FASENRA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug FASENRA contains one active pharmaceutical ingredient (API):

1 Benralizumab UNII 71492GE1FX - BENRALIZUMAB

Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa). It specifically binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα). The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation. Read about Benralizumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
FASENRA Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC
FASENRA Solution for injection	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
R03DX10		R Respiratory system → R03 Drugs for obstructive airway diseases → R03D Other systemic drugs for obstructive airway diseases → R03DX Other systemic drugs for obstructive airway diseases
Discover more medicines within R03DX10

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11504L, 11523L, 11529T, 11549W, 11830P, 11847M, 11994G, 11995H, 11996J, 11997K, 11999M, 12000N
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502318100033702
Country: CA	Health Products and Food Branch	Identifier(s): 02473232, 02496135
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 217-MBE-1021
Country: EE	Ravimiamet	Identifier(s): 1762512, 1810549
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171252001, 1171252002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 444996, 524296
Country: FR	Base de données publique des médicaments	Identifier(s): 63094493, 63562134
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 352971, 378269
Country: HK	Department of Health Drug Office	Identifier(s): 66015, 67113
Country: IE	Health Products Regulatory Authority	Identifier(s): 89108
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8969
Country: JP	医薬品医療機器総合機構	Identifier(s): 2290402G1020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1084791, 1088338
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 149446, 198714
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 20136
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100400759
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64265001, W66202001
Country: SG	Health Sciences Authority	Identifier(s): 15683P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699786950047
Country: US	FDA, National Drug Code	Identifier(s): 0310-1730, 0310-1830
Country: ZA	Health Products Regulatory Authority	Identifier(s): 54/30.1/0765