KEYTRUDA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Pembrolizumab UNII DPT0O3T46P - PEMBROLIZUMAB

Pembrolizumab is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. Read about Pembrolizumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KEYTRUDA 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
L01FF02	Pembrolizumab	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 L01FF02

Authorization and marketing

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): 10424P, 10436G, 10475H, 10493G, 11330H, 11352L, 11492W, 11494Y, 11632F, 11646Y, 12119W, 12120X, 12121Y, 12122B, 12123C, 12124D, 12125E, 12126F, 12127G, 12128H, 12129J, 12130K
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 525517020019902
Country: CA	Health Products and Food Branch	Identifier(s): 02456869
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 127-MBE-0618
Country: EE	Ravimiamet	Identifier(s): 1691423, 1727074, 1849776
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1151024002, 1151024002IP
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 529787, 585359
Country: FR	Base de données publique des médicaments	Identifier(s): 62689214
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 343494, 377764
Country: HK	Department of Health Drug Office	Identifier(s): 64228
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7918
Country: IT	Agenzia del Farmaco	Identifier(s): 044386011, 044386023, 050864014
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291435A2025
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1077587, 1081202
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 127116, 136328
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18202
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100351618, 100386114
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64588001
Country: SG	Health Sciences Authority	Identifier(s): 14881P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699636080160
Country: US	FDA, National Drug Code	Identifier(s): 0006-3026, 0006-3029
Country: ZA	Health Products Regulatory Authority	Identifier(s): 50/30.1/0957