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:
2005-10-07
Original market date: See footnote 1
2004-04-30
Product name:
REMODULIN
DIN:
02246554
Product Monograph/Veterinary Labelling:
Date:
2017-06-13
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
UNITED THERAPEUTICS CORPORATION
55 T.W. Alexander Drive
Research Triangle Park
North Carolina
United States
27709
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous , Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
48:48.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
B01AC21 TREPROSTINIL
Active ingredient group (AIG) number:See footnote5
0148361003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TREPROSTINIL (TREPROSTINIL SODIUM) | 5 MG / ML |