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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

Status

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

Documents

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