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Through this approval, Benralizumab is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
The receipt of this permission paves way for the marketing of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.