REFACTO

This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom, South Africa

Active ingredients

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

1 Moroctocog alfa UNII 113E3Z3CJJ - MOROCTOCOG ALFA

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
REFACTO AF Powder and solvent for solution for injection	European Medicines Agency (EU)	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: EE	Ravimiamet	Identifier(s): 1197031, 1197042, 1197053, 1197064, 1529300, 1529311, 1529322, 1529333, 1617195
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 99103005, 99103006, 99103007, 99103008, 99103009
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 076667, 076680, 076691, 076702, 596871
Country: FR	Base de données publique des médicaments	Identifier(s): 60106606, 60937230, 62981909, 64968807, 66743830
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 154548, 154550, 154552, 154554, 225482, 329421, 329424, 329430, 329433
Country: IT	Agenzia del Farmaco	Identifier(s): 034421026, 034421038, 034421040, 034421053, 034421065, 034421077, 034421089, 034421091
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1030619, 1030620, 1030621, 1030622, 1060683, 1060684, 1060685, 1060686, 1068259
Country: NL	Z-Index G-Standaard	Identifier(s): 14266466, 14266474
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 100242, 100250, 100269, 107360
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 11557, 8884, 8885, 8886
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100096706, 100096712, 100250834, 100250840, 100250857
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64774001, W64775001, W64776001, W64777001, W64778001, W64779001, W64780001, W64781001
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 8013141H, 8013142H, 8013143H, 8063153H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681308274403, 8681308274410, 8681308274427, 8681308274434, 8681308277749
Country: ZA	Health Products Regulatory Authority	Identifier(s): 35/8.1/0066