OLOPATADINE OPHTHALMIC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE)

Available from:

BEXIMCO PHARMACEUTICALS CANADA LIMITED

ATC code:

S01GX09

INN (International Name):

OLOPATADINE

Dosage:

0.1%

Pharmaceutical form:

SOLUTION

Composition:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.1%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTIALLERGIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0132394001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-07-04

Summary of Product characteristics

_Beximco Pharmaceuticals Canada Limited _
_Olopatadine Ophthalmic Solution _
_Page 1 of 18_
PRODUCT MONOGRAPH
Pr
OLOPATADINE OPHTHALMIC SOLUTION
Olopatadine Hydrochloride Ophthalmic Solution
0.1% w/v olopatadine (as olopatadine hydrochloride)
USP
Anti-allergy Agent
Beximco Pharmaceuticals Canada Limited
80 Dunstall Crescent
Toronto, ON M1E 3M4
Canada
Date of Revision:
June 29, 2021
Submission
Control No: 248152
_ _
_Beximco Pharmaceuticals Canada Limited _
_Olopatadine Ophthalmic Solution _
_Page 2 of 18_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
............................................................................................
3
WARNINGS AND PRECAUTIONS
............................................................................
3
ADVERSE
REACTIONS.............................................................................................
5
DRUG INTERACTIONS
.............................................................................................
6
DOSAGE AND ADMINISTRATION
..........................................................................
6
OVERDOSAGE
..........................................................................................................
6
ACTION AND CLINICAL
PHARMACOLOGY..........................................................
7
STORAGE AND STABILITY
.....................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 8
PART II: SCIENTIFIC INFORMATION
............................................................................
9
PHARMACEUTICAL INFORMATION
......................................................................
9
CLINICAL TRIALS
......................................