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


Duloxetine Mylan

30 milligram(s) Gastro-resistant capsule

Mylan S.A.S.EU/1/15/1010/01-010

Main Information

Trade NameDuloxetine Mylan
Active SubstancesDuloxetine hydrochloride
Strength30 milligram(s)
Dosage FormGastro-resistant capsule
Licence HolderMylan S.A.S.
Licence NumberEU/1/15/1010/01-010

Group Information

ATC CodeN06A ANTIDEPRESSANTS

Status

Authorised/WithdrawnAuthorised
Licence Issued19/06/2015
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

Documents

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

Generics Information

Interchangeable List CodeIC0091-033-006
Interchangeable List DocumentPDF of Interchangeable List
« Back