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Biosimilar Collaborations Ireland LimitedEU/1/18/1329/001-002

Main Information

Trade NameFulphila
Active SubstancesPegfilgrastim
Dosage FormSolution for injection in pre-filled syringe
Licence HolderBiosimilar Collaborations Ireland Limited
Licence NumberEU/1/18/1329/001-002

Group Information

ATC CodeL03AA13 pegfilgrastim


License statusAuthorised
Licence Issued20/11/2018
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


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