WILATE

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Ecuador, Estonia, Finland, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Spain, Tunisia, UK.

Active ingredients

The drug WILATE contains a combination of these active pharmaceutical ingredients (APIs):

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
2
UNII ZE22NE22F1 - VON WILLEBRAND FACTOR HUMAN
 

Administration of von Willebrand factor allows correction of the haemostatic abnormalities exhibited by patients who suffer from von Willebrand factor deficiency.

 
Read more about Von Willebrand factor

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 WILATE Powder and solvent for solution for injection MPI, EU: SmPC Health Products Regulatory Authority (IE)

Medicine classification

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

ATC Group Classification
B02BD06 Von Willebrand factor and coagulation factor VIII in combination B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD06

Authorization and marketing

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 535315040002107, 535315040002207, 535317070002707, 535317070002807
CA Health Products and Food Branch 02286750, 02286769
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 105-MBE-0617, 99-MBE-0517
EE Ravimiamet 1503593, 1503605
ES Centro de información online de medicamentos de la AEMPS 75625, 75648
FI Lääkealan turvallisuus- ja kehittämiskeskus 407358, 417307
GB Medicines & Healthcare Products Regulatory Agency 263058, 263068
HR Agencija za lijekove i medicinske proizvode HR-H-138328484, HR-H-758724968
IL מִשְׂרַד הַבְּרִיאוּת 7716, 7717
LT Valstybinė vaistų kontrolės tarnyba 1057510, 1057511, 1091499
MT Medicines Authority MA1219/01101, MA1219/01102
NL Z-Index G-Standaard, PRK 100404, 100412
NZ Medicines and Medical Devices Safety Authority 12483, 12484
PL Rejestru Produktów Leczniczych 100270469, 100270475
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65361001, W65362001
TN Direction de la Pharmacie et du Médicament 10043041H, 10043042H
US FDA, National Drug Code 68982-182

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