This brand name is authorized in Nigeria. It is also authorized in Austria, Croatia, Cyprus, Estonia, France, Germany, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Spain, Turkey.
The drug BINOCRIT contains one active pharmaceutical ingredient (API):
1
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UNII
64FS3BFH5W - EPOETIN
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Epoetin alfa is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production. Epoetin alfa is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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A6-100114 | Solution for injection | Binocrit 2,000 IU/1 mL Solution for Injection in a Pre-Filled Syringe INJ_SOL 2,000 IU/1 mL 1 mL x 6's (in Pre-filled syringes) | Clear, colourless solution for injection in a pre-filled syringe. Each mL of solution contains 2,000 IU of epoetin alfa corresponding to 16.8 micrograms per mL. A pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa Produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology | 23/02/2023 |
A6-100115 | Solution for injection | Binocrit 4,000 IU/0.4 mL Solution for Injection in a Pre-Filled Syringe INJ_SOL 4,000 IU/0.4 mL 0.4 mL x 6's (in Pre-filled syringes) | Clear, colourless solution for injection in a pre-filled syringe. Each mL of solution contains 10,000 IU of epoetin alfa corresponding to 84.0 micrograms per mL. A pre-filled syringe of 0.4 mL contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa Produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology | 23/02/2023 |
A6-100116 | Solution for injection | Binocrit 8,000 IU/0.8 mL Solution for Injection in a Pre-Filled Syringe INJ_SOL 8,000 IU/0.8 mL 0.8 mL x 6's (in Pre-filled syringes) | Clear, colourless solution for injection in a pre-filled syringe. Each mL of solution contains 10,000 IU of epoetin alfa corresponding to 84.0 micrograms per mL. A pre-filled syringe of 0.8 mL contains 8,000 international units (IU) corresponding to 67.2 micrograms epoetin alfa Produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology | 23/02/2023 |
A6-100117 | Solution for injection | Binocrit 10,000 IU/1 mL Solution for Injection in A Pre-Filled Syringe INJ_SOL 10,000 IU/1 mL 1 mL x 6's (in Pre-filled syringes) | Clear, colourless solution for injection in a pre-filled syringe | 23/02/2023 |
Below package inserts are available for further reading:
Document | Type | Information Source | |
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BINOCRIT Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
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B03XA01 | Erythropoietin | B Blood and blood forming organs → B03 Antianemic preparations → B03X Other antianemic preparations → B03XA Other antianemic preparations |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 01972254, 01972432, 01972509, 01972538, 01972774, 01972780, 01972863, 01973325, 07767874, 11314374, 11314380, 11542052, 11542075, 11691237, 11873151, 14129074, 14129080, 14129097, 14129105, 14129111, 15392655, 15895942, 16136026, 16226806, 16236259, 16236265, 16352333, 16397726, 16397732, 16632877, 16632883, 16632908, 16632914, 16757604, 16825547, 16825553, 16825576, 16878213, 16884260, 16941868, 16941874, 16941880, 16941897, 16941905, 16957355, 17155132, 17183619, 17183737, 17243882, 17276605, 17277817, 17294678, 17294684, 17294709, 17294715, 17380001, 17380018, 17411983, 17412008, 17412014, 17418809, 17439711, 17441725, 17441731, 17441748, 17528478, 17541208, 17604831, 17604848, 17604854, 17635984, 17828967 |
EE | Ravimiamet | 1317046, 1317057, 1317068, 1317079, 1317080, 1317091, 1317103, 1317114, 1317125, 1317136, 1317147, 1317158, 1317169, 1317170, 1317181, 1317192, 1397594, 1397606, 1397617, 1397628, 1454633, 1454644, 1454655, 1454666, 1454677, 1454688, 1646669, 1646670, 1646681 |
ES | Centro de información online de medicamentos de la AEMPS | 07410002, 07410004, 07410006, 07410008, 07410010, 07410012, 07410014, 07410016, 07410047, 07410049, 07410051 |
FR | Base de données publique des médicaments | 61211663, 61615809, 62200552, 62490803, 63006917, 63806058, 65612995, 67610861, 68954751, 68988159, 69174754 |
IL | מִשְׂרַד הַבְּרִיאוּת | 7699, 7700, 7701, 7702, 7703, 7704, 7705, 7706, 7707 |
LT | Valstybinė vaistų kontrolės tarnyba | 1005333, 1005334, 1005335, 1027747, 1027748, 1027749, 1027751, 1027752, 1027753, 1027755, 1027757, 1027758, 1027759, 1027760, 1027761, 1027762, 1033438, 1033439, 1033440, 1033441, 1051322, 1051323, 1051324, 1051325, 1051326, 1051327, 1059848, 1059849, 1059850, 1059851, 1059852, 1059853, 1059854, 1059855, 1059856, 1059857, 1059858, 1059859, 1059860, 1059861, 1059862, 1059863, 1059864, 1059865, 1059866, 1059867, 1059868, 1059869, 1059870, 1059871, 1059872, 1059873, 1074816, 1074817, 1074818 |
NG | Registered Drug Product Database | A6-100114, A6-100115, A6-100116, A6-100117 |
NL | Z-Index G-Standaard | 13953621, 13953648, 13953702, 13953710, 13953729, 14626640, 14626659 |
NL | Z-Index G-Standaard, PRK | 42986, 43001, 43028, 43036, 58416, 58424, 80748, 83682, 84840 |
NZ | Medicines and Medical Devices Safety Authority | 15115, 15116, 15117 |
PL | Rejestru Produktów Leczniczych | 100179958, 100179964, 100179970, 100179993, 100180000, 100180016, 100180022, 100180039, 100202290, 100202309, 100217908, 100343004, 100343010 |
RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W52282001, W52282002, W52283001, W52283002, W52284001, W52284002, W52285001, W52285002, W52286001, W52286002, W52287001, W52287002, W52288001, W52288002, W52289001, W52289002, W53308001, W53308002, W53309001, W53309002, W54776001, W54776002, W55046001, W55046002, W55048001, W55048002 |
TR | İlaç ve Tıbbi Cihaz Kurumu | 8681428950225, 8681428950232, 8681428950249, 8681428950256, 8681428950263, 8699516957315, 8699516957339, 8699516957353, 8699516957377, 8699516957391 |
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