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:
Cancelled Pre Market
Current status date:
2022-07-13
Original market date: See footnote 1
Product name:
GEMCITABINE FOR INJECTION, USP
DIN:
02437163
Product Monograph/Veterinary Labelling:
Date:
2022-06-14
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
DR REDDY'S LABORATORIES LTD
Survey Nos 42,45,46,54 Bachupally, Quthbullapur
Hyderabad
Telangana
India
500090
Class:
Human
Dosage form(s):
Powder
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01BC05 GEMCITABINE
Active ingredient group (AIG) number:See footnote5
0133122003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GEMCITABINE (GEMCITABINE HYDROCHLORIDE) | 1 G / VIAL |