Approval · Notice of Compliance 25946 · 2021
TEPMETKO: Notice of Compliance 25946
Issued May 27, 2021
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
- 25946
- Date
- May 27, 2021
- Company
- Emd Serono A Division Of Emd Inc CanadaMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TEPMETKO | 02516322 | Marketed |
Medicinal ingredients
- TEPOTINIB HYDROCHLORIDE 225 MG per TAB