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:

Cancelled Pre Market

Current status date:

2023-06-01

Original market date: See footnote 1

Product name:

MIRCERA

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:

02308126

Product Monograph/Veterinary Labelling:

Date: 2008-03-31 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

HOFFMANN-LA ROCHE LIMITED
7070 Mississauga Road
Mississauga
Ontario
Canada L5N 5M8

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous ,  Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription ,  Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

20:16.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B03XA03 METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Active ingredient group (AIG) number:See footnote5

0152455012

List of active ingredient(s)
Active ingredient(s) Strength
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 200 MCG / 0.3 ML
Version 4.0.2
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