Approval · Notice of Compliance 19621 · 2017
ACTONEL: Notice of Compliance 19621
Issued August 3, 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
- 19621
- Date
- August 3, 2017
- Company
- Allergan Pharma Co.Markham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- Change to the DIN owner Removing the 75mg strength Change in Part III to the 2014 Patient Mediciation Information (PMI) format and changes to the package inserts and product labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACTONEL | 02242518 | Cancelled Post Market |
| ACTONEL | 02239146 | Cancelled Post Market |
| ACTONEL | 02246896 | Marketed |
| ACTONEL | 02316838 | Marketed |
| ACTONEL DR | 02370417 | Marketed |
Medicinal ingredients
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE 5 MG per TAB
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE 30 MG per TAB
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE 35 MG per TAB
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE 150 MG per TAB