NUWIQ

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

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 more about Coagulation factor VIII

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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