Approval · Notice of Compliance 976 · 2000
PENTACEL: Notice of Compliance 976
Issued March 17, 2000
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
- 976
- Date
- March 17, 2000
- Company
- Aventis Pasteur LimitedSwiftwater, Pennsylvania, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Therapeutic class
- Active immune agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PENTACEL | 02231343 | Cancelled Post Market |
Medicinal ingredients
- DIPHTHERIA TOXOID 15 LF per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O) TYPE 1 MAHONEY 40 UNIT per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 M.E.F.1 8 UNIT per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT 32 UNIT per 0.5ML
- TETANUS PROTEIN 20 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 5 MCG per 0.5ML