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


Mounjaro



Eli Lilly Nederland B.V.EU/1/22/1685/013-015

Main Information

Trade NameMounjaro
Active SubstancesTirzepatide
Dosage FormSolution for injection in pre-filled pen
Licence HolderEli Lilly Nederland B.V.
Licence NumberEU/1/22/1685/013-015

Group Information

ATC CodeA10B BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

Status

License statusAuthorised
Licence Issued15/09/2022
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