Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2014-05-09
Original market date: See footnote 1
2014-05-09
Product name:
PROQUAD
DIN:
02399229
Product Monograph/Veterinary Labelling:
Date:
2024-10-02
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MERCK CANADA INC
16750 Route Transcanadienne
Kirkland
Quebec
Canada
H9H 4M7
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
4
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BD54 MEASLES, COMBINATIONS WITH MUMPS, RUBELLA AND VARICELLA, LIVE ATTENUATED
Active ingredient group (AIG) number:See footnote5
0466265001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MEASLES VIRUS LIVE ATTENUATED (EDMONSTON STRAIN) | 3.00 Log10 TCID50 / 0.5 ML |
| MUMPS VIRUS LIVE ATTENUATED (JERYL LYNN STRAIN) | 4.30 Log10 TCID50 / 0.5 ML |
| RUBELLA VIRUS LIVE ATTENUATED (WISTAR RA27/3 STRAIN) | 3.00 Log10 TCID50 / 0.5 ML |
| VARICELLA VIRUS LIVE ATTENUATED (OKA/MERCK STRAIN) | 3.99 Log10 PFU / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.