Farydak

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panobinostat

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Farydak. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Farydak.

For practical information about using Farydak, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 16/05/2023

Authorisation details

Product details
Name
Farydak
Agency product number
EMEA/H/C/003725
Active substance
panobinostat lactate anhydrous
International non-proprietary name (INN) or common name
panobinostat
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XH03
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
zr pharma& GmbH
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
28/08/2015
Contact address

Hietzinger Hauptstrasse 37 
1130 Wien 
Austria

Product information

24/04/2023 Farydak - EMEA/H/C/003725 - T/0027

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

Assessment history

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