This is a summary of the European public assessment report (EPAR) for Visudyne. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Visudyne.
Visudyne : EPAR - Summary for the public (PDF/88.62 KB)
First published: 10/07/2007
Last updated: 24/02/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
26/07/2018 Visudyne - EMEA/H/C/000305 - II/0097
- 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
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Visudyne is indicated for the treatment of:
- adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or;
- adults with subfoveal choroidal neovascularisation secondary to pathological myopia.