Approval · Notice of Compliance 15965 · 2014
TRELSTAR: Notice of Compliance 15965
Issued August 15, 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.
- Notice number
- 15965
- Date
- August 15, 2014
- Company
- Paladin Labs Inc
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the finished product specifications; (1) revision of the dissolusion test conditions and acceptance criteria to introduce an accelerated ddissolution test and (2) introduction of test for container closure integrity as an alternative to sterility testing by direct inoculation
- Therapeutic class
- Luteinizing hormone-releasing hormone (lhrh) analogue
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRELSTAR | Not yet assigned | — |
Medicinal ingredients
- TRIPTORELIN PAMOATE 3.75 MG per VIAL
- TRIPTORELIN PAMOATE 11.25 MG per VIAL