ORENCIA

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

Active ingredients

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

1	Abatacept UNII 7D0YB67S97 - ABATACEPT
	Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1). Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28.
	Read more about Abatacept

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ORENCIA Powder for concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)
ORENCIA Solution for injection	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
L04AA24	Abatacept	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AA Selective immunosuppressants
Discover more medicines within L04AA24

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	11684Y, 11693K, 1220F, 1221G, 5605B, 9621J
BR	Câmara de Regulação do Mercado de Medicamentos	505107701157215, 505113030019605, 505113100020505
CA	Health Products and Food Branch	02282097, 02402475
EE	Ravimiamet	1294792, 1294804, 1294815, 1595729, 1595730, 1595741, 1636310, 1699308, 1699319, 1792627, 1792661
ES	Centro de información online de medicamentos de la AEMPS	07389001, 07389008, 107389011
FI	Lääkealan turvallisuus- ja kehittämiskeskus	068563, 086407, 395057
FR	Base de données publique des médicaments	60627865, 61070305, 61927584, 63044647, 69256710
GB	Medicines & Healthcare Products Regulatory Agency	117541, 216997, 297472, 372170, 372173
HK	Department of Health Drug Office	58513, 61501, 61905
IE	Health Products Regulatory Authority	88555, 88782
IL	מִשְׂרַד הַבְּרִיאוּת	6520, 7117
IT	Agenzia del Farmaco	037989011, 037989023, 037989035, 037989047, 037989050, 037989062, 037989074, 037989086, 037989098, 037989100, 037989112, 037989124, 037989136, 037989148
JP	医薬品医療機器総合機構	3999429G1028, 3999429G2024
LT	Valstybinė vaistų kontrolės tarnyba	1030157, 1030158, 1030159, 1068120, 1068123, 1068124, 1068125, 1068126, 1068127, 1071608, 1079166, 1079167, 1087554, 1087555
NL	Z-Index G-Standaard	15739473
NL	Z-Index G-Standaard, PRK	103632, 128848, 201537, 201545, 83569
NZ	Medicines and Medical Devices Safety Authority	12809, 14723
PL	Rejestru Produktów Leczniczych	100157000, 100285235, 100462482, 100462490
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65570001, W65570002, W65570003, W65571001, W65571002, W65571003, W65571004, W65571005, W65571006, W65572001, W65572002
SG	Health Sciences Authority	13553P, 14387P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699726266405, 8699726950601
US	FDA, National Drug Code	0003-2187, 0003-2188, 0003-2814, 0003-2818
ZA	Health Products Regulatory Authority	41/3.1/1061, 47/3.1/0467