ADYNOVI

This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

Active ingredients

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

1 Rurioctocog alfa pegol
UNII 5X3GF74R79 - ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT

Rurioctocog alfa pegol, is a pegylated recombinant human factor VIII with an extended half-life. Rurioctocog alfa pegol is a covalent conjugate of octocog alfa consisting of 2,332 amino acids with polyethylene glycol (PEG) reagent (MW 20 kDa). The therapeutic activity of rurioctocog alfa pegol is derived from octocog alfa, which is produced by recombinant DNA technology from a Chinese hamster ovary cell line. Octocog alfa is then covalently conjugated with the PEG reagent. The PEG moiety is conjugated to octocog alfa to increase the plasma half-life.

Read about Rurioctocog alfa pegol

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ADYNOVI 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): 1762444, 1762455, 1762466, 1762477, 1762488, 1762499, 1762501, 1873111
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1171247002, 1171247006, 1171247010, 1171247014
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 144598, 189503, 524776
Country: FR Base de données publique des médicaments Identifier(s): 61598943
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 387007, 387010, 387015, 387018
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1084806, 1084807, 1084808, 1084809, 1084810, 1084811, 1084812, 1084813, 1084814, 1084815, 1084816, 1084817, 1084818, 1084819
Country: NL Z-Index G-Standaard Identifier(s): 14934590
Country: NL Z-Index G-Standaard, PRK Identifier(s): 149292, 149306, 149314, 167940
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100400720, 100400908, 100400914, 100400920, 100465053
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W66273001, W66273002, W66274001, W66274002, W66275001, W66275002, W66276001, W66276002, W66507001, W66508001, W66509001, W68368001

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