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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:

2018-01-17

Original market date: See footnote 1

2018-01-17

Product name:

BELBUCA

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:

02465221

Product Monograph/Veterinary Labelling:

Date: 2018-02-15 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

PURDUE PHARMA
575 Granite Court
Pickering
Ontario
Canada  L1W 3W8

Class: 

Human

Dosage form(s):

Film, Soluble

Route(s) of administration:

Buccal

Number of active ingredient(s):

1

Schedule(s):

Narcotic (CDSA I)  

American Hospital Formulary Service (AHFS): See footnote 3

28:08.12   OPIATE PARTIAL AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AE01  BUPRENORPHINE

Active ingredient group (AIG) number:See footnote 5

0142241010

List of active ingredient(s)
Active ingredient(s) Strength
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 75 MCG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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