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Rybrila 160 micrograms/ml Oral Solution



Clinigen Healthcare B.V.PA22701/001/001

Main Information

Trade NameRybrila 160 micrograms/ml Oral Solution
Active SubstancesGlycopyrronium bromide
Dosage FormOral solution
Licence HolderClinigen Healthcare B.V.
Licence NumberPA22701/001/001

Group Information

ATC CodeA03AB02 glycopyrronium bromide

Status

License statusAuthorised
Licence Issued23/07/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal 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 StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available

Educational Materials - HCP

Educational Materials - Patient

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