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ferumoxytol (Rienso®)
Reference No. 145
Publication date:
31/07/2013
Appraisal information
ferumoxytol (Rienso®) 30 mg/ml solution for injection
Company:
Takeda UK Ltd
BNF category:
Nutrition and blood
NMG meeting date:
10/04/2013
AWMSG meeting date:
08/05/2013
Submission Type:
Full Submission
Status:
Marketing authorisation withdrawn
Advice No:
0913
Ratification by Welsh Government:
29/07/2013
Current Progress
Submission
received
NMG
meeting
AWMSG
meeting
Ratification by
Welsh Government
AWMSG advice
LICENCE WITHDRAWN. Please refer to the European Medicines Agency website for further information. Ferumoxytol (Rienso®) is recommended as an option for restricted use within NHS Wales. Ferumoxytol (Rienso®) should only be used for the intravenous treatment of iron deficiency anaemia in non-haemodialysis dependent adult chronic kidney disease patients when oral iron is ineffective or cannot be used. Ferumoxytol (Rienso®) is not recommended for use within NHS Wales outside of this subpopulation of patients. The diagnosis of iron deficiency must be based on appropriate laboratory tests.
Final Appraisal Recommendation (FAR)
Download
ferumoxytol (Rienso) 145 FAR
AWMSG Secretariat Appraisal Report (ASAR)
Download
ferumoxytol (Rienso) 145 ASAR
Clinical Expert (CE) Summary
Download
ferumoxytol (Rienso) 145 CE summary