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0.4 milligram(s)/millilitre Oral solution

Proveca Pharma LimitedEU/1/16/1135/001

Main Information

Trade NameSialanar
Active SubstancesGlycopyrronium bromide
Strength0.4 milligram(s)/millilitre
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


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 Status


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