Regulatory Decision Summary for Hydromorphone Hydrochloride Injection USP
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal Ingredient(s):
Hydromorphone hydrochloride
Control Number:
237401
Therapeutic Area:
Analgesics
Type of Submission:
Supplement to a New Drug Submission
Decision issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) was submitted to request the addition of a new strength at 1 milligram per millilitre (mg/mL).
Why was the decision issued?
Hydromorphone Hydrochloride Injection USP is a parenteral formulation of hydromorphone, a potent opioid. Used as directed, it has a relatively well understood profile of benefits, harms, and uncertainties (BHU). The identified harms and uncertainties are managed with a combination of the safety information contained in the Product Monograph and the post-market Risk Management Plan. The new dosage strength of hydromorphone 1 milligram (mg)/milliliter (mL) can be used for titration, tapering and dose adjustments of therapeutic doses. Therefore, the newly added dosage strength of 1 mg/mL adds further therapeutic versatility to the existing dosage strength of 2 mg/mL. The revisions of the Product Monograph reflect this understanding. Used as instructed, the BHU for the new 1 mg/mL strength is expected to be the same as the existing 2 mg/mL strength. Together, the two dosage strengths provide more choices for clinical uses. Used as instructed, the BHU profile of Hydromorphone Hydrochloride Injection USP remains favourable.
For further details about Hydromorphone hydrochloride injection USP, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2021-04-09
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
02514435
Prescription status:
Available by prescription only
Date Filed:
2020-03-20
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE INJECTION USP | 02514435 | SANDOZ CANADA INCORPORATED | HYDROMORPHONE HYDROCHLORIDE 1 MG / ML |
| HYDROMORPHONE HYDROCHLORIDE INJECTION USP | 02145901 | SANDOZ CANADA INCORPORATED | HYDROMORPHONE HYDROCHLORIDE 2 MG / ML |