FASENRA

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

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 more about Benralizumab

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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