Approval · Notice of Compliance 4733 · 1996
SABRIL: Notice of Compliance 4733
Issued November 13, 1996
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
- 4733
- Date
- November 13, 1996
- Company
- Hoechst Marion Roussel Canada Inc.Laval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: as initial monotherapy for the management of infantile spasms (west syndrome)
- Therapeutic class
- Anti-epileptic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SABRIL | Not yet assigned | — |
Medicinal ingredients
- VIGABATRIN 3 G per PCK
- VIGABATRIN 0.5 G per PCK
- VIGABATRIN 500 MG per TAB
- VIGABATRIN 1 G per PCK
- VIGABATRIN 2 G per PCK