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


Noxafil 100 mg gastro-resistant tablets



Merck Sharp & Dohme BV,EU/1/05/320/002-003

Main Information

Trade NameNoxafil 100 mg gastro-resistant tablets
Active SubstancesPosaconazole
Dosage FormGastro-resistant tablet
Licence HolderMerck Sharp & Dohme BV,
Licence NumberEU/1/05/320/002-003

Group Information

ATC CodeJ02AC Triazole derivatives
J02AC04 posaconazole

Status

License statusAuthorised
Licence Issued23/04/2014
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

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

Generics Information

Interchangeable List CodeIC0126-024-005
Interchangeable List DocumentPDF of Interchangeable List
« Back