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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:

2014-05-05

Original market date: See footnote 1

2014-05-05

Product name:

ARANESP

Description:

HSA-FREE. 200 MCG/0.4 ML SINGLE-USE PREFILLED SYRINGES (SINGLEJECT)

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:

02391805

Product Monograph/Veterinary Labelling:

Date: 2018-05-24 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

AMGEN CANADA INC
6775 Financial Drive, Suite 100
Mississauga
Ontario
Canada  L5N 0A4

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous,  Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

20:16.00   HEMATOPOIETIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

B03XA02  DARBEPOETIN ALFA

Active ingredient group (AIG) number:See footnote 5

0148081008

List of active ingredient(s)
Active ingredient(s) Strength
DARBEPOETIN ALFA 500 MCG / ML

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