OCTANINE

This brand name is authorized in Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, Croatia, 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: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-479880748
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