Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Farydak   
Auth. number : EU/1/15/1023
Active substance : panobinostat
Orphan market exclusivity for "Treatment of multiple myeloma" (based on designation EU/3/12/1063) started on 01/09/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 01/09/2025
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX42 - Panobinostat
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/09/2015 Centralised - Authorisation EMEA/H/C/3725 (2015)6110 of 28/08/2015
25/02/2016 Centralised - Variation EMEA/H/C/3725/II/1
Updated with Decision(2017)1260 of 16/02/2017
25/02/2016 Centralised - Variation EMEA/H/C/3725/II/3
Updated with Decision(2017)1260 of 16/02/2017
23/09/2016 Centralised - Variation EMEA/H/C/3725/IB/0005/G
Updated with Decision(2017)1260 of 16/02/2017
20/02/2017 Centralised - Yearly update (2017)1260 of 16/02/2017
27/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/00010409/201608 (2017)4484 of 23/06/2017