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


Envarsus



Chiesi Farmaceutici S.p.A.EU/1/14/35/007-009

Main Information

Trade NameEnvarsus
Active SubstancesTacrolimus monohydrate
Dosage FormProlonged-release tablet
Licence HolderChiesi Farmaceutici S.p.A.
Licence NumberEU/1/14/35/007-009

Group Information

ATC CodeL04AD Calcineurin inhibitors
L04AD02 tacrolimus

Status

License statusAuthorised
Licence Issued18/07/2014
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
« Back