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:
2023-10-04
Original market date: See footnote 1
2023-10-04
Product name:
GANCICLOVIR FOR INJECTION
Description:
SINGLE-USE VIAL
DIN:
02537168
Product Monograph/Veterinary Labelling:
Date:
2023-04-12
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
FORMATIVE PHARMA INC.
200
4145 North Service Road
Burlington
Ontario
Canada
L7L 6A3
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
08:18.32
Anatomical Therapeutic Chemical (ATC): See footnote 4
J05AB06 GANCICLOVIR
Active ingredient group (AIG) number:See footnote5
0128037002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GANCICLOVIR (GANCICLOVIR SODIUM) | 500 MG / VIAL |