ONTRUZANT

This brand name is authorized in Austria, Australia, Brazil, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Active ingredients

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

1 Trastuzumab UNII P188ANX8CK - TRASTUZUMAB

Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). Τrastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. Read about Trastuzumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ONTRUZANT Powder for 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
L01FD01	Trastuzumab	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 L01FD01

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): 10383L, 10391X, 10401K, 10402L, 10581X, 10588G, 10589H, 10597R, 4632T, 4639E, 4650R, 4703M, 7264H, 7265J, 7266K, 7267L
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 569720010000307, 569721030000407
Country: EE	Ravimiamet	Identifier(s): 1757011
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171241001, 1171241002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 106132, 523346
Country: FR	Base de données publique des médicaments	Identifier(s): 62787822, 64346029
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 352011
Country: IT	Agenzia del Farmaco	Identifier(s): 045778014, 045778026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1084498, 1087476
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 150975, 57991
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100400073, 100428284
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66477001
Country: US	FDA, National Drug Code	Identifier(s): 0006-5033