AFINITOR

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

Active ingredients

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

1	Everolimus UNII 9HW64Q8G6G - EVEROLIMUS
	Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor. mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers.
	Read more about Everolimus

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
AFINITOR Tablet	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
L01EG02	Everolimus	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EG Mammalian target of rapamycin (mTOR) kinase inhibitors
Discover more medicines within L01EG02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	10131F, 10132G, 10133H, 10135K, 11254H, 11257L, 11258M, 11262R, 11267B, 11362B, 11377T, 11591C, 11592D, 11598K, 11599L, 11607X, 11608Y, 2818H, 2819J, 2985D
BR	Câmara de Regulação do Mercado de Medicamentos	526530901116312, 526530902112310, 526530903119319
CA	Health Products and Food Branch	02339501, 02339528, 02369257, 02425645, 02425653, 02425661
EE	Ravimiamet	1433281, 1433304, 1433315, 1433337, 1471373, 1471384, 1617229, 1617241
ES	Centro de información online de medicamentos de la AEMPS	09538001, 09538004
FI	Lääkealan turvallisuus- ja kehittämiskeskus	044580, 044591, 548899
FR	Base de données publique des médicaments	62142469, 64201368, 69867865
GB	Medicines & Healthcare Products Regulatory Agency	160557, 160562, 241043, 392269, 392271
HK	Department of Health Drug Office	59060, 59061, 61710, 63764, 63765, 63766
IE	Health Products Regulatory Authority	88009, 88304, 88305
IL	מִשְׂרַד הַבְּרִיאוּת	6512, 6513, 6901
JP	医薬品医療機器総合機構	4291023F1020, 4291023F2027, 4291023X1026, 4291023X2022
LT	Valstybinė vaistų kontrolės tarnyba	1050728, 1050730, 1050731, 1050733, 1070279, 1070280, 1070281, 1070282
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	028M2010
NL	Z-Index G-Standaard, PRK	100471, 92568, 92576
NZ	Medicines and Medical Devices Safety Authority	13653, 13654, 14805
PL	Rejestru Produktów Leczniczych	100211716, 100211722, 100295200
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64504001, W64504002, W64504003, W64505001, W64505002, W64505003
SG	Health Sciences Authority	13749P, 13750P, 14130P
TN	Direction de la Pharmacie et du Médicament	10283341H, 10283342H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699504011456, 8699504011463, 8699504011470, 8699504011487, 8699504011494, 8699504011500
US	FDA, National Drug Code	0078-0566, 0078-0567, 0078-0594, 0078-0620, 0078-0626, 0078-0627, 0078-0628
ZA	Health Products Regulatory Authority	43/34/1010, 43/34/1133