The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Humira

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

AbbVie Deutschland GmbH & Co. KGEU/1/03/256/022

Main Information

Trade NameHumira
Active SubstancesAdalimumab
Strength20 milligram(s)
Dosage FormSolution for injection in pre-filled syringe
Licence HolderAbbVie Deutschland GmbH & Co. KG
Licence NumberEU/1/03/256/022

Group Information

ATC CodeL04AB Tumor necrosis factor alpha (TNF-) inhibitors
L04AB04 adalimumab

Status

Authorised/WithdrawnAuthorised
Licence Issued
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
« Back