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. The conditions Lucentis is used to treat are:

  • the ‘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);
  • other sight problems associated with choroidal neovascularisation;
  • macular oedema (swelling of the macula) caused by diabetes;
  • macular oedema caused by occlusion (blockage) of the veins behind the retina.
This EPAR was last updated on 06/11/2018

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
30
Date of issue of marketing authorisation valid throughout the European Union
21/01/2007
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

11/07/2018 Lucentis - EMEA/H/C/000715 - II/0070

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

Changes since initial authorisation of medicine

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