Macugen

RSS

pegaptanib

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

Overview

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.

This EPAR was last updated on 19/08/2016

Authorisation details

Product details
Name
Macugen
Agency product number
EMEA/H/C/000620
Active substance
pegaptanib
International non-proprietary name (INN) or common name
pegaptanib
Therapeutic area (MeSH)
Wet Macular Degeneration
Anatomical therapeutic chemical (ATC) code
S01LA03
Publication details
Marketing-authorisation holder
PharmaSwiss Ceska Republika s.r.o
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
30/01/2006
Contact address
Jankovcova 1569/2c
Lighthouse
17000 Prague 7
Czech Republic

Product information

19/07/2016 Macugen - EMEA/H/C/000620 - IB/0065

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

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Assessment history

How useful was this page?

Add your rating