The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Glycopyrronium bromide 200 micrograms/ml Solution for injection

200 microgram(s)/millilitre Solution for injection

EthypharmPA0549/029/001

Main Information

Trade NameGlycopyrronium bromide 200 micrograms/ml Solution for injection
Active SubstancesGlycopyrronium bromide
Strength200 microgram(s)/millilitre
Dosage FormSolution for injection
Licence HolderEthypharm
Licence NumberPA0549/029/001

Group Information

ATC CodeA03AB Synthetic anticholinergics, quaternary ammonium compounds
A03AB02 glycopyrronium bromide

Status

Authorised/WithdrawnAuthorised
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
« Back