Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex
- Licence status
- Active substances
- Human coagulation factor ix, Human coagulation factor ii, Human coagulation factor vii, Human coagulation factor x, Protein c, Protein s
- Dosage Form
- Powder and solvent for solution for infusion
- Licence number
- PA2219/005/002
- Licence holder
- Octapharma (IP)
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- B02BD Blood coagulation factors, B02BD01 coagulation factor IX, II, VII and X in combination
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Batches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC.
- Marketing availability
- Marketed
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 13/11/2015