Somavert: Withdrawal of the application to change the marketing authorisation



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

Product number
Date of issue of market authorisation valid throughout the European Union (if applicable)
International non-proprietary name (INN) or common name
  • pegvisomant
Active substance
  • Pegvisomant
Date of withdrawal
Company making the application
Pfizer Europe MA EEIG
Withdrawal type

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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