MIRCERA

This brand name is authorized in Austria, Australia, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States

Active ingredients

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

1 Epoetin beta UNII LR3UXN0193 - METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Epoetin beta stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow. Epoetin beta is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin. Read about Epoetin beta

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
MIRCERA Solution for injection	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
B03XA03	Methoxy polyethylene glycol-epoetin beta	B Blood and blood forming organs → B03 Antianemic preparations → B03X Other antianemic preparations → B03XA Other antianemic preparations
Discover more medicines within B03XA03

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): 5794Y, 5795B, 5796C, 5797D, 5798E, 5799F, 5800G, 9574X, 9575Y, 9576B, 9577C, 9578D, 9579E, 9580F
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 01151333, 01151445, 01151557, 01151586, 04761196, 04761291, 04761322, 04761345, 04761368, 04761374, 04959372, 04963296, 05379300, 05379317, 05379323, 05379346, 05379352, 05379369, 05379375, 05379381, 05451167, 05451173, 05484540, 05484557, 05484563, 06126038, 06126050, 06126073, 06558720, 07260307, 07773082, 07773099, 07773107, 08472158, 08472164, 08472170, 08472336, 08472402, 08472425, 08472431, 08472448, 08472454, 09202277, 09202283, 09206453, 09206476, 09234231, 09234248, 09234277, 09234308, 09313568, 09313597, 09393024, 09393030, 09423713, 09460849, 09460861, 09537316, 09785913, 09785942, 09902394, 10400077, 10400083, 10407375, 10552321, 10552338, 10628337, 10712552, 10753083, 11073870, 11240463, 11240486, 11240492, 11240500, 11367790, 11523184, 11536548, 11536554, 11536560, 11536577, 11536583, 11557266, 11557295, 11557303, 11557332, 11557349, 11557355, 11614337, 11614343, 11614366, 11614372, 11653685, 11883327, 12389262, 12396121, 12397184, 12397988, 12399131, 12405067, 12405073, 12405096, 12405104, 12405110, 12405127, 12407818, 12412653, 12452434, 12452440, 12456188, 12596305, 12596311, 13235408, 13333915, 13348294, 13631067, 13631073, 13631096, 13696090, 13814951, 13814968, 13814974, 13971774, 13971780, 14032529, 14056725, 14145647, 14409773, 16037040, 16037057, 16037063, 16037086, 16037092, 16037100, 16037117, 16037123, 16529659, 16665144, 16861075, 17601502, 17887013
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 177-MBE-0221, 28550-09-08
Country: EE	Ravimiamet	Identifier(s): 1327621, 1327632, 1327643, 1327654, 1327665, 1327676, 1370472, 1370494, 1370506, 1370540, 1370551, 1468874, 1468885, 1468896
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 07400008, 07400009, 07400010, 07400011, 07400012, 07400013, 07400017, 07400020
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 084669, 084678, 084687, 084696, 084705, 084714, 084778, 084787
Country: FR	Base de données publique des médicaments	Identifier(s): 60070665, 63028422, 63878513, 64723850, 65058186, 65340755, 65938521, 69250216, 69579980
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 120447, 120454, 120459, 120462, 120468, 120474, 149643, 149647, 149650
Country: HK	Department of Health Drug Office	Identifier(s): 56442, 56445, 56447, 56449, 56450
Country: IT	Agenzia del Farmaco	Identifier(s): 038348013, 038348025, 038348037, 038348049, 038348052, 038348064, 038348076, 038348088, 038348090, 038348102, 038348114, 038348126, 038348138, 038348140, 038348153, 038348165, 038348177, 038348189, 038348191, 038348203, 038348215
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999432G1020, 3999432G2026, 3999432G3022, 3999432G4029, 3999432G5025, 3999432G6021, 3999432G7028, 3999432G8024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1029939, 1029942, 1029943, 1029945, 1029952, 1029956, 1034020, 1034021, 1034022, 1034023, 1034024, 1054664, 1054665, 1054666
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 83941, 83968, 83976, 83984, 83992, 84018, 88404, 88412, 88420
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100053810, 100147600, 100148828, 100156696, 100157046, 100172181, 100177014, 100177020, 100177037, 100198341, 100198364
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64389001, W64390001, W64391001, W64392001
Country: SG	Health Sciences Authority	Identifier(s): 13529P, 13530P, 13535P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505952222, 8699505952239
Country: US	FDA, National Drug Code	Identifier(s): 59353-400, 59353-401, 59353-402, 59353-403, 59353-404, 59353-405, 59353-406, 59353-407, 59353-408