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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:

2014-04-29

Original market date: See footnote 1

2014-04-29

Product name:

AURO-PRAMIPEXOLE

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:

02424088

Product Monograph/Veterinary Labelling:

Date: 2018-07-10 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

AURO PHARMA INC
3700 Steeles Avenue West, Suite 402
Woodbridge
Ontario
Canada  L4L 8K8

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

28:36.20.08   NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N04BC05  PRAMIPEXOLE

Active ingredient group (AIG) number:See footnote 5

0152169002

List of active ingredient(s)
Active ingredient(s) Strength
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG

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