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:
Cancelled Post Market
Current status date:
2016-04-04
Original market date: See footnote 1
2004-02-23
Product name:
MENINGITEC
Description:
10 PRE-FILLED SYRINGES
DIN:
02248649
Product Monograph/Veterinary Labelling:
Date:
2013-11-13
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NURON BIOTECH B.V.
Strawinskylaan 1143, Toren 11-C
Amsterdam
Noord-Holland
Netherlands
1077 XX
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
2
Schedule(s):
SCHEDULE D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07AH07 MENINGOCOCCUS C, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED
Active ingredient group (AIG) number:See footnote5
0243741002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN | 15 MCG / 0.5 ML |
| MENINGOCOCCAL GROUP C OLIGOSACCHARIDE | 10 MCG / 0.5 ML |