OCTANINE

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

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 more about Coagulation factor IX

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
OCTANINE Powder for solution for injection	MPI, EU: SmPC	Medicines Authority (MT)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	535315030001504, 535315030001604, 535315030001704
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	162-MBE-0820, 30229-05-12, 88-MBE-0217
EE	Ravimiamet	1445262, 1445273
ES	Centro de información online de medicamentos de la AEMPS	72466
FI	Lääkealan turvallisuus- ja kehittämiskeskus	010904
HR	Agencija za lijekove i medicinske proizvode	HR-H-479880748
IL	מִשְׂרַד הַבְּרִיאוּת	7718, 7719
LT	Valstybinė vaistų kontrolės tarnyba	1005618, 1005619
MT	Medicines Authority	MA1219/00801, MA1219/00802
PL	Rejestru Produktów Leczniczych	100231624, 100231630
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65355001, W65356001
TR	İlaç ve Tıbbi Cihaz Kurumu	8699686980151, 8699686980168
ZA	Health Products Regulatory Authority	37/30.3/0645, 37/30.3/0646, 37/30.3/0647