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Azacitidine Mylan

25 milligram(s)/millilitre Powder for suspension for injection

Mylan IRE Healthcare LimitedEU/1/20/1426/001-002

Main Information

Trade NameAzacitidine Mylan
Active SubstancesAzacitidine
Strength25 milligram(s)/millilitre
Dosage FormPowder for suspension for injection
Licence HolderMylan IRE Healthcare Limited
Licence NumberEU/1/20/1426/001-002

Group Information

ATC CodeL01BC07 azacitidine

Status

Authorised/WithdrawnAuthorised
Licence Issued27/03/2020
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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