TEVA-TRAVOPROST Z OPHTHALMIC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRAVOPROST

Available from:

TEVA CANADA LIMITED

ATC code:

S01EE04

INN (International Name):

TRAVOPROST

Dosage:

0.004%

Pharmaceutical form:

SOLUTION

Composition:

TRAVOPROST 0.004%

Administration route:

OPHTHALMIC

Units in package:

2.5ML/5ML

Prescription type:

Prescription

Therapeutic area:

PROSTAGLANDIN ANALOGS

Product summary:

Active ingredient group (AIG) number: 0145801001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-06-10

Summary of Product characteristics

_ _
_Teva-Travoprost Z Ophthalmic Solution, 0.004% w/v _
_Page 1 of 24 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TRAVOPROST Z OPHTHALMIC SOLUTION
Travoprost Ophthalmic Solution
0.004% w/v
Teva Standard
Elevated Intraocular Pressure Therapy
Prostaglandin F
2α
analogue
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Date of Revision:
September 30, 2019
Submission Control No: 231715
_ _
_Teva-Travoprost Z Ophthalmic Solution, 0.004% w/v _
_Page 2 of 24_
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
................................................................................11
PHARMACEUTICAL INFORMATION
..........................................................................11
CLI