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:

1981-12-31

Original market date: See footnote 1

1981-12-31

Product name:

PROLOPA CAP 50-12.5

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:

00522597

Product Monograph/Veterinary Labelling:

Date: 2019-08-02 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):

Capsule

Route(s) of administration:

Oral

Number of active ingredient(s):

2

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

28:36.16 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N04BA02 LEVODOPA AND DECARBOXYLASE INHIBITOR

Active ingredient group (AIG) number:See footnote5

0211634003

List of active ingredient(s)
Active ingredient(s) Strength
BENSERAZIDE (BENSERAZIDE HYDROCHLORIDE) 12.5 MG
LEVODOPA 50 MG
Version 4.0.2
Date modified: