Lucentis
ranibizumab
Table of contents
Overview
Lucentis is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces. In adults, Lucentis is used to treat:
- ‘wet’ form of age-related macular degeneration (AMD). The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);
- macular oedema (swelling of the macula) caused by diabetes or by occlusion (blockage) of the veins behind the retina;
- proliferative diabetic retinopathy (growth of abnormal tiny blood vessels in the eye, associated with diabetes);
- other sight problems associated with choroidal neovascularisation.
Lucentis is also used in preterm infants to treat retinopathy of prematurity, an eye condition that can occur when a baby is born too early and blood vessels in the eye do not develop normally, causing damage to the retina. It is only used for specific stages of the disease (zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) as well as the rapidly progressing, severe form of the disease called aggressive posterior retinopathy disease).
Lucentis contains the active substance ranibizumab.
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List item
Lucentis : EPAR - Medicine overview (PDF/90.1 KB)
First published: 12/12/2008
Last updated: 06/11/2018
EMA/554038/2018 -
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List item
Lucentis : EPAR - Risk-management-plan summary (PDF/66.39 KB)
First published: 31/08/2018
Last updated: 05/11/2019
Authorisation details
Product details | |
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Name |
Lucentis
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Agency product number |
EMEA/H/C/000715
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Active substance |
ranibizumab
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International non-proprietary name (INN) or common name |
ranibizumab
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
S01LA04
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
37
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Date of issue of marketing authorisation valid throughout the European Union |
22/01/2007
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Contact address |
Product information
05/08/2020 Lucentis - EMEA/H/C/000715 - IA/0087
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Ophthalmologicals
Therapeutic indication
Lucentis is indicated in adults for:
- The treatment of neovascular (wet) age-related macular degeneration (AMD)
- The treatment of visual impairment due to choroidal neovascularisation (CNV)
- The treatment of visual impairment due to diabetic macular oedema (DME)
- The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
Assessment history
News
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20/09/2019
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20/09/2019
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26/07/2019
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 201614/10/2016
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31/05/2013