This brand name is authorized in Brazil, Canada, Japan, New Zealand, Turkey.
The drug ADYNOVATE contains one active pharmaceutical ingredient (API):
1
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UNII
5X3GF74R79 - ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ADYNOVATE Powder for injection | MPI, Generic | Health Products Regulatory Authority (ZA) |
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 |
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 | 501121010035017, 501121010035117, 501121010035217, 501121010035317, 501121010035417, 501121010035517, 501121010035617, 501121010035717, 501121010035817, 501121010035917, 501121010036017, 501121010036117, 501121010036217, 501121010036317, 501121010036417, 501121010036517, 501121010036617, 501121010036717, 501121010036817 |
| CA | Health Products and Food Branch | 02459035, 02459043, 02459051, 02459078, 02498626 |
| JP | 医薬品医療機器総合機構 | 6343446G1027, 6343446G2023, 6343446G3020, 6343446G4026, 6343446G5022, 6343446G6029 |
| NZ | Medicines and Medical Devices Safety Authority | 18284, 18285, 18286, 18287, 21010, 21011, 21012 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8681429550486, 8681429550493, 8681429550509, 8681429550516, 8681429550523 |
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