MIRCERA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Croatia, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Italy, Japan, Lithuania, Netherlands, Nigeria, Poland, Romania, Singapore, Spain, Turkey, UK.

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 more about Epoetin beta

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
MIRCERA 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
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)
AU	Pharmaceutical Benefits Scheme	5794Y, 5795B, 5796C, 5797D, 5798E, 5799F, 5800G, 9574X, 9575Y, 9576B, 9577C, 9578D, 9579E, 9580F
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	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
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	177-MBE-0221, 28550-09-08
EE	Ravimiamet	1327621, 1327632, 1327643, 1327654, 1327665, 1327676, 1370472, 1370494, 1370506, 1370540, 1370551, 1468874, 1468885, 1468896
ES	Centro de información online de medicamentos de la AEMPS	07400008, 07400009, 07400010, 07400011, 07400012, 07400013, 07400017, 07400020
FI	Lääkealan turvallisuus- ja kehittämiskeskus	084669, 084678, 084687, 084696, 084705, 084714, 084778, 084787
FR	Base de données publique des médicaments	60070665, 63028422, 63878513, 64723850, 65058186, 65340755, 65938521, 69250216, 69579980
GB	Medicines & Healthcare Products Regulatory Agency	120447, 120454, 120459, 120462, 120468, 120474, 149643, 149647, 149650
HK	Department of Health Drug Office	56442, 56445, 56447, 56449, 56450
IT	Agenzia del Farmaco	038348013, 038348025, 038348037, 038348049, 038348052, 038348064, 038348076, 038348088, 038348090, 038348102, 038348114, 038348126, 038348138, 038348140, 038348153, 038348165, 038348177, 038348189, 038348191, 038348203, 038348215
JP	医薬品医療機器総合機構	3999432G1020, 3999432G2026, 3999432G3022, 3999432G4029, 3999432G5025, 3999432G6021, 3999432G7028, 3999432G8024
LT	Valstybinė vaistų kontrolės tarnyba	1029939, 1029942, 1029943, 1029945, 1029952, 1029956, 1034020, 1034021, 1034022, 1034023, 1034024, 1054664, 1054665, 1054666
NG	Registered Drug Product Database	A6-0106, A6-0121
Switch country to Nigeria in order to find specific presentations of MIRCERA
NL	Z-Index G-Standaard, PRK	83941, 83968, 83976, 83984, 83992, 84018, 88404, 88412, 88420
PL	Rejestru Produktów Leczniczych	100053810, 100147600, 100148828, 100156696, 100157046, 100172181, 100177014, 100177020, 100177037, 100198341, 100198364
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64389001, W64390001, W64391001, W64392001
SG	Health Sciences Authority	13529P, 13530P, 13535P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699505952222, 8699505952239
US	FDA, National Drug Code	59353-400, 59353-401, 59353-402, 59353-403, 59353-404, 59353-405, 59353-406, 59353-407, 59353-408