Nespo

Withdrawn

This medicine's authorisation has been withdrawn

darbepoetin alfa

Overview

On 8 June 2001 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Nespo, darbepoetin alfa, which had been approved for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients and treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. 

The marketing authorisation holder (MAH) responsible for Nespo was Dompé Biotec S.p.A. The European Commission was notified by letter dated 10 November 2008 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Nespo for commercial reasons. 

On 5 December 2008 the European Commission issued a decision to withdraw the marketing authorisation for Nespo. 

Pursuant to this decision the European Public Assessment Report for Nespo is updated to reflect that the marketing authorisation is no longer valid.

Nespo : EPAR - Summary for the public

Product information

Nespo : EPAR - Product Information

Nespo : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nespo
• Active substance:
  darbepoetin alfa
• International non-proprietary name (INN) or common name:
  darbepoetin alfa
• Therapeutic area (MeSH):
  • Kidney Failure, Chronic
  • Anemia
  • Cancer
• Anatomical therapeutic chemical (ATC) code:
  B03XA02

Pharmacotherapeutic group

Antianemic preparations

Therapeutic indication

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.
Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Authorisation details

• EMA product number:
  EMEA/H/C/000333
• Marketing authorisation holder:
  Dompé Biotec S.p.A.

  Via San Martino 12; I-20122 Milan; Italy

• Marketing authorisation issued:
  08/06/2001
• Withdrawal of marketing authorisation:
  05/12/2008
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

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

Nespo : EPAR - Steps taken after authorisation when a cutoff date has been used

Nespo-H-C-333-X-43 : EPAR - Assessment Report - Variation

Nespo-H-C-333-II-36 : EPAR - Scientific Discussion - Variation

Adopted

Nespo-H-C-333-II-29 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Nespo : EPAR - Procedural steps taken before authorisation

Nespo : EPAR - Scientific Discussion