Approval · Notice of Compliance 22165 · 2019
ACCUTANE ROCHE: Notice of Compliance 22165
Issued May 15, 2019
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
- 22165
- Date
- May 15, 2019
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To align inner and outer labels to comply with Plain Language Labelling (PLL) Regulations & Good Label and Package Practice Guides for Perscription Drugs (GLPPG)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACCUTANE ROCHE | Not yet assigned | — |
Medicinal ingredients
- ISOTRETINOIN 10 MG per CAP
- ISOTRETINOIN 40 MG per CAP