Rybrila 160 micrograms / ml Oral Solution
- Licence status
- Withdrawn: 31/05/2024
- Active substances
- Glycopyrronium bromide
- Dosage Form
- Oral solution
- Licence number
- PA22701/001/001
- Licence holder
- Clinigen Healthcare B.V.
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- A03AB02 glycopyrronium bromide
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). Rybrila should be prescribed by physicians experienced in the treatment of paediatric patients with neurological disorders.
- Marketing availability
- Marketed
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 23/07/2021