUTION
ONABOTULINUMTOXINA 50UNIT
INTRAMUSCULAR
100
Schedule D
Active ingredient group (AIG) number: 0151557003; AHFS:
APPROVED
2022-10-03
_Botox Cosmetic (onabotulinumtoxinA)_ _Page 1 of 27_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BOTOX COSMETIC ® onabotulinumtoxinA _Clostridium botulinum_ type A neurotoxin complex (900kD) Sterile vacuum-dried concentrate powder for solution for injection 50 and 100 Allergan units per vial, intramuscular Pharmaceutical Standard: Ph. Eur. Neuromuscular Paralytic Agent (ATC Code: M03AX01) AbbVie Corporation 8401 Trans-Canada Highway St-Laurent, QC H4S 1Z1 Date of Initial Approval: APR 04, 2001 Date of Revision: NOV 04, 2022 Submission Control No: 263461 _ _ _Botox Cosmetic (onabotulinumtoxinA) _ _Page 2 of 27 _ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Consideration 06/2020 7 WARNINGS AND PRECAUTIONS 06/2020 8 ADVERSE REACTIONS, 8.5 Post Marketing Adverse Reactions 06/2020 9 DRUG INTERACTIONS, 9.4 Drug-Drug Interaction 08/2022 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 ..............................................................5 4 DOSAGE AND ADMINISTRATION.......................................................... Aqra d-dokument sħiħ