This is a summary of the European public assessment report (EPAR) for Macugen. 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 Macugen.
For more information about treatment with Macugen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Macugen : EPAR - Summary for the public (PDF/57.29 KB)
First published: 31/05/2007
Last updated: 17/09/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Wet Macular Degeneration
|Anatomical therapeutic chemical (ATC) code||
PharmaSwiss Ceska Republika s.r.o
|Date of issue of marketing authorisation valid throughout the European Union||
20/07/2016 Macugen - EMEA/H/C/000620 - IB/0065
- 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.
Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).