This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States
The drug LEMTRADA contains one active pharmaceutical ingredient (API):
1
Alemtuzumab
UNII 3A189DH42V - ALEMTUZUMAB
|
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes. Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
LEMTRADA 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 |
---|---|---|
L04AG06 | Alemtuzumab | L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies |
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): 10228H, 10232M, 10243D, 10246G |
Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 576720030060017 |
Country: CA | Health Products and Food Branch | Identifier(s): 02418320 |
Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 21-MBE-0415 |
Country: EE | Ravimiamet | Identifier(s): 1625969 |
Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 112869001 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 165070 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 245619 |
Country: HK | Department of Health Drug Office | Identifier(s): 64543 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 7616 |
Country: IT | Agenzia del Farmaco | Identifier(s): 043027010 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1071216 |
Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 99546 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100304487 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W64873001 |
Country: SG | Health Sciences Authority | Identifier(s): 14919P |
Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699809779228 |
Country: US | FDA, National Drug Code | Identifier(s): 58468-0200 |
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