Approval · Notice of Compliance 19261 · 2017
REVOLADE: Notice of Compliance 19261
Issued May 5, 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.
- Notice number
- 19261
- Date
- May 5, 2017
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the product monograph to reflect safety data from a post-marketing study that evaluated the potential risk for increased bone marrow reticulin formation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REVOLADE | Not yet assigned | — |
Medicinal ingredients
- ELTROMBOPAG OLAMINE 25 MG per TAB
- ELTROMBOPAG OLAMINE 50 MG per TAB
- ELTROMBOPAG OLAMINE 75 MG per TAB
- ELTROMBOPAG OLAMINE 12.5 MG per TAB