ApprovalTrail

Approval · Notice of Compliance 35664 · 2025

PRO-ELETRIPTAN: Notice of Compliance 35664

Issued June 11, 2025

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
35664
Date
June 11, 2025
Company
Pro Doc LimiteeLaval, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Admin
Reason
Administrative: Change in product name. Administrative: Update to labelling (to match Licensor)
Canadian reference product
RELPAX (Pfizer Canada Ulc)

Products in this notice

BrandDINStatus today
PRO-ELETRIPTAN02489961Marketed
PRO-ELETRIPTAN02489988Marketed

Medicinal ingredients