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Orserdu



Stemline Therapeutics B.V.EU/1/23/1757/002

Main Information

Trade NameOrserdu
Active SubstancesElacestrant Dihydrochloride
Dosage FormFilm-coated tablet
Licence HolderStemline Therapeutics B.V.
Licence NumberEU/1/23/1757/002

Group Information

ATC CodeL02BA Anti-estrogens
L02BA04 elacestrant

Status

License statusAuthorised
Licence Issued15/09/2023
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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