Rienso
Withdrawn
This medicine's authorisation has been withdrawn
ferumoxytol
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 13 April 2015, the European Commission withdrew the marketing authorisation for Rienso (ferumoxytol) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Rienso was granted marketing authorisation in the EU on 15 June 2012 for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease. The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Rienso is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
PSUV/0015
13/04/2015
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
- Rienso
- Active substance
- Ferumoxytol
- International non-proprietary name (INN) or common name
- ferumoxytol
- Therapeutic area (MeSH)
- Anemia
- Kidney Failure, Chronic
- Anatomical therapeutic chemical (ATC) code
- B03
Pharmacotherapeutic group
Other antianemic preparationsTherapeutic indication
Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).
The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
News on Rienso
This page was last updated on