Somavert - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn

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 of medicine:
  Somavert
• EMA product number:
  EMEA/H/C/000409
• Active substance:
  pegvisomant
• International non-proprietary name (INN) or common name:
  pegvisomant
• Therapeutic area (MeSH):
  Acromegaly
• Anatomical therapeutical chemical (ATC) code:
  H01AX01
• Marketing authorisation holder:
  Pfizer Europe MA EEIG
• Date of issue of marketing authorisation valid throughout the European Union:
  12/11/2002
• Date of withdrawal:
  16/02/2012

Dokumentai

Withdrawal assessment report for Somavert

Adopted Reference Number: EMA/271972/2012

Withdrawal letter: Somavert