Approval · Notice of Compliance 13716 · 2012
PENTACEL: Notice of Compliance 13716
Issued October 12, 2012
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
- 13716
- Date
- October 12, 2012
- Company
- Sanofi Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New master seed lot
- Therapeutic class
- Active Immunizing Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PENTACEL | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID 15 LF per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O) TYPE 1 MAHONEY 40 DU per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 M.E.F.1 8 DU per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT 32 DU per 0.5ML
- TETANUS PROTEIN 30 MCG per 0.5ML
- TETANUS TOXOID 5 LF per 0.5ML
- HAEMOPHILUS INFLUENZAE TYPE B-PRP 10 MCG per 0.5ML
- PERTUSSIS TOXOID 20 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ 20 MCG per 0.5ML
- PERTACTIN 3 MCG per 0.5ML
- FIMBRIAE TYPES 2 AND 3 (FIM) 5 MCG per 0.5ML