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Azacitidine betapharm

Betapharm Arzneimittel GmbHEU/1/19/1416/001

Main Information

Trade NameAzacitidine betapharm
Active SubstancesAzacitidine
Dosage FormPowder for suspension for injection
Licence HolderBetapharm Arzneimittel GmbH
Licence NumberEU/1/19/1416/001

Group Information

ATC CodeL01BC07 azacitidine


License statusAuthorised
Licence Issued24/03/2020
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


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