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BENLYSTA

120 Milligram Pdr for Soln for Infusion

GlaxoSmithKline (Ireland) LimitedEU/1/11/700/001-002

Main Information

Trade NameBENLYSTA
Active SubstancesBELIMUMAB
Strength120 Milligram
Dosage FormPdr for Soln for Infusion
Licence HolderGlaxoSmithKline (Ireland) Limited
Licence NumberEU/1/11/700/001-002

Group Information

ATC CodeL04AA26 selective immunosuppressive agents

Status

Authorised/WithdrawnAuthorised
Licence Issued13/07/2011
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceSubject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)

Documents

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