Approval · Notice of Compliance 15516 · 2014
REVOLADE: Notice of Compliance 15516
Issued March 27, 2014
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
- 15516
- Date
- March 27, 2014
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new strength - 75 mg tablet. addition of new indication; to increase platelet counts in thrombocytopenic patients with chronic hepatgitis C virus (hcv)
- Therapeutic class
- Thrombopoietin receptor agonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REVOLADE | Not yet assigned | — |
| REVOLADE | 02423049 | Cancelled Pre Market |
Medicinal ingredients
- ELTROMBOPAG OLAMINE 25 MG per TAB
- ELTROMBOPAG OLAMINE 50 MG per TAB
- ELTROMBOPAG OLAMINE 75 MG per TAB