Approval · Notice of Compliance 15761 · 2014
AFINITOR: Notice of Compliance 15761
Issued May 30, 2014
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 15761
- Date
- May 30, 2014
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revision of the sega indication and its dosing information and authorization of paediatric tablets for oral suspension
- Therapeutic class
- Antineoplastic Agent (mTOR kinase inhibitor)
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AFINITOR | Not yet assigned | — |
| AFINITOR DISPERZ | 02425645 | Marketed |
| AFINITOR DISPERZ | 02425653 | Marketed |
| AFINITOR DISPERZ | 02425661 | Marketed |
Medicinal ingredients
- EVEROLIMUS 2.5 MG per TAB
- EVEROLIMUS 5 MG per TAB
- EVEROLIMUS 10 MG per TAB
- EVEROLIMUS 2 MG per TAB
- EVEROLIMUS 3 MG per TAB