Gammaplex 10%100 mg / ml solution for infusion
- Licence status
- Withdrawn: 01/04/2021
- Active substances
- Human normal immunoglobulin
- Dosage Form
- Solution for infusion
- Licence number
- PA22765/001/001
- Licence holder
- BPL Bioproducts Laboratory GmbH
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- J06BA Immunoglobulins, normal human, J06BA02 immunoglobulins, normal human, for intravascular adm.
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Conditions Batches of plasma derived medicinal products marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC.
- Marketing availability
- Not marketed
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 06/07/2018