OCTANATE

This brand name is authorized in Austria, Croatia, Ecuador, Estonia, France, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII 839MOZ74GK - ANTIHEMOPHILIC FACTOR HUMAN
 

Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.

 
Read more about Coagulation factor VIII

Medicine classification

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

ATC Group Classification
B02BD02 Coagulation factor VIII B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD02

Authorization and marketing

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

Country Identification scheme Identifier(s)
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 29216-04-10, 98-MBE-0417
EE Ravimiamet 1080076, 1080087
ES Centro de información online de medicamentos de la AEMPS 79616, 79617
FR Base de données publique des médicaments 63356814, 64343816, 67301879, 69098993
GB Medicines & Healthcare Products Regulatory Agency 399942, 399945
HR Agencija za lijekove i medicinske proizvode HR-H-067222873, HR-H-748572974
IL מִשְׂרַד הַבְּרִיאוּת 8321, 8322
LT Valstybinė vaistų kontrolės tarnyba 1004633, 1004634, 1004635, 1072376, 1072377
MT Medicines Authority MA1219/00701, MA1219/00702, MA1219/00703, MA1219/00704, MA1219/00705
NL Z-Index G-Standaard, PRK 45438, 45446, 45454
NZ Medicines and Medical Devices Safety Authority 12482, 12485, 12486
PL Rejestru Produktów Leczniczych 100237035, 100237041, 100333320, 100333336
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65351001, W65352001, W65353001, W65353002, W65354001
SG Health Sciences Authority 12512P, 12513P
TN Direction de la Pharmacie et du Médicament 10033022H, 10033023H, 10043051H, 10043052H
TR İlaç ve Tıbbi Cihaz Kurumu 8699686980113, 8699686980120
ZA Health Products Regulatory Authority 36/30.2/0346, 36/30.3/0344, 36/30.3/0345

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