MINT-OLOPATADINE 0.2% SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE)

Available from:

MINT PHARMACEUTICALS INC

ATC code:

S01GX09

INN (International Name):

OLOPATADINE

Dosage:

0.2%

Pharmaceutical form:

SOLUTION

Composition:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.2%

Administration route:

OPHTHALMIC

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTIALLERGIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0132394002; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-03-04

Summary of Product characteristics

_ MINT-OLOPATADINE 0.2% (_
Olopatadine Hydrochloride Ophthalmic Solution
_) _
Page 1 of 23
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-OLOPATADINE 0.2%
Olopatadine Hydrochloride Ophthalmic Solution
0.2% w/v olopatadine (as olopatadine hydrochloride), topical
USP
Anti-allergy Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario L5T 2M3
Canada
Date of Initial Authorization:
NOV 23, 2020
Date of Revision:
NOV 14, 2023
Submission Control Number: 278540
_ _
_MINT-OLOPATADINE 0.2% (_
Olopatadine Hydrochloride Ophthalmic Solution
_) _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
None at the time of authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.5
Missed Dose
.............................................................