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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:

2020-02-07

Original market date: See footnote 1

2020-02-07

Product name:

VASCEPA

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:

02495244

Product Monograph/Veterinary Labelling:

Date: 2019-12-30 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

HLS THERAPEUTICS INC
10 Carlson Court, Suite 701
Etobicoke
Ontario
Canada  M9W 6L2

Class: 

Human

Dosage form(s):

Capsule

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

24:06.92   MISCELLANEOUS ANTILIPEMIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

C10AX  OTHER LIPID MODIFYING AGENTS

Active ingredient group (AIG) number:See footnote 5

0162013001

List of active ingredient(s)
Active ingredient(s) Strength
ICOSAPENT ETHYL 1 G

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