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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:

2016-02-17

Original market date: See footnote 1

2016-02-17

Product name:

STRENSIQ

Description:

80MG/0.8ML SINGLE USE VIAL

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:

02444658

Product Monograph/Veterinary Labelling:

Date: 2020-09-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ALEXION PHARMA GMBH
Giesshubelstrasse 30
Zurich
Zurich
Switzerland  8045

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Schedule D,  Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

44:00.00   ENZYMES

Anatomical Therapeutic Chemical (ATC): See footnote 4

A16AB13  ASFOTASE ALFA

Active ingredient group (AIG) number:See footnote 5

0157271002

List of active ingredient(s)
Active ingredient(s) Strength
ASFOTASE ALFA 100 MG / ML

Application information

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