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Ulipristal Acetate Gedeon Richter

5 milligram(s) Tablet

Gedeon Richter PlcEU/1/18/1309/001-005

Main Information

Trade NameUlipristal Acetate Gedeon Richter
Active SubstancesUlipristal acetate
Strength5 milligram(s)
Dosage FormTablet
Licence HolderGedeon Richter Plc
Licence NumberEU/1/18/1309/001-005

Group Information

ATC CodeG03XB02 ulipristal

Status

Authorised/WithdrawnAuthorised
Licence Issued27/08/2018
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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