Product information
From Health Canada
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No other product was found from this company.
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:
2018-08-07
Original market date: See footnote 1
Product name:
OFIRMEV
Description:
FOR I.V. INFUSION ONLY. 100ML SINGLE-USE VIALS
DIN:
02408066
Product Monograph/Veterinary Labelling:
Date:
2018-01-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MALLINCKRODT HOSPITAL PRODUCTS INC.
440 Route 22 East
Bridgewater
New Jersey
United States
08807
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:08.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02BE01 ACETAMINOPHEN (PARACETAMOL)
Active ingredient group (AIG) number:See footnote5
0102009015
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ACETAMINOPHEN | 10 MG / ML |