Approval · Notice of Compliance 31439 · 2023
ELIGARD: Notice of Compliance 31439
Issued August 18, 2023
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
- 31439
- Date
- August 18, 2023
- Company
- Tolmar International Ltd.Dublin, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- 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 7.5 MG per SYR
- LEUPROLIDE ACETATE 22.5 MG per SYR
- LEUPROLIDE ACETATE 30 MG per SYR
- LEUPROLIDE ACETATE 45 MG per SYR