This brand name is authorized in Canada, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, Turkey, United States
The drug ENSPRYNG contains one active pharmaceutical ingredient (API):
1
Satralizumab
UNII YB18NF020M - SATRALIZUMAB
|
Satralizumab is a recombinant humanised immunoglobuline G2 (IgG2) monoclonal antibody (mAb) that binds to soluble and membrane-bound human IL-6 receptor (IL-6R) and thereby prevents IL-6 downstream signalling through these receptors. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
ENSPRYNG Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC | |
ENSPRYNG Solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | Classification |
---|---|---|
L04AC19 | L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AC Interleukin inhibitors | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
Country: CA | Health Products and Food Branch | Identifier(s): 02499681 |
Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 189-MBE-0421 |
Country: EE | Ravimiamet | Identifier(s): 1856099 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 446332 |
Country: HK | Department of Health Drug Office | Identifier(s): 66941 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8766 |
Country: JP | 医薬品医療機器総合機構 | Identifier(s): 6399428G1024 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1092899, 1093341 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100454392 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67936001 |
Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699505951027 |
Country: US | FDA, National Drug Code | Identifier(s): 50242-007 |
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