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Glycopyrronium bromide 200 micrograms/ml Solution for injection



EthypharmPA0549/029/001

Main Information

Trade NameGlycopyrronium bromide 200 micrograms/ml Solution for injection
Active SubstancesGlycopyrronium bromide
Dosage FormSolution for injection
Licence HolderEthypharm
Licence NumberPA0549/029/001

Group Information

ATC CodeA03AB Synthetic anticholinergics, quaternary ammonium compounds
A03AB02 glycopyrronium bromide

Status

License statusAuthorised
Licence Issued18/05/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceCommitments - to perform an additional test for detecting Particulate contamination in the finished product using Ph.Eur 2.9.20. - to perform analysis of elemental impurities in line with Q3D.
Marketing StatusNot marketed

Documents

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