Approval · Notice of Compliance 19776 · 2017
KEYTRUDA: Notice of Compliance 19776
Issued September 8, 2017
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
- 19776
- Date
- September 8, 2017
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: refractory or relapsed classical hodgkin lymphoma 9chl as monotherapy iin adults who have failed autologous stem cell transplant (asct) and brentouximab vedotin (bv) or who are not asct candidates and have failed bv
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL
- PEMBROLIZUMAB 25 MG per ML