This brand name is authorized in Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States
The drug SOLIRIS contains one active pharmaceutical ingredient (API):
1
Eculizumab
UNII A3ULP0F556 - ECULIZUMAB
|
Eculizumab is a monoclonal antibody, a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
SOLIRIS Concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | Classification |
---|---|---|
L04AJ01 | Eculizumab | L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AJ Complement inhibitors |
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): 10182X, 10183Y, 10190H, 10191J, 10192K, 10194M, 10521R, 10525Y |
Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 565517100000001 |
Country: CA | Health Products and Food Branch | Identifier(s): 02322285 |
Country: EE | Ravimiamet | Identifier(s): 1342011 |
Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 07393001 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 102268 |
Country: FR | Base de données publique des médicaments | Identifier(s): 61969188 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 118126 |
Country: HK | Department of Health Drug Office | Identifier(s): 61188 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 6725 |
Country: IT | Agenzia del Farmaco | Identifier(s): 038083010 |
Country: JP | 医薬品医療機器総合機構 | Identifier(s): 6399424A1023 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1030813 |
Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 14812 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100192746 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W68259001 |
Country: SG | Health Sciences Authority | Identifier(s): 14226P |
Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8680131470013 |
Country: US | FDA, National Drug Code | Identifier(s): 25682-001 |
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