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:

2017-11-24

Original market date: See footnote 1

2014-12-10

Product name:

PMS-BUPRENORPHINE-NALOXONE

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DIN:

02424851

Product Monograph/Veterinary Labelling:

Date: 2023-09-25 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

PHARMASCIENCE INC
100 6111 Royalmount Ave
Montreal
Quebec
Canada H4P 2T4

Class:

Human

Dosage form(s):

Tablet

Route(s) of administration:

Sublingual

Number of active ingredient(s):

2

Schedule(s):

Narcotic (CDSA I)

 

American Hospital Formulary Service (AHFS): See footnote 3

28:10.00  ,  28:08.12 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N07BC51 BUPRENORPHINE, COMBINATIONS

Active ingredient group (AIG) number:See footnote5

0252216001

List of active ingredient(s)
Active ingredient(s) Strength
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2 MG
NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5 MG

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
Version 4.0.2
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