Approval · Notice of Compliance 12806 · 2011
PYLERA: Notice of Compliance 12806
Issued November 29, 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
- 12806
- Date
- November 29, 2011
- Company
- Aptalis Pharma Canada UlcMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer Name Change
- Therapeutic class
- Helicobacter Pylori Eradication Therapy in Conjuction with Omeprazole
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PYLERA | 02246962 | Marketed |
Medicinal ingredients
- BISMUTH OXIDE 40 MG per CAP
- METRONIDAZOLE 125 MG per CAP
- TETRACYCLINE HCL 125 MG per CAP