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:
2021-04-29
Original market date: See footnote 1
2021-04-29
Product name:
MORPHINE SULFATE INJECTION
DIN:
02500728
Product Monograph/Veterinary Labelling:
Date:
2020-06-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JAMP PHARMA CORPORATION
1310 Rue Nobel
Boucherville
Quebec
Canada
J4B 5H3
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intramuscular , Subcutaneous , Intravenous
Number of active ingredient(s):
1
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AA01 MORPHINE
Active ingredient group (AIG) number:See footnote5
0104545001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MORPHINE SULFATE | 10 MG / ML |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.