Neupopeg
Withdrawn
This medicine's authorisation has been withdrawn
pegfilgrastim
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 22 August 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Neupopeg, pegfilgrastim, which had been approved for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
The marketing authorisation holder (MAH) responsible for Neupopeg 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 Neupopeg for commercial reasons.
On 5 December 2008 the European Commission issued a decision to withdraw the marketing authorisation for Neupopeg.
Pursuant to this decision the European Public Assessment Report for Neupopeg is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0037
18/04/2008
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Neupopeg
- Active substance
- pegfilgrastim
- International non-proprietary name (INN) or common name
- pegfilgrastim
- Therapeutic area (MeSH)
- Cancer
- Anatomical therapeutic chemical (ATC) code
- L03AA13
Pharmacotherapeutic group
ImmunostimulantsTherapeutic indication
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
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