NUCALA

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

Active ingredients

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

1 Mepolizumab UNII 90Z2UF0E52 - MEPOLIZUMAB

Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), which targets human interleukin-5 (IL-5) with high affinity and specificity. IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation and survival of eosinophils. Mepolizumab is indicated as an add-on treatment for severe refractory eosinophilic asthma. Read about Mepolizumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
NUCALA Powder for solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
R03DX09		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 R03DX09

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): 10980X, 10996R, 11003D, 11014Q, 11829N, 11839D, 12007Y, 12021Q, 12043W, 12051G, 12052H, 12064Y
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 510618010059201, 510620110056207, 510620110056307
Country: CA	Health Products and Food Branch	Identifier(s): 02449781, 02492989, 02492997
Country: EE	Ravimiamet	Identifier(s): 1706105, 1706116, 1802540, 1802551, 1802562, 1802573, 1882515
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1151043001, 1151043003, 1151043005
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 176663, 373173, 437922
Country: FR	Base de données publique des médicaments	Identifier(s): 63236206, 65864619, 66719612
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 311914, 375020, 375026
Country: HK	Department of Health Drug Office	Identifier(s): 65070, 66838, 66839
Country: IE	Health Products Regulatory Authority	Identifier(s): 89101, 89102
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7972, 8934
Country: IT	Agenzia del Farmaco	Identifier(s): 044648018, 044648020, 044648032, 044648044, 044648057, 044648069, 044648071, 044648083, 044648095, 044648107
Country: JP	医薬品医療機器総合機構	Identifier(s): 2290401D1020, 2290401G1026, 2290401G2022, 2290401G3029
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1079067, 1079068, 1088323, 1088324, 1088325, 1088326
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 129836
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18235, 21378, 21475
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100357414, 100422198, 100422206, 100468599
Country: SG	Health Sciences Authority	Identifier(s): 15396P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699522779987, 8699522779994, 8699522958528, 8699522958535, 8699522958542, 8699522958559
Country: US	FDA, National Drug Code	Identifier(s): 0173-0881, 0173-0892