ENHERTU

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Finland, France, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, UK.

Active ingredients

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

1	Trastuzumab deruxtecan UNII 5384HK7574 - TRASTUZUMAB DERUXTECAN
	Trastuzumab deruxtecan is a HER2-targeted antibody-drug conjugate. The antibody is a humanised anti-HER2 IgG1 attached to deruxtecan, a topoisomerase I inhibitor (DXd) bound by a tetrapeptide-based cleavable linker. The antibody-drug conjugate is stable in plasma. The function of the antibody portion is to bind to HER2 expressed on the surface of certain tumour cells.
	Read more about Trastuzumab deruxtecan

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ENHERTU Powder for concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)
ENHERTU Powder for solution for injection	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

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

ATC Group		Classification
L01FD04	Trastuzumab deruxtecan	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FD HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
Discover more medicines within L01FD04

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	1839326, 1870747
FI	Lääkealan turvallisuus- ja kehittämiskeskus	577721
FR	Base de données publique des médicaments	63648081
GB	Medicines & Healthcare Products Regulatory Agency	394794
IL	מִשְׂרַד הַבְּרִיאוּת	8765
IT	Agenzia del Farmaco	049328014
JP	医薬品医療機器総合機構	4291452D1029
LT	Valstybinė vaistų kontrolės tarnyba	1091764
PL	Rejestru Produktów Leczniczych	100446922
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67658001
US	FDA, National Drug Code	65597-406