ORENCIA

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

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 about Abatacept

Medication package inserts

Below package inserts are available for further reading:

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