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


MVABEA



Janssen-Cilag International NVEU/1/20/1445/001

Main Information

Trade NameMVABEA
Active SubstancesMVA-BN-FILO
Dosage FormSuspension for injection
Licence HolderJanssen-Cilag International NV
Licence NumberEU/1/20/1445/001

Group Information

ATC CodeJ07BX02 Hemorrhagic Fever, Ebola

Status

License statusAuthorised
Licence Issued01/07/2020
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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