NUCALA

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

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 more about Mepolizumab

Medication package inserts

Below package inserts are available for further reading:

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