Approval · Notice of Compliance 21873 · 2019
M-ESLON: Notice of Compliance 21873
Issued February 20, 2019
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
- 21873
- Date
- February 20, 2019
- Company
- Ethypharm IncMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To update labels in accordance with PLL, removing patient information leaflet from packaging and removing reference to 200 mg blister pack from PM.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| M-ESLON | Not yet assigned | — |
Medicinal ingredients
- MORPHINE SULFATE 10 MG per CAP
- MORPHINE SULFATE 15 MG per CAP
- MORPHINE SULFATE 30 MG per CAP
- MORPHINE SULFATE 60 MG per CAP
- MORPHINE SULFATE 100 MG per CAP
- MORPHINE SULFATE 200 MG per CAP