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:
Approved
Current status date:
2017-09-19
Product name:
TOBRAMYCIN INHALATION SOLUTION USP
DIN:
02457563
Product Monograph/Veterinary Labelling:
Date:
2018-04-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville
Quebec
Canada
J7C 3V4
Class:
Human
Dosage form(s):
Solution
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
0110230004
| Active ingredient(s) | Strength |
|---|---|
| TOBRAMYCIN (TOBRAMYCIN SULFATE) | 300 MG / 5 ML |