Farydak

RSS

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 16/07/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Marketing-authorisation holder
Novartis Europharm Limited
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
27/08/2015
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

18/06/2018 Farydak - EMEA/H/C/003725 - IA/0012

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.

Assessment history

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