AFSTYLA

This brand name is authorized in Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, 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 about Lonoctocog alfa

Medication package inserts

Below package inserts are available for further reading:

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