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BOTOX DIN 01981501

Status: Marketed
Holder: ABBVIE CORPORATION
Molecule: ONABOTULINUMTOXINA
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Health Canada record

Active ingredient(s)ONABOTULINUMTOXINA 100 UNIT
Dosage formPowder For Solution
RouteIntramuscular; Intradetrusorial; Intradermal
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCM03AX01 BOTULINUM TOXIN
Original market date31-Dec-1992
Current status date13-Nov-2023
SourceHealth Canada DPD

Establishment licence of the holder

AbbVie Corporation — licence 101988, currently licensed, last inspection rating C (2023-07-18).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing ONABOTULINUMTOXINA

DINProductCompanyFormStrengthStatus
02531577BOTOXABBVIE CORPORATIONPowder For SolutionONABOTULINUMTOXINA 50 UNITMarketed
02531585BOTOXABBVIE CORPORATIONPowder For SolutionONABOTULINUMTOXINA 200 UNITMarketed
02243721BOTOX COSMETICABBVIE CORPORATIONPowder For SolutionONABOTULINUMTOXINA 100 UNITMarketed
02531445BOTOX COSMETICABBVIE CORPORATIONPowder For SolutionONABOTULINUMTOXINA 50 UNITApproved

Notices of Compliance

NOCDateSubmissionReason
289422022-09-09New Drug Submission (NDS)Administrative - Change in Product Ownership
42441996-09-19Supplement to a New Drug Submission (SNDS)ALTERNATE MANUFACTURING SITE
48931995-03-29Supplement to a New Drug Submission (SNDS)REVISED PRODUCT MONOGRAPH, NEW INDICATION: TO REDUCE THE SUBJECTIVE SYMPTOMS AND OBJECTIVE SIGNS OF CERVICAL DYSTONIA (SPASMODIC TORTICOLLIS) IN ADULTS
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