MYLOTARG

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

Active ingredients

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

1 Gemtuzumab ozogamicin UNII 8GZG754X6M - GEMTUZUMAB OZOGAMICIN

Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) consisting of a monoclonal antibody that is directed against the antigen CD33, an adhesion protein found on the surface of myeloid leukaemic blasts and immature normal cells of myelomonocytic lineage. The anticancer effect of gemtuzumab ozogamycin is due to the commitment of ADC to cancer cells expressing CD33, with ultimate result the induction of DNA fragment and subsequent cell cycle interruption and finally the apoptotic cell death. Read about Gemtuzumab ozogamicin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
MYLOTARG 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
L01FX02	Gemtuzumab ozogamicin	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies
Discover more medicines within L01FX02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 522721060090102
Country: CA	Health Products and Food Branch	Identifier(s): 02494388
Country: EE	Ravimiamet	Identifier(s): 1771129
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1181277001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 056196
Country: FR	Base de données publique des médicaments	Identifier(s): 60664059
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 327615
Country: HK	Department of Health Drug Office	Identifier(s): 66497
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8463
Country: IT	Agenzia del Farmaco	Identifier(s): 046485013
Country: JP	医薬品医療機器総合機構	Identifier(s): 4239400D1030
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1085544
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 21549
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100404964
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66358001
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681308271099
Country: US	FDA, National Drug Code	Identifier(s): 0008-4510