ApprovalTrail

Drug · DIN 01981501

BOTOX

Yes: authorized and sold in Canada

Authorized, and the company reports that it sells it in Canada.

Status Marketed since November 13, 2023; first marketed December 31, 1992.
Drug Identification Number (DIN)
01981501
Company (DIN owner)
AbbVie CorporationSaint-Laurent, Quebec, Canada
Schedule
Prescription; Schedule d
Dosage form
Powder For Solution
Route
Intramuscular; Intradetrusorial; Intradermal
Therapeutic class (ATC)
Botulinum toxin M03AX01
Class
Human
Record last updated
May 14, 2026

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
ONABOTULINUMTOXINA100 UNITVIAL

Notices of Compliance

Health Canada approvals that name this DIN.

  • September 9, 2022: NOC 28942New Drug Submission (NDS) · Administrative - Change in Product Ownership
  • September 19, 1996: NOC 4244Supplement to a New Drug Submission (SNDS) · Alternate manufacturing site
  • March 29, 1995: NOC 4893Supplement 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

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “botox”. A notice may cover another product or only some lots: read it to see what it covers.

Other DINs named BOTOX