Farydak
panobinostat
Table of contents
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.
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Farydak : EPAR - Summary for the public (PDF/78.67 KB)
First published: 11/09/2015
Last updated: 11/09/2015 -
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Farydak : EPAR - Risk-management-plan summary (PDF/148.21 KB)
First published: 11/09/2015
Last updated: 19/05/2020
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
|
Orphan |
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 | |
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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 |
Product information
24/04/2023 Farydak - EMEA/H/C/003725 - T/0027
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.