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
The drug LIBTAYO contains one active pharmaceutical ingredient (API):
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1
Cemiplimab
UNII 6QVL057INT - CEMIPLIMAB
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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 is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma. |
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 |
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 |
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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