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 Post Market
Current status date:
2016-01-30
Original market date: See footnote 1
2006-03-14
Product name:
KEPIVANCE
DIN:
02274221
Product Monograph/Veterinary Labelling:
Date:
2014-10-10
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
Tomtebodav 23a
Stockholm
--
Sweden
11276
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
84:16.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
V03AF08 PALIFERMIN
Active ingredient group (AIG) number:See footnote5
0151563001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| PALIFERMIN | 6.25 MG / VIAL |