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:

2016-09-15

Original market date: See footnote 1

1978-12-31

Product name:

DEPAKENE

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:

00443832

Product Monograph/Veterinary Labelling:

Date: 2023-02-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BGP PHARMA ULC
85 Advance Road
Etobicoke
Ontario
Canada M8Z 2S6

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

28:12.92 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N03AG01 VALPROIC ACID

Active ingredient group (AIG) number:See footnote5

0112996002

List of active ingredient(s)
Active ingredient(s) Strength
VALPROIC ACID (SODIUM VALPROATE) 250 MG / 5 ML

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
Patient Wallet Card
Version 4.0.2
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