KEYTRUDA

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

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 more about Pembrolizumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
KEYTRUDA Concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

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