Approval · Notice of Compliance 38429 · 2026
SEPHIENCE: Notice of Compliance 38429
Issued October 7, 2026
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
- 38429
- Date
- October 7, 2026
- Company
- Ptc Therapeutics International LimitedDublin, Ireland
- 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 starting material. Addition of a manufacturing site and/or manufacturer involving production of the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SEPHIENCE | Not yet assigned | — |
Medicinal ingredients
- SEPIAPTERIN 250 MG per SACHET
- SEPIAPTERIN 1,000 MG per SACHET