ApprovalTrail

Approval · Notice of Compliance 36254 · 2025

DOPTELET: Notice of Compliance 36254

Issued October 24, 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
36254
Date
October 24, 2025
Company
Swedish Orphan Biovitrum Ab (Publ)Stockholm, --, Sweden
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Change in the drug product manufacturing process

Products in this notice

BrandDINStatus today
DOPTELETNot yet assigned—

Medicinal ingredients