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Udenyca

6 milligram(s) Solution for injection in pre-filled syringe

ERA Consulting GmbHEU/1/18/1303/001

Main Information

Trade NameUdenyca
Active SubstancesPegfilgrastim
Strength6 milligram(s)
Dosage FormSolution for injection in pre-filled syringe
Licence HolderERA Consulting GmbH
Licence NumberEU/1/18/1303/001

Group Information

ATC CodeL03AA13 pegfilgrastim

Status

Authorised/WithdrawnAuthorised
Licence Issued21/09/2018
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, 4.2).
Marketing StatusUnknown

Documents

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