SPEVIGO

This brand name is authorized in Austria, Estonia, Spain, France, Croatia, Italy, Japan, Lithuania, Romania, United States

Active ingredients

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

1 Spesolimab UNII 5IB2J79MCX - SPESOLIMAB

Spesolimab is a humanised antagonistic monoclonal immunoglobulin G1 (IgG1) antibody blocking human interleukin 36 receptor (IL36R) signalling. Binding of spesolimab to IL36R prevents the subsequent activation of IL36R by its ligands (IL36 α, β and γ) and downstream activation of pro-inflammatory pathways. Read about Spesolimab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SPEVIGO Concentrate for solution for infusion	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
L04AC22		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AC Interleukin inhibitors
Discover more medicines within L04AC22

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1896802
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1221688001
Country: FR	Base de données publique des médicaments	Identifier(s): 68300246
Country: IT	Agenzia del Farmaco	Identifier(s): 050464015
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999466A1026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1096136
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W69453001
Country: US	FDA, National Drug Code	Identifier(s): 0597-0035