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HRA Pharma Rare DiseasesEU/1/04/273/001

Main Information

Active SubstancesMitotane
Dosage FormTablet
Licence HolderHRA Pharma Rare Diseases
Licence NumberEU/1/04/273/001

Group Information

ATC CodeL01XX Other antineoplastic agents
L01XX23 mitotane


License statusAuthorised
Licence Issued20/05/2004
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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