MYLOTARG

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

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 more about Gemtuzumab ozogamicin

Medication package inserts

Below package inserts are available for further reading:

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