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rituximab (MabThera®)

 

Following non-submission

AWMSG advice

Status: Not endorsed (Statement of Advice)

In the absence of a submission from the holder of the marketing authorisation, rituximab (MabThera®) cannot be endorsed for use within NHS Wales in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

 Statement of Advice (SOA): rituximab (MabThera®) 4446 (PDF, 111Kb)

Medicine details

Medicine name rituximab (MabThera®)
Formulation 100 mg and 500 mg concentrate for solution for infusion
Reference number 4446
Indication

In combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA)

Company Roche Products Ltd
BNF chapter Malignant disease & immunosuppression
Assessment type Non-submission
Status Not endorsed (Statement of Advice)
Date of issue 24/06/2021
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