SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| NOVO SEVEN 1.2MG-VIAL | 1.2 mg | Solution for injection · Intravenous use | 1 Vial | SAR 4012.15 | Biological · Prescription | NOVO NORDISK | Withdrawn by MAH · Not Marketed |
| NOVO SEVEN 2.4MG-VIAL | 2.4 mg | Solution for injection · Intravenous use | 1 Vial | SAR 8021.15 | Biological · Prescription | NOVO NORDISK | Withdrawn by MAH · Not Marketed |
| NOVO SEVEN 4.8MG-VIAL | 4.8 mg | Solution for injection · Intravenous use | 1 Vial | SAR 16045.50 | Biological · Prescription | NOVO NORDISK | Withdrawn by MAH · Not Marketed |
EMA European Union — centrally authorised medicines
NovoSeven Novo Nordisk A/S · Authorised · authorised 23 Feb 1996 · ATC B02BD08
Therapeutic indication (EMA)
NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU); in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration; in patients with acquired haemophilia; in patients with congenital factor-VII deficiency; in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions. in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
HemAryo UGA Biopharma · Application withdrawn · ATC B02BD08
Therapeutic indication (EMA)
Treatment of bleeding episodes and for the prevention of bleeding.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| NIASTASE RT | 02417103 | 1 MG / VIAL | KIT; POWDER FOR SOLUTION · INTRAVENOUS | NOVO NORDISK CANADA INC |
| NIASTASE RT | 02417111 | 2 MG / VIAL | POWDER FOR SOLUTION; KIT · INTRAVENOUS | NOVO NORDISK CANADA INC |
| NIASTASE RT | 02417138 | 5 MG / VIAL | KIT; POWDER FOR SOLUTION · INTRAVENOUS | NOVO NORDISK CANADA INC |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.