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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:

2005-09-03

Original market date: See footnote 1

2001-12-10

Product name:

HYDROMORPHONE HP FORTE INJECTION

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:

02244797

Product Monograph/Veterinary Labelling:

Date: 2019-04-30 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SANDOZ CANADA INCORPORATED
110 Rue De Lauzon
Boucherville
Quebec
Canada  J4B 1E6

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous,  Intramuscular,  Intravenous

Number of active ingredient(s):

1

Schedule(s):

Narcotic (CDSA I)  

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08   OPIATE AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AA03  HYDROMORPHONE

Active ingredient group (AIG) number:See footnote 5

0108698016

List of active ingredient(s)
Active ingredient(s) Strength
HYDROMORPHONE HYDROCHLORIDE 1000 MG / 10 ML

Risk Management Plans See footnote 7

A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.

Additional Risk Minimization Measures
Healthcare Professional Education

Application information

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