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


OLAZAX



Glenmark Pharmaceuticals s.r.o.EU/1/09/597/004

Main Information

Trade NameOLAZAX
Active SubstancesOLANZAPINE I
Dosage FormTablet
Licence HolderGlenmark Pharmaceuticals s.r.o.
Licence NumberEU/1/09/597/004

Group Information

ATC CodeN05AH03 olanzapine

Status

License statusAuthorised
Licence Issued11/12/2009
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 Status

Documents

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

Generics Information

Interchangeable List CodeIC0007-032-038
Interchangeable List DocumentPDF of Interchangeable List
« Back