Approval · Notice of Compliance 11982 · 2011
PYLERA: Notice of Compliance 11982
Issued January 4, 2011
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
- 11982
- Date
- January 4, 2011
- Company
- Axcan Pharma Inc.Mont St-Hilaire, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Admin
- Reason
- Product name change
- Therapeutic class
- Helicobacter pylori eradication therapy in conjunction with omeprazole
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PYLERA | 02246962 | Marketed |
Medicinal ingredients
- BISKALCITRATE POTASSIUM 40 MG per CAP
- METRONIDAZOLE 125 MG per CAP
- TETRACYCLINE HCL 125 MG per CAP