This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug NOVOSEVEN contains one active pharmaceutical ingredient (API):
1
|
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. |
|
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| NOVOSEVEN Powder and solvent for solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| B02BD08 | Eptacog alfa (activated) | B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors |
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 | 526601504157414, 526601505153412, 526601506151413, 526617110008407, 526617110008507, 526617110008607 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 119-MBE-1017 |
| EE | Ravimiamet | 1110991, 1111037, 1111048, 1369391, 1369403, 1369414, 1503852 |
| ES | Centro de información online de medicamentos de la AEMPS | 196006008, 196006009, 196006010 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 195122, 384599, 407218, 537074 |
| FR | Base de données publique des médicaments | 60932500, 63886517, 66390405, 69705653 |
| GB | Medicines & Healthcare Products Regulatory Agency | 138867, 138878, 138885, 186879, 223441, 223451, 223477, 223480 |
| HK | Department of Health Drug Office | 59684, 59685 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7070, 7071, 7072 |
| IT | Agenzia del Farmaco | 029447087, 029447099, 029447101, 029447113 |
| JP | 医薬品医療機器総合機構 | 6343434D6020, 6343434D7026, 6343434D8022 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1011154, 1011155, 1011156, 1071589, 1071590, 1071591, 1071592 |
| NL | Z-Index G-Standaard | 14018659, 14018667 |
| NL | Z-Index G-Standaard, PRK | 87211, 87238, 87246, 96105 |
| NZ | Medicines and Medical Devices Safety Authority | 13424, 13425, 13426, 14864 |
| PL | Rejestru Produktów Leczniczych | 100001893, 100092022, 100129334, 100238483 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W53034001, W53034002, W53036001, W53036002, W53037001, W53037002 |
| SG | Health Sciences Authority | 13933P, 13934P |
| TN | Direction de la Pharmacie et du Médicament | 5993101H, 5993102H, 5993103H, 5993104H, 5993105H, 5993106H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699676790845, 8699676790883, 8699676790890 |
| ZA | Health Products Regulatory Authority | 31/8.1/0142, 44/8.1/0550, 44/8.1/0551, 44/8.1/0552 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.