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Hulio



Biosimilar Collaborations Ireland LimitedEU/1/18/1319/001-007

Main Information

Trade NameHulio
Active SubstancesAdalimumab
Dosage FormSolution for injection
Licence HolderBiosimilar Collaborations Ireland Limited
Licence NumberEU/1/18/1319/001-007

Group Information

ATC CodeL04AB04 adalimumab

Status

License statusAuthorised
Licence Issued17/09/2018
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, 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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