NOVOSEVEN

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

Active ingredients

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

1 Eptacog alfa activated
UNII AC71R787OV - COAGULATION FACTOR VIIA RECOMBINANT HUMAN

Pharmacological doses of rFVIIa activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor. This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.

Read about Coagulation factor VIIa

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
NOVOSEVEN 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
B02BD08 Eptacog alfa (activated) B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD08

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): 526601504157414, 526601505153412, 526601506151413, 526617110008407, 526617110008507, 526617110008607
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 119-MBE-1017
Country: EE Ravimiamet Identifier(s): 1110991, 1111037, 1111048, 1369391, 1369403, 1369414, 1503852
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 196006008, 196006009, 196006010
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 195122, 384599, 407218, 537074
Country: FR Base de données publique des médicaments Identifier(s): 60932500, 63886517, 66390405, 69705653
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 138867, 138878, 138885, 186879, 223441, 223451, 223477, 223480
Country: HK Department of Health Drug Office Identifier(s): 59684, 59685
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7070, 7071, 7072
Country: IT Agenzia del Farmaco Identifier(s): 029447087, 029447099, 029447101, 029447113
Country: JP 医薬品医療機器総合機構 Identifier(s): 6343434D6020, 6343434D7026, 6343434D8022
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1011154, 1011155, 1011156, 1071589, 1071590, 1071591, 1071592
Country: NL Z-Index G-Standaard Identifier(s): 14018659, 14018667
Country: NL Z-Index G-Standaard, PRK Identifier(s): 87211, 87238, 87246, 96105
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 13424, 13425, 13426, 14864
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100001893, 100092022, 100129334, 100238483
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W53034001, W53034002, W53036001, W53036002, W53037001, W53037002
Country: SG Health Sciences Authority Identifier(s): 13933P, 13934P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 5993101H, 5993102H, 5993103H, 5993104H, 5993105H, 5993106H
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699676790845, 8699676790883, 8699676790890
Country: ZA Health Products Regulatory Authority Identifier(s): 31/8.1/0142, 44/8.1/0550, 44/8.1/0551, 44/8.1/0552

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