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GAZYVARO

1000 Milligram Concentrate for Soln for Inf

Roche Registration LimitedEU/1/14/937/001

Main Information

Trade NameGAZYVARO
Active SubstancesOBINUTUZUMAB
Strength1000 Milligram
Dosage FormConcentrate for Soln for Inf
Licence HolderRoche Registration Limited
Licence NumberEU/1/14/937/001

Group Information

ATC CodeL01XC15 Monoclonal antibodies

Status

Authorised/WithdrawnAuthorised
Licence Issued23/07/2014
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 LicenceMedicinal product subject 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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