MINT-OLOPATADINE 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:

0.1%

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:

2014-05-30

Summary of Product characteristics

_Page 1 of 18 _
PRODUCT MONOGRAPH
Pr
MINT-OLOPATADINE
Olopatadine Hydrochloride Ophthalmic Solution
0.1% w/v (as olopatadine hydrochloride)
USP
Anti-allergy Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Date of Revision:
Mississauga, Ontario
November 27, 2020
Canada L5T 2M3
Control Number: 241215
_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
............................................................. 6
STORAGE AND STABILITY
............................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 8
PART II: SCIENTIFIC INFORMATION
.................................................................................9
PHARMACEUTICAL INFORMATION
...........................................................................
9
CLINICAL TRIALS
..........................................................................................................
10
DETAILED PHARMACOLOGY
.............................