Approval · Notice of Compliance 9461 · 2008
MIRCERA (VIALS): Notice of Compliance 9461
Issued March 31, 2008
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
- 9461
- Date
- March 31, 2008
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Erythropoiesis stimulating agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MIRCERA (VIALS) | 02307995 | Cancelled Pre Market |
| MIRCERA (VIALS) | 02308002 | Cancelled Pre Market |
| MIRCERA (VIALS) | 02308010 | Cancelled Pre Market |
| MIRCERA (VIALS) | 02308029 | Cancelled Pre Market |
| MIRCERA (VIALS) | 02308037 | Cancelled Pre Market |
| MIRCERA (VIALS) | 02308045 | Cancelled Pre Market |
| MIRCERA (VIALS) | 02308053 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308061 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308088 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308096 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308118 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308126 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308134 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308142 | Cancelled Pre Market |
| MIRCERA (PRE-FILLED SYRINGE) | 02308150 | Cancelled Pre Market |
Medicinal ingredients
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 50 MCG per ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 100 MCG per ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 200 MCG per ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 300 MCG per ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 400 MCG per ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 600 MCG per ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 1,000 MCG per ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 50 MCG per 0.3ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 75 MCG per 0.3ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 100 MCG per 0.3ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 150 MCG per 0.3ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 200 MCG per 0.3ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 250 MCG per 0.3ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 400 MCG per 0.6ML
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 600 MCG per 0.6ML