My HPRA: Register

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


Revatio



Upjohn EESVEU/1/05/318/001

Main Information

Trade NameRevatio
Active SubstancesSildenafil
Dosage FormFilm-coated tablet
Licence HolderUpjohn EESV
Licence NumberEU/1/05/318/001

Group Information

ATC CodeG04BE Drugs used in erectile dysfunction
G04BE03 sildenafil

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 StatusUnknown

Documents

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

Generics Information

Interchangeable ListSildenafil 20mg Film-coated Tablets
Interchangeable List CodeIC0063-003-003
Interchangeable List DocumentPDF of Interchangeable List
« Back
Follow medicine

Print