Lucentis

RSS

ranibizumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 19/11/2019

Authorisation details

Product details
Name
Lucentis
Agency product number
EMEA/H/C/000715
Active substance
ranibizumab
International non-proprietary name (INN) or common name
ranibizumab
Therapeutic area (MeSH)
  • Wet Macular Degeneration
  • Macular Edema
  • Myopia, Degenerative
  • Diabetes Complications
Anatomical therapeutic chemical (ATC) code
S01LA04
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
35
Date of issue of marketing authorisation valid throughout the European Union
22/01/2007
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

21/10/2019 Lucentis - EMEA/H/C/000715 - II/0074 - II/0076

Contents

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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

Changes since initial authorisation of medicine

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