This brand name is authorized in Brazil, Canada, Ecuador, Hong Kong SAR China, Israel, New Zealand, Singapore, South Africa.
The drug XYNTHA contains one active pharmaceutical ingredient (API):
1
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UNII
P89DR4NY54 - ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT
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Moroctocog alfa is a B-domain deleted recombinant coagulation factor VIII. Moroctocog alfa has functional characteristics comparable to those of endogenous factor VIII. 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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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 | 522720060088317, 522720060088417, 522720060088517 |
| CA | Health Products and Food Branch | 02309483, 02309491, 02374064, 02374072, 02374080, 02374099 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 102-MBE-0617, 86-MBE-0217, 93-MBE-0417 |
| HK | Department of Health Drug Office | 66834, 66835, 66836 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7493, 7494, 7495, 8131 |
| NZ | Medicines and Medical Devices Safety Authority | 11557, 14576, 8884, 8885, 8886 |
| SG | Health Sciences Authority | 13791P, 13792P, 13793P, 13794P |
| ZA | Health Products Regulatory Authority | 35/8.1/0068 |
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