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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:

2014-05-14

Original market date: See footnote 1

2014-05-14

Product name:

FENTORA

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:

02408031

Product Monograph/Veterinary Labelling:

Date: 2020-05-28 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

TEVA CANADA LIMITED
30 Novopharm Court
Toronto
Ontario
Canada  M1B 2K9

Class: 

Human

Dosage form(s):

Tablet (Effervescent)

Route(s) of administration:

Buccal,  Sublingual

Number of active ingredient(s):

1

Schedule(s):

Narcotic (CDSA I)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08   OPIATE AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AB03  FENTANYL

Active ingredient group (AIG) number:See footnote 5

0123302019

List of active ingredient(s)
Active ingredient(s) Strength
FENTANYL (FENTANYL CITRATE) 600 MCG

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Healthcare Professional Education
Patient Education
Pharmacovigilance/Monitoring Activity
Drug Utilisation Study (DUS) study

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