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:
2022-04-11
Original market date: See footnote 1
2022-04-11
Product name:
DIACETYLMORPHINE HYDROCHLORIDE
DIN:
02525003
Product Monograph/Veterinary Labelling:
Date:
2023-05-11
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PHARMASCIENCE INC
100
6111 Royalmount Ave
Montreal
Quebec
Canada
H4P 2T4
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intramuscular , 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
N07BC06 DIAMORPHINE
Active ingredient group (AIG) number:See footnote5
0117249004
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DIAMORPHINE HYDROCHLORIDE | 5000 MG / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Controlled Distribution Program |
| Healthcare Professional Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |