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Ogivri

420 milligram(s) Powder for concentrate for solution for infusion

Mylan S.A.S.EU/1/18/1341/002

Main Information

Trade NameOgivri
Active SubstancesTrastuzumab
Strength420 milligram(s)
Dosage FormPowder for concentrate for solution for infusion
Licence HolderMylan S.A.S.
Licence NumberEU/1/18/1341/002

Group Information

ATC CodeL01XC03 trastuzumab

Status

Authorised/WithdrawnAuthorised
Licence Issued12/12/2018
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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