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


RoActemra



Roche Registration GmbHEU/1/08/492/007

Main Information

Trade NameRoActemra
Active SubstancesTocilizumab
Dosage FormSolution for injection in pre-filled syringe
Licence HolderRoche Registration GmbH
Licence NumberEU/1/08/492/007

Group Information

ATC CodeL04AC Interleukin inhibitors
L04AC07 tocilizumab

Status

License statusAuthorised
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 products 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

Educational Materials - Patient

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