LUCENTIS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANIBIZUMAB

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

S01LA04

INN (International Name):

RANIBIZUMAB

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

RANIBIZUMAB 10MG

Administration route:

INTRAVITREAL

Units in package:

0.23ML

Prescription type:

Prescription

Therapeutic area:

EENT DRUGS, MISCELLANEOUS

Product summary:

Active ingredient group (AIG) number: 0152224001; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-04-04

Summary of Product characteristics

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_Page 1 of 112_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUCENTIS
®
ranibizumab injection
Single Use Vials, Single Use Pre-filled Syringes
10 mg/mL solution for intravitreal injection
Anti-Vascular Endothelial Growth Factor-A (VEGF-A inhibitor)
ATC Code: S01LA04
Lucentis indicated in preterm infants for:

the treatment of retinopathy of prematurity (ROP) with zone I [stage 1
with plus disease
(1+), stage 2 with plus disease (2+), or stage 3 with or without plus
disease (3 or 3+)], or
zone II [stage 3 with plus disease (3+)] or aggressive posterior ROP
(AP-ROP) disease.
has been issued market authorization with conditions, pending the
results of trials to verify its
clinical benefit. Patients should be advised of the nature of the
authorization.
For further information for LUCENTIS please refer to Health Canada’s
Notice of Compliance
with conditions - drug products web site:
https://www.canada.ca/en/health-
canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html
Lucentis, indicated in adults for:

the treatment of neovascular (wet) age related macular degeneration
(AMD).

the treatment of visual impairment due to diabetic macular edema
(DME).

the treatment of visual impairment due to macular edema secondary to
retinal vein occlusion
(RVO).

the treatment of visual impairment due to choroidal neovascularisation
(CNV) secondary to
pathologic myopia (PM).

the treatment of visual impairment due to choroidal neovascularisation
(CNV) secondary to
ocular conditions other than AMD or PM, including but not limited to
angioid streaks, post-
inflammatory retinochoroidopathy, central serous chorioretinopathy or
idiopathic
chorioretinopathy.
has been issued market authorization without conditions.
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Initial Approval:
June 26, 2007
Date of Revision:
September 28, 2022
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_LUCENTIS_
_®_
_ (ranibizumab injection) _
_Page 2 of 112_
SUBMISSION CONTROL NO: 263995
LUC