NanoFIX 1000 IU, 1000 IU powder and solvent for solution for injection
- Licence status
- Withdrawn: 11/01/2024
- Active substances
- Factor ix, human
- Dosage Form
- Powder and solvent for solution for injection
- Licence number
- PA2219/009/002
- Licence holder
- Octapharma (IP) SPRL
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- B02BD Blood coagulation factors, B02BD04 coagulation factor IX
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Batches of NanoFIX 1,000 IU marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of directive 2001/83/EC as amended. Final approved mock-ups for NanoFIX 1,000 IU must be submitted to the IMB for approv
- Marketing availability
- Not marketed
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 15/10/2010