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


Signifor



Recordati Rare DiseasesEU/1/12/753/016-017

Main Information

Trade NameSignifor
Active SubstancesPasireotide pamoate
Dosage FormPowder and solvent for suspension for injection
Licence HolderRecordati Rare Diseases
Licence NumberEU/1/12/753/016-017

Group Information

ATC CodeH01CB Somatostatin and analogues
H01CB05 pasireotide

Status

License statusAuthorised
Licence Issued19/11/2014
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
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