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


Opatanol



Novartis Europharm LimitedEU/1/02/217/002

Main Information

Trade NameOpatanol
Active SubstancesOlopatadine hydrochloride
Dosage FormEye drops, solution
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/02/217/002

Group Information

ATC CodeS01GX Other antiallergics
S01GX09 olopatadine

Status

License statusAuthorised
Licence Issued17/05/2002
Legal statusProduct subject to prescription which may be renewed (B)
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
« Back