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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:

2019-01-07

Original market date: See footnote 1

2019-01-07

Product name:

TEGSEDI

Description:

SINGLE DOSE PREFILLED SYRINGE

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:

02481383

Product Monograph/Veterinary Labelling:

Date: 2020-06-20 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

AKCEA THERAPEUTICS, INC.
22 Boston Wharf Road, 9th Floor
Boston
Massachusetts
United States  02210

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

92:18.00   ANTISENSE OLIGONUCLEOTIDES

Anatomical Therapeutic Chemical (ATC): See footnote 4

N07XX15  INOTERSEN

Active ingredient group (AIG) number:See footnote 5

0160712001

List of active ingredient(s)
Active ingredient(s) Strength
INOTERSEN (INOTERSEN SODIUM) 284 MG / 1.5 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
Pharmacovigilance/Monitoring Activity
Registry

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