Summary of opinion: Livmarli, 30/05/2024 Positive
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Livmarli. The marketing authorisation holder for this medicinal product is Mirum Pharmaceuticals International B.V.
The CHMP adopted a new indication as follows:
Livmarli is indicated for the treatment of:
Progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older.
For information, the full indications for LIVMARLI will be as follows:
Livmarli is indicated for the treatment of:
- Cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older,
- Progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older.1
Treatment with Livmarli should be initiated under the supervision of a physician experienced in the management of patients with cholestatic liver diseases. Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
