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


Modigraf



Astellas Pharma Europe BVEU/1/09/523/002

Main Information

Trade NameModigraf
Active SubstancesTacrolimus
Dosage FormGranules for oral suspension
Licence HolderAstellas Pharma Europe BV
Licence NumberEU/1/09/523/002

Group Information

ATC CodeL04AD Calcineurin inhibitors
L04AD02 tacrolimus

Status

License statusAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusMarketed

Documents

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