Approval · Notice of Compliance 31499 · 2023
TEPMETKO: Notice of Compliance 31499
Issued August 25, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 31499
- Date
- August 25, 2023
- 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
- Fulfillment of some post-approval commitments for the Notice of Compliance with conditions.
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TEPMETKO | Not yet assigned | — |
Medicinal ingredients
- TEPOTINIB HYDROCHLORIDE 225 MG per TAB