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


8 milligram(s) Solution for injection in pre-filled syringe

Bausch Health Ireland LimitedEU/1/08/463/004-008

Main Information

Trade NameRelistor
Active SubstancesMethylnaltrexone bromide
Strength8 milligram(s)
Dosage FormSolution for injection in pre-filled syringe
Licence HolderBausch Health Ireland Limited
Licence NumberEU/1/08/463/004-008

Group Information

ATC CodeA06AH Peripheral opioid receptor antagonists
A06AH01 methylnaltrexone bromide


Licence Issued06/09/2010
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


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