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MABTHERA (rituximab), monoclonal antibodies

RARE DISEASE - New indication
Opinions on drugs - Posted on Apr 16 2015

Reason for request

Extension of indication

Minor improvement in the remission induction strategy for granulomatosis with polyangiitis and severe active microscopic polyangiitis

  

  • MABTHERA now has Marketing Authorisation, in combination with glucocorticoids, in remission induction therapy in adult patients with granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA).

  • It has a potential benefit relative to oral cyclophosphamide in patients in relapse.

  • There was no evidence of impact on fertility in patients of childbearing age.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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