LUMIGAN RC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BIMATOPROST

Available from:

ABBVIE CORPORATION

ATC code:

S01EE03

INN (International Name):

BIMATOPROST

Dosage:

0.01%

Pharmaceutical form:

SOLUTION

Composition:

BIMATOPROST 0.01%

Administration route:

OPHTHALMIC

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

PROSTAGLANDIN ANALOGS

Product summary:

Active ingredient group (AIG) number: 0147303002; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-09-01

Summary of Product characteristics

_Page 1 of 30_
_Lumigan RC (bimatoprost)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUMIGAN RC®
bimatoprost ophthalmic solution
Solution, 0.01% w/v, for ophthalmic use
Elevated Intraocular Pressure Therapy
Prostamide Analogue (ATC Code: S01EE03)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Submission Control Number: 266431
Date of Initial Authorization:
SEP 24, 2009
Date of Revision:
SEP 9, 2022
_ _
_Lumigan RC (bimatoprost) _
_Page 2 of 30 _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.4
Administration
.........................................................................................................
4
4.5
Missed Dose
.............................................................................................................
4
5
OVERDOSAGE
............................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................ 5
7
WARNINGS A