ADYNOVATE

This brand name is authorized in Brazil, Canada, Japan, New Zealand, Turkey

Active ingredients

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

1 Coagulation factor VIII
UNII 5X3GF74R79 - ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT

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 about Coagulation factor VIII

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ADYNOVATE Powder for injection Health Products Regulatory Authority (ZA) MPI, Generic

Medicine classification

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

ATC code Group title 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)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 501121010035017, 501121010035117, 501121010035217, 501121010035317, 501121010035417, 501121010035517, 501121010035617, 501121010035717, 501121010035817, 501121010035917, 501121010036017, 501121010036117, 501121010036217, 501121010036317, 501121010036417, 501121010036517, 501121010036617, 501121010036717, 501121010036817
Country: CA Health Products and Food Branch Identifier(s): 02459035, 02459043, 02459051, 02459078, 02498626
Country: JP 医薬品医療機器総合機構 Identifier(s): 6343446G1027, 6343446G2023, 6343446G3020, 6343446G4026, 6343446G5022, 6343446G6029
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 18284, 18285, 18286, 18287, 21010, 21011, 21012
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8681429550486, 8681429550493, 8681429550509, 8681429550516, 8681429550523

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