Approval · Notice of Compliance 35975 · 2025
ACCUTANE: Notice of Compliance 35975
Issued September 5, 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
- 35975
- Date
- September 5, 2025
- Company
- Cheplapharm Schweiz GmbhBinningen, Switzerland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- Administrative: Change in manufacturer and product name
Products in this notice
Medicinal ingredients
- ISOTRETINOIN 10 MG per CAP
- ISOTRETINOIN 40 MG per CAP