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 |
L01XX42
|
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 |
Secura Bio Limited
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
28/08/2015
|
Contact address |
Secura Bio Limited |
Product information
02/06/2020 Farydak - EMEA/H/C/003725 - PSUSA/00010409/201908
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Other 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.