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


Roaccutane 20 mg soft capsules



PCO Manufacturing Ltd.PPA0465/493/001

Main Information

Trade NameRoaccutane 20 mg soft capsules
Active SubstancesIsotretinoin
Dosage FormCapsule, soft
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/493/001

Group Information

ATC CodeD10BA Retinoids for treatment of acne
D10BA01 isotretinoin

Status

License statusWithdrawn
Withdrawn Date31/12/2023
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 CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back