Approval · Notice of Compliance 36125 · 2025
SEPHIENCE: Notice of Compliance 36125
Issued October 7, 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
- 36125
- Date
- October 7, 2025
- Company
- Ptc Therapeutics International LimitedDublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Priority-NAS
Products in this notice
Medicinal ingredients
- SEPIAPTERIN 250 MG per SACHET
- SEPIAPTERIN 1,000 MG per SACHET