Dynepo
Withdrawn
This medicine's authorisation has been withdrawn
epoetin delta
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 18 March 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Dynepo (epoetin delta), which had been approved for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. The marketing authorisation holder (MAH) responsible for Dynepo was Shire Pharmaceutical Contract Limited.
The European Commission was notified by letter dated 17 February 2009 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Dynepo for commercial reasons. On 17 March 2009 the European Commission issued a decision to withdraw the marketing authorisation for Dynepo.
Pursuant to this decision the European Public Assessment Report for Dynepo is updated to reflect that the marketing authorisation is no longer valid
Product information
Latest procedure affecting product information:
II/0020
29/02/2008
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
- Dynepo
- Active substance
- epoetin delta
- International non-proprietary name (INN) or common name
- epoetin delta
- Therapeutic area (MeSH)
- Kidney Failure, Chronic
- Anemia
- Anatomical therapeutic chemical (ATC) code
- B03XA
Pharmacotherapeutic group
Antianemic preparationsTherapeutic indication
Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. It may be used in patients on dialysis and in patients not on dialysis.
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