Somavert: Withdrawal of the application to change the marketing authorisation

pegvisomant

Overview

On 16 February 2012, Pfizer Limited officially notified the European Medicines Agency that it wished to withdraw its application to make Somavert (pegvisomant) available as 25 mg  and 30 mg powder and solvent for solution for injection. Somavert already exists as 10, 15 and 20 mg powder and solvent for solution for injection.Further information can be found in the assessment report under the tab 'All documents'.

Key facts

Name
Somavert
Product number
EMEA/H/C/000409
Date of issue of market authorisation valid throughout the European Union (if applicable)
12/11/2002
International non-proprietary name (INN) or common name
  • pegvisomant
Active substance
  • Pegvisomant
Date of withdrawal
16/02/2012
Company making the application
Pfizer Europe MA EEIG
Withdrawal type
Post-authorisation

Related content

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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