Approval · Notice of Compliance 35068 · 2025
PENTACEL: Notice of Compliance 35068
Issued March 24, 2025
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
- 35068
- Date
- March 24, 2025
- Company
- Sanofi Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the manufacturing process of the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PENTACEL | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID ADSORBED 15 LF per 0.5ML
- POLYRIBOSE RIBITOL PHOSPHATE POLYSACCHARIDE (PRP) 10 MCG per 0.5ML
- TETANUS PROTEIN 30 MCG per 0.5ML
- TETANUS TOXOID 5 LF 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
- POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) 29 DU per 0.5ML
- POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) 7 DU per 0.5ML
- POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) 26 DU per 0.5ML
- POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) 40 DU per 0.5ML
- POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) 8 DU per 0.5ML
- POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) 32 DU per 0.5ML