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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:

2013-09-16

Original market date: See footnote 1

2009-05-25

Product name:

SOLIRIS

Description:

SINGLE USE, 300 MG/30ML

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:

02322285

Product Monograph/Veterinary Labelling:

Date: 2021-03-25 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:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

92:32.00   COMPLEMENT INHIBITORS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AA25  ECULIZUMAB

Active ingredient group (AIG) number:See footnote 5

0152512001

List of active ingredient(s)
Active ingredient(s) Strength
ECULIZUMAB 10 MG / ML

Application information

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