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GlaxoSmithKline (Ireland) LimitedEU/1/17/1235/001-003

Main Information

Trade NameZejula
Active SubstancesNiraparib tosylate monohydrate
Dosage FormCapsule, hard
Licence HolderGlaxoSmithKline (Ireland) Limited
Licence NumberEU/1/17/1235/001-003

Group Information

ATC CodeL01XX Other antineoplastic agents
L01XX54 Other Antineoplastic Agents


License statusAuthorised
Licence Issued16/11/2017
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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