This brand name is authorized in Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States
The drug ENHERTU contains one active pharmaceutical ingredient (API):
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1
Trastuzumab deruxtecan
UNII 5384HK7574 - TRASTUZUMAB DERUXTECAN
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ENHERTU Powder for solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR | |
| ENHERTU Powder for 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 |
|---|---|---|
| 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 |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EE | Ravimiamet | Identifier(s): 1839326, 1870747 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 577721 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 63648081 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 394794 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8765 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 049328014 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 4291452D1029 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1091764 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100446922 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67658001 |
| Country: US | FDA, National Drug Code | Identifier(s): 65597-406 |
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