LIBTAYO

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Active ingredients

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

1 Cemiplimab
UNII 6QVL057INT - CEMIPLIMAB

Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2. Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.

Read about Cemiplimab

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
LIBTAYO 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
L01FF06 Cemiplimab L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FF PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
Discover more medicines within L01FF06

Authorization and marketing

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

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 576719080000001
Country: CA Health Products and Food Branch Identifier(s): 02487144, 02487152
Country: EE Ravimiamet Identifier(s): 1799129
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 109464
Country: FR Base de données publique des médicaments Identifier(s): 61660291
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 374455
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8512
Country: IT Agenzia del Farmaco Identifier(s): 048070015
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291466A1024
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1088128
Country: NL Z-Index G-Standaard, PRK Identifier(s): 198749
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100422755
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W66237001
Country: US FDA, National Drug Code Identifier(s): 61755-008

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