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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:

2019-10-30

Original market date: See footnote 1

1964-12-31

Product name:

ISOPTO ATROPINE

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:

00035017

Product Monograph/Veterinary Labelling:

Date: 2018-02-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ALCON CANADA INC
2665 Meadowpine Blvd
Mississauga
Ontario
Canada  L5N 8C7

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Ophthalmic

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

52:24.00   MYDRIATICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

S01FA01  ATROPINE

Active ingredient group (AIG) number:See footnote 5

0104748001

List of active ingredient(s)
Active ingredient(s) Strength
ATROPINE SULFATE 1 % / W/V

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