NUWIQ

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, South Africa

Active ingredients

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

1 Coagulation factor VIII
UNII U50VWW6XH6 - SIMOCTOCOG ALFA

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  
NUWIQ Powder for solution for injection Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

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): 535317040002308, 535317040002408, 535317040002508, 535317040002608
Country: CA Health Products and Food Branch Identifier(s): 02432951, 02432978, 02432986, 02432994, 02474050, 02474069
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 39-MBE-0116, 40-MBE-0116, 41-MBE-0116, 50-MBE-0416
Country: EE Ravimiamet Identifier(s): 1657571, 1657582, 1657593, 1657605, 1768181, 1768192, 1768204, 1872873
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 114936001, 114936002, 114936003, 114936004
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 157938, 162381, 392542, 480017, 500324, 554193, 596228
Country: FR Base de données publique des médicaments Identifier(s): 60989476, 63023286, 63646237, 66102792, 67351693, 69144152, 69803752
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 280084, 280088, 280092, 280096
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 9073, 9074, 9075, 9076
Country: IT Agenzia del Farmaco Identifier(s): 043534015, 043534027, 043534039, 043534041, 043534054, 043534066, 043534078, 043534080
Country: JP 医薬品医療機器総合機構 Identifier(s): 6343457D1029, 6343457D2025, 6343457D3021, 6343457D4028, 6343457D5024, 6343457D6020, 6343457D7027
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1073923, 1073924, 1073925, 1073926, 1085359, 1085360, 1085361
Country: NL Z-Index G-Standaard Identifier(s): 14934590
Country: NL Z-Index G-Standaard, PRK Identifier(s): 127191, 127205, 127213, 127221, 167975, 167983, 167991
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 17532, 17534, 17535, 17536
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100325874, 100325880, 100325897, 100325905, 100418162, 100418185, 100418191
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W61472001, W61473001, W61474001, W61475001
Country: ZA Health Products Regulatory Authority Identifier(s): 53/30.3/0726, 53/30.3/0727, 53/30.3/0728, 53/30.3/0729

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