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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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

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  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

80:12.00   VACCINES

Anatomical Therapeutic Chemical (ATC): See footnote 4

J07BH02  ROTAVIRUS,PENTAVALENT,LIVE,REASSORTED

Active ingredient group (AIG) number:See footnote 5

0551661001

List of active ingredient(s)
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

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