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fingolimod (Gilenya®)


Reference No. 2777


Appraisal information

fingolimod (Gilenya®) 0.25 mg hard capsule
fingolimod (Gilenya®) 0.5 mg hard capsule


Company: Novartis Pharmaceuticals UK Ltd
BNF category: Malignant disease and immunosupression
NMG meeting date: 03/04/2019
AWMSG meeting date: 15/05/2019
   
   
Submission Type: Limited Submission
Status: In progress
Advice No: Not available
Ratification by Welsh Government: Not available

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ratification by
Welsh Government

Indication

A single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of paediatric patients aged 10-17 years of age: for patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI
AWMSG Secretariat Appraisal Report (ASAR)
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Preliminary Appraisal Recommendation (PAR)
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Company Response to the Preliminary Appraisal Recommendation (CR PAR)
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