COMBIGAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BRIMONIDINE TARTRATE; TIMOLOL (TIMOLOL MALEATE)

Available from:

ABBVIE CORPORATION

ATC code:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosage:

0.2%; 0.5%

Pharmaceutical form:

SOLUTION

Composition:

BRIMONIDINE TARTRATE 0.2%; TIMOLOL (TIMOLOL MALEATE) 0.5%

Administration route:

OPHTHALMIC

Units in package:

2.5/5/10ML

Prescription type:

Prescription

Therapeutic area:

ALPHA-ADRENERGIC AGONISTS

Product summary:

Active ingredient group (AIG) number: 0249643001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-10-06

Summary of Product characteristics

_COMBIGAN (brimonidine tartrate and timolol) _
_Page 1 of 31 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
COMBIGAN®
brimonidine tartrate / timolol ophthalmic solution
Solution, brimonidine tartrate 0.2% w/v and timolol 0.5% w/v (as
timolol maleate), for ophthalmic use
Relatively Selective α2-adrenoceptor Agonist and β-adrenergic
Blocking Agent
(ATC Code: S01ED51)
Submission Control Number: 267372
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Date of Initial Authorization:
DEC
09, 2003
Date of Revision:
OCT
3,
2022
_COMBIGAN (brimonidine tartrate and timolol) _
_Page 2 of 31 _
_ _
RECENT MAJOR LABEL CHANGES
None at the time of the most recent 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
........................................................ 5
4.3
Administrati