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:

2022-06-16

Original market date: See footnote 1

2022-06-16

Product name:

DIACETYLMORPHINE HYDROCHLORIDE

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02524996

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

0117249003

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
DIAMORPHINE HYDROCHLORIDE 200 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
Version 4.0.3

"Page details"

Date modified: