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:
2023-12-18
Original market date: See footnote 1
2023-12-18
Product name:
LUPIN-TIOTROPIUM
DIN:
02537850
Product Monograph/Veterinary Labelling:
Date:
2023-05-10
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LUPIN PHARMA CANADA LIMITED
550-1111 Rue St-Charles Ouest
Longueuil
Quebec
Canada
J4K 5G4
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Inhalation
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
12:08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
R03BB04 TIOTROPIUM BROMIDE
Active ingredient group (AIG) number:See footnote5
0148683001
| Active ingredient(s) | Strength |
|---|---|
| TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) | 18 MCG |