Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Imnovid   
Auth. number : EU/1/13/850
Active substance : Pomalidomide
Orphan market exclusivity for "Treatment of multiple myeloma" (based on designation EU/3/09/672) started on 08/08/2013
   10 years of market exclusivity
   This orphan market exclusivity will expire on 08/08/2023
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AX - Other immunosuppressive agents
Chemical substance: L04AX06 - Pomalidomide
(See WHO ATC Index)
Indication: Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Marketing Authorisation Holder: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, 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
08/08/2013 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2682 (2013)5290 of 05/08/2013
08/08/2013 Centralised - Authorisation EMEA/H/C/2682 (2013)5289 of 05/08/2013
27/08/2013 Centralised - Variation EMEA/H/C/2682/IAin/1
Updated with Decision(2014)6188 of 26/08/2014
09/09/2013 Corrigendum (2013)5786 of 05/09/2013
24/07/2014 Centralised - Variation EMEA/H/C/2682/II/3
Updated with Decision(2014)6188 of 26/08/2014
28/07/2014 Centralised - Variation EMEA/H/C/2682/IB/7/G
Updated with Decision(2014)6188 of 26/08/2014
28/08/2014 Centralised - Yearly update (2014)6188 of 26/08/2014
20/11/2014 Centralised - Variation EMEA/H/C/2682/II/5
Updated with Decision(2015)3658 of 27/05/2015
21/11/2014 PSUSA - Modification EMEA/H/C/2682/PSUV/6 (2014)8897 of 19/11/2014
29/05/2015 PSUSA - Modification EMEA/H/C/2682/PSUSA/10127/201408 (2015)3658 of 27/05/2015
23/11/2015 PSUSA - Modification EMEA/H/C/2682/10127/201502 (2015)8291 of 19/11/2015
31/05/2016 PSUSA - Modification EMEA/H/C/2682/PSUSA/10127/201508 (2016)3322 of 26/05/2016
28/06/2016 Centralised - 2-Monthly update EMEA/H/C/2682/II/0016/G (2016)4090 of 24/06/2016
06/07/2016 Centralised - Variation EMEA/H/C/2682/IB/0019
02/08/2016 Centralised - 2-Monthly update EMEA/H/C/2682/II/0018 (2016)5079 of 29/07/2016
13/09/2016 Centralised - Variation EMEA/H/C/2682/IB/0022