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Orgovyx



Accord Healthcare S.L.U.EU/1/22/1642/001

Main Information

Trade NameOrgovyx
Active SubstancesRelugolix
Dosage FormFilm-coated tablet
Licence HolderAccord Healthcare S.L.U.
Licence NumberEU/1/22/1642/001

Group Information

ATC CodeL02BX Other hormone antagonists and related agents

Status

License statusAuthorised
Licence Issued29/04/2022
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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