XYNTHA

This brand name is authorized in Brazil, Canada, Ecuador, Hong Kong, Israel, New Zealand, Singapore, South Africa

Active ingredients

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

1 Moroctocog alfa UNII P89DR4NY54 - ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

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. Read about Moroctocog alfa

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XYNTHA	Health Products and Food Branch (CA)	MPI, CA: SPM

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): 522720060088317, 522720060088417, 522720060088517
Country: CA	Health Products and Food Branch	Identifier(s): 02309483, 02309491, 02374064, 02374072, 02374080, 02374099
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 102-MBE-0617, 86-MBE-0217, 93-MBE-0417
Country: HK	Department of Health Drug Office	Identifier(s): 66834, 66835, 66836
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7493, 7494, 7495, 8131
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 11557, 14576, 8884, 8885, 8886
Country: SG	Health Sciences Authority	Identifier(s): 13791P, 13792P, 13793P, 13794P
Country: ZA	Health Products Regulatory Authority	Identifier(s): 35/8.1/0068