Product information
From Health Canada
No match found
No other product was found with the same active ingredient group.
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:
2006-10-16
Original market date: See footnote 1
2006-10-16
Product name:
ROTATEQ
Description:
ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT. PREFILLED 2ML UNIT DOSE TUBE
DIN:
02284413
Product Monograph/Veterinary Labelling:
Date:
2018-01-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MERCK CANADA INC
16750 Route Transcanadienne
Kirkland
Quebec
Canada
H9H 4M7
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Oral
Number of active ingredient(s):
5
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BH02 ROTA VIRUS, PENTAVALENT, LIVE, REASSORTED
Active ingredient group (AIG) number:See footnote5
0551661001
| Active ingredient(s) | Strength |
|---|---|
| HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G1 | 2210000 UNIT / DOSE |
| HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G2 | 2840000 UNIT / DOSE |
| HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G3 | 2220000 UNIT / DOSE |
| HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G4 | 2040000 UNIT / DOSE |
| HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE P1(8) | 2290000 UNIT / DOSE |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.