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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:

1993-12-31

Original market date: See footnote 1

1993-12-31

Product name:

PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION.2MG/ML

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:

02016095

Product Monograph/Veterinary Labelling:

Date: 2019-07-02 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

PHARMASCIENCE INC
100  6111 Royalmount Ave
Montreal
Quebec
Canada  H4P 2T4

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

OTC  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

56:08.00   ANTIDIARRHEA AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

A07DA03  LOPERAMIDE

Active ingredient group (AIG) number:See footnote 5

0111332002

List of active ingredient(s)
Active ingredient(s) Strength
LOPERAMIDE HYDROCHLORIDE 0.2 MG / ML

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