OCTANINE

This brand name is authorized in Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, Israel, Lithuania, Malta, Poland, Romania, Turkey, South Africa

Active ingredients

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

1 Coagulation factor IX
UNII 6U90Y1795T - COAGULATION FACTOR IX HUMAN

Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X.

Read about Coagulation factor IX

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
OCTANINE Powder for solution for injection Medicines Authority (MT) 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
B02BD04 Coagulation factor IX B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 535315030001504, 535315030001604, 535315030001704
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 162-MBE-0820, 30229-05-12, 88-MBE-0217
Country: EE Ravimiamet Identifier(s): 1445262, 1445273
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 72466
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 010904
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7718, 7719
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1005618, 1005619
Country: MT Medicines Authority Identifier(s): MA1219/00801, MA1219/00802
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100231624, 100231630
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W65355001, W65356001
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699686980151, 8699686980168
Country: ZA Health Products Regulatory Authority Identifier(s): 37/30.3/0645, 37/30.3/0646, 37/30.3/0647

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