LUCENTIS SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

RANIBIZUMAB

Доступна з:

NOVARTIS PHARMACEUTICALS CANADA INC

Код атс:

S01LA04

ІПН (Міжнародна Ім'я):

RANIBIZUMAB

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

RANIBIZUMAB 10MG

Адміністрація маршрут:

INTRAVITREAL

Одиниць в упаковці:

0.165ML

Тип рецепту:

Prescription

Терапевтична области:

EENT DRUGS, MISCELLANEOUS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2014-05-28

Характеристики продукта

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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
_ _
_LUCENTIS_
_®_
_ (ranibizumab injection) _
_Page 2 of 112_
SUBMISSION CONTROL NO: 263995
LUC