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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:

2021-04-20

Original market date: See footnote 1

2016-04-05

Product name:

BETEFLAM

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:

02449773

Product Monograph/Veterinary Labelling:

Date: 2021-04-19 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

IBSA INSTITUT BIOCHIMIQUE SA
Via Del Piano P.O. Box 266
Pambio-Noranco
Ticino
Switzerland  6915

Class: 

Human

Dosage form(s):

Patch

Route(s) of administration:

Topical

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

84:06.00   ANTI-INFLAMMATORY AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

D07AC01  BETAMETHASONE

Active ingredient group (AIG) number:See footnote 5

0106302001

List of active ingredient(s)
Active ingredient(s) Strength
BETAMETHASONE VALERATE 0.1 % / W/W

Risk Management Plans See footnote 7

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

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