AFSTYLA

This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, Spain, Turkey.

Active ingredients

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

1	Lonoctocog alfa UNII VQ723R7O8R - LONOCTOCOG ALFA
	Lonoctocog alfa is a recombinant human protein that replaces the missing coagulation factor VIII needed for effective hemostasis. Lonoctocog alfa is a single polypeptide chain with a truncated B-domain that allows for a covalent bridge to link the factor VIII heavy and light chains. Lonoctocog alfa has demonstrated a higher VWF affinity relative to full-length rFVIII. VWF stabilizes factor VIII and protects it from degradation. Activated lonoctocog alfa has an amino acid sequence identical to endogenous FVIIIa.
	Read more about Lonoctocog alfa

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
AFSTYLA 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)
BR	Câmara de Regulação do Mercado de Medicamentos	502620090009407, 502620090009507, 502620090009607, 502620090009707, 502620090009807
EE	Ravimiamet	1736377, 1736388, 1736399, 1736401, 1736412, 1736423, 1736434
ES	Centro de información online de medicamentos de la AEMPS	1161158001, 1161158002, 1161158003, 1161158005
FI	Lääkealan turvallisuus- ja kehittämiskeskus	070563, 076792, 135654, 137797, 167588, 444932, 533147
FR	Base de données publique des médicaments	60944716, 61411315, 61906519, 64280351, 64477690, 66216027, 67710662
HK	Department of Health Drug Office	66199, 66200, 66201, 66202
JP	医薬品医療機器総合機構	6343450D1027, 6343450D2023, 6343450D3020, 6343450D4026, 6343450D5022, 6343450D6029, 6343450D7025
LT	Valstybinė vaistų kontrolės tarnyba	1082000, 1082001, 1082002, 1082003, 1082004, 1082005, 1082006
NL	Z-Index G-Standaard, PRK	139254, 139262, 139270, 139289, 139297, 139300, 139319
NZ	Medicines and Medical Devices Safety Authority	18984, 19053, 19054, 19055, 19056, 19057, 19058
PL	Rejestru Produktów Leczniczych	100383890, 100383908, 100383914, 100383920, 100383937, 100383943, 100383950
SG	Health Sciences Authority	15820P, 15821P, 15822P, 15823P, 15824P
TR	İlaç ve Tıbbi Cihaz Kurumu	8681624980293, 8681624980309, 8681624980323