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Sialanar 320 micrograms/ml oral solution

Proveca Pharma LimitedEU/1/16/1135/001

Main Information

Trade NameSialanar 320 micrograms/ml oral solution
Active SubstancesGlycopyrronium bromide
Dosage FormOral solution
Licence HolderProveca Pharma Limited
Licence NumberEU/1/16/1135/001

Group Information

ATC CodeA03AB Synthetic anticholinergics, quaternary ammonium compounds
A03AB02 glycopyrronium bromide


License statusAuthorised
Licence Issued15/09/2016
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).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - Patient

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