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:
2015-05-22
Original market date: See footnote 1
2012-07-26
Product name:
ORALAIR
Description:
GRASS POLLEN ALLERGEN EXTRACT 300 IR (COMPOSED OF COCKSFOOT, SWEET VERNAL GRASS, RYE GRASS, MEADOW GRASS & TIMOTHY)
DIN:
02381893
Product Monograph/Veterinary Labelling:
Date:
2016-11-18
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
STALLERGENES CANADA INC
UNIT 102
8449 Lawson Road
Milton
Ontario
Canada
L9T 9L1
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Sublingual
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
92:05.00* See footnote6
Anatomical Therapeutic Chemical (ATC): See footnote 4
V01AA02 GRASS POLLEN
Active ingredient group (AIG) number:See footnote5
0153132002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GRASS POLLEN ALLERGEN EXTRACT | 300 UNIT |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Patient Education |