Approval · Notice of Compliance 13815 · 2012
CETROTIDE: Notice of Compliance 13815
Issued November 2, 2012
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
- 13815
- Date
- November 2, 2012
- Company
- Emd Serono A Division Of Emd Inc CanadaMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in the drug substance manufacturer, new manufacturing process, new container closure system for the drug product and the diluent
- Therapeutic class
- Gnrh antagonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CETROTIDE | Not yet assigned | — |
Medicinal ingredients
- CETRORELIX ACETATE 0.25 MG per VIAL
- CETRORELIX ACETATE 3 MG per VIAL