Macugen: Withdrawal of the application to change the marketing authorisation

pegaptanib

Overview

On 15 July 2011, Pfizer officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication, the treatment of visual impairment due to diabetic macular oedema.

Key facts

Name
Macugen
Product number
EMEA/H/C/000620
Date of issue of market authorisation valid throughout the European Union (if applicable)
31/01/2006
International non-proprietary name (INN) or common name
  • pegaptanib
Active substance
  • pegaptanib
Date of withdrawal
15/07/2011
Company making the application
PharmaSwiss Ceska Republika s.r.o
Withdrawal type
Post-authorisation

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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