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:

Marketed

Current status date:

2009-04-15

Original market date: See footnote 1

2009-04-15

Product name:

NPLATE

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:

02322854

Product Monograph/Veterinary Labelling:

Date: 2021-08-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

AMGEN CANADA INC
300 6775 Financial Drive
Mississauga
Ontario
Canada L5N 0A4

Class:

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

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

B02BX04 ROMIPLOSTIM

Active ingredient group (AIG) number:See footnote5

0152535003

List of active ingredient(s)
Active ingredient(s) Strength
ROMIPLOSTIM 250 MCG / VIAL

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
Pharmacovigilance/Monitoring Activity
Registry
Prescription Event Monitoring
Version 4.0.2
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