REFACTO

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

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 more about Moroctocog alfa

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
REFACTO AF Powder and solvent for solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)

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