Approval · Notice of Compliance 7725 · 2006
TEMODAL: Notice of Compliance 7725
Issued January 31, 2006
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
- 7725
- Date
- January 31, 2006
- Company
- Schering Canada Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment
- Therapeutic class
- Antineoplastic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TEMODAL | Not yet assigned | — |
Medicinal ingredients
- TEMOZOLOMIDE 5 MG per CAP
- TEMOZOLOMIDE 20 MG per CAP
- TEMOZOLOMIDE 100 MG per CAP
- TEMOZOLOMIDE 250 MG per CAP