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:
2020-03-11
Original market date: See footnote 1
2011-05-12
Product name:
TOBI PODHALER
Description:
TOBRAMYCIN INHALATION POWDER. FOR ORAL INHALATION ONLY.
DIN:
02365154
Product Monograph/Veterinary Labelling:
Date:
2023-10-12
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BGP PHARMA ULC
85 Advance Road
Etobicoke
Ontario
Canada
M8Z 2S6
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
08:12.02
Anatomical Therapeutic Chemical (ATC): See footnote 4
J01GB01 TOBRAMYCIN
Active ingredient group (AIG) number:See footnote5
0110230007
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TOBRAMYCIN | 28 MG |