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GlaxoSmithKline (Ireland) LimitedEU/1/17/1235/004-005

Main Information

Trade NameZejula
Active SubstancesNiraparid tosylate monohydrate
Dosage FormFilm-coated tablet
Licence HolderGlaxoSmithKline (Ireland) Limited
Licence NumberEU/1/17/1235/004-005

Group Information

ATC CodeL01XK02 Niraparib


License statusAuthorised
Licence Issued30/05/2022
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 Characterististics, section 4.2)
Marketing StatusUnknown


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