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

Arsenic Trioxide Mylan

Mylan IRE Healthcare LimitedEU/1/20/1427/001-002

Main Information

Trade NameArsenic Trioxide Mylan
Active SubstancesArsenic Trioxide
Dosage FormConcentrate for solution for infusion
Licence HolderMylan IRE Healthcare Limited
Licence NumberEU/1/20/1427/001-002

Group Information

ATC CodeL01XX27 arsenic trioxide


License statusAuthorised
Licence Issued01/04/2020
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


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