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


Noletil XL 200mg Prolonged-release Tablets

200 milligram(s) Prolonged-release tablet

Bluefish Pharmaceuticals ABPA1436/024/001

Main Information

Trade NameNoletil XL 200mg Prolonged-release Tablets
Active SubstancesQuetiapine hemifumarate
Strength200 milligram(s)
Dosage FormProlonged-release tablet
Licence HolderBluefish Pharmaceuticals AB
Licence NumberPA1436/024/001

Group Information

ATC CodeN05AH Diazepines, oxazepines, thiazepines and oxepines
N05AH04 quetiapine

Status

Authorised/WithdrawnAuthorised
Licence Issued23/11/2012
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 StatusNot marketed

Documents

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

Generics Information

Interchangeable List CodeIC0019-067-024
Interchangeable List DocumentPDF of Interchangeable List
« Back