Approval · Notice of Compliance 32612 · 2024
ELIGARD: Notice of Compliance 32612
Issued January 26, 2024
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
- 32612
- Date
- January 26, 2024
- Company
- Tolmar International Ltd.Dublin, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in the primary container closure system(s). Addition of a manufacturing site of the drug product.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ELIGARD | Not yet assigned | — |
Medicinal ingredients
- LEUPROLIDE ACETATE 10.6 MG per 7.5MG
- LEUPROLIDE ACETATE 29.2 MG per 22.5MG
- LEUPROLIDE ACETATE 37.2 MG per 30MG
- LEUPROLIDE ACETATE 59.2 MG per 45MG