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Status:	Marketing authorisation withdrawn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
Ministerial ratification:	29/07/2013

Current Progress

Submission
received

NMG
meeting

AWMSG
meeting

Ministerial
Ratification

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LICENCE WITHDRAWN.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)

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ferumoxytol (Rienso) 145 FAR

AWMSG Secretariat Appraisal Report (ASAR)

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ferumoxytol (Rienso) 145 ASAR

Clinical Expert (CE) Summary

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ferumoxytol (Rienso) 145 CE summary