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:
2020-05-11
Original market date: See footnote 1
2020-05-11
Product name:
NIVESTYM
Description:
SINGLE-USE PREFILLED SYRINGE
DIN:
02485575
Product Monograph/Veterinary Labelling:
Date:
2023-10-27
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PFIZER CANADA ULC
17300 Trans-Canada Highway
Kirkland
Quebec
Canada
H9J 2M5
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous , Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
Biosimilar Biologic Drug:
Yes
American Hospital Formulary Service (AHFS): See footnote 3
20:16.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L03AA02 FILGRASTIM
Active ingredient group (AIG) number:See footnote5
0123525003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| FILGRASTIM | 300 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.