Approval · Notice of Compliance 30737 · 2023
SELEXID: Notice of Compliance 30737
Issued May 10, 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
- 30737
- Date
- May 10, 2023
- Company
- Knight Therapeutics Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- DIN re-activation Product Monograph reformatted to the master template To update the product monograph with new safety information concerning severe cutaneous adverse reactions (scar) angioedema and anaphylactic shock and with respect to potential interaction with laboratory test for acylcarnitines in newborn screening
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SELEXID | Not yet assigned | — |
Medicinal ingredients
- PIVMECILLINAM HCL 200 MG per TAB
- PIVMECILLINAM HCL 400 MG per TAB