Page contentsPage contents Key facts Decision Related medicine information Key facts Invented name Fasenra Active substance Benralizumab Therapeutic area Pneumology-allergology Decision number P/0497/2021 PIP number EMEA-001214-PIP08-21 Pharmaceutical form(s) Age appropriate dosage form for parenteral useSolution for injection Condition(s) / indication(s) Treatment of non-cystic fibrosis bronchiectasis with an eosinophilic phenotype Route(s) of administration Subcutaneous use Contact for public enquiries AstraZeneca AB (Sweden) Tel. +46 855326000E-mail: paediatrics@astrazeneca.com Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 03/12/2021 Compliance check done No Decision P/0497/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for benralizumab (Fasenra), (EMEA-001214-PIP08-21)Adopted Reference Number: EMA/622955/2021 English (EN) (242 KB - PDF)First published: 02/03/2023 View Related medicine information Fasenra Share this page