Macugen

Withdrawn

This medicine's authorisation has been withdrawn

pegaptanib

Overview

The marketing authorisation for Macugen has been withdrawn at the request of the marketing-authorisation holder.

Macugen : EPAR - Summary for the public

Product information

Macugen : EPAR - Product Information

Latest procedure affecting product information: IB/0065

20/07/2016

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Macugen : EPAR - All Authorised presentations

Macugen : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

Product details

• Name of medicine:
  Macugen
• Active substance:
  pegaptanib
• International non-proprietary name (INN) or common name:
  pegaptanib
• Therapeutic area (MeSH):
  Wet Macular Degeneration
• Anatomical therapeutic chemical (ATC) code:
  S01LA03

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

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

Authorisation details

• EMA product number:
  EMEA/H/C/000620
• Marketing authorisation holder:
  PharmaSwiss Ceska Republika s.r.o

  Jankovcova 1569/2c; Lighthouse; 17000 Prague 7; Czech Republic

• Marketing authorisation issued:
  31/01/2006
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Macugen : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Macugen : EPAR - Procedural steps taken before authorisation

Macugen : EPAR - Scientific Discussion