Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Thalidomide Celgene   
Auth. number : EU/1/08/443
Active substance : Thalidomide
Orphan market exclusivity for "Treatment of multiple myeloma" (based on designation EU/3/01/067) started on 18/04/2008
   10 years of market exclusivity
   This orphan market exclusivity will expire on 18/04/2018
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: L04AX02 - Thalidomide
(See WHO ATC Index)
Indication: In combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >= 65 years or ineligible for high dose chemotherapy.
Prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme
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
17/04/2008 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/823 (2008)1578 of 16/04/2008
18/04/2008 Centralised - Authorisation EMEA/H/C/823 (2008)1579 of 16/04/2008
06/06/2008 Corrigendum EMEA/H/C/823 (2008)1579 of 04/06/2008
04/07/2008 Centralised - Notification EMEA/H/C/823/N/1
Updated with Decision(2008)6214 of 20/10/2008
22/10/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/823/T/4 (2008)6214 of 20/10/2008
23/10/2008 Centralised - Variation EMEA/H/C/823/IB/5
Updated with Decision(2009)723 of 30/01/2009
28/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/823/II/2
03/02/2009 Centralised - Variation EMEA/H/C/823/II/3 (2009)723 of 30/01/2009
03/02/2009 Centralised - Variation - Decision addressed to Member States EMEA/H/C/823/II/3 (2009)722 of 30/01/2009
26/02/2009 Centralised - Variation EMEA/H/C/823/II/6 (2009)1356 of 24/02/2009
01/09/2009 Centralised - Variation EMEA/H/C/823/II/8 (2009)6717 of 27/08/2009
21/10/2009 Centralised - Variation EMEA/H/C/823/II/7 (2009)8262 of 19/10/2009
04/01/2010 Centralised - Variation EMEA/H/C/823/IA/12
Updated with Decision(2010)1813 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1813 of 15/03/2010
25/03/2010 Centralised - Variation EMEA/H/C/823/II/10, 11 (2010)2002 of 23/03/2010
12/07/2010 Centralised - Variation EMEA/H/C/823/IA/13/G
Updated with Decision(2010)6906 of 30/09/2010
05/10/2010 Centralised - Variation (2010)6906 of 30/09/2010
22/10/2010 Centralised - Variation EMEA/H/C/823/IA/16
Updated with Decision(2010)8528 of 26/11/2010
01/12/2010 Centralised - Variation EMEA/H/C/823/II/4 (2010)8528 of 26/11/2010
23/12/2010 Centralised - Variation EMEA/H/C/823/II/15 (2010)9608 of 20/12/2010
18/04/2011 Centralised - Variation EMEA/H/C/823/II/17 (2011)2864 of 18/04/2011
20/04/2011 Centralised - Variation - Decision addressed to Member States EMEA/H/C/823/II/17 (2011)2863 of 18/04/2011
16/05/2011 Centralised - Variation EMEA/H/C/823/IA/18
Updated with Decision(2011)8677 of 22/11/2011
22/06/2011 Centralised - Variation EMEA/H/C/823/IA/19
Updated with Decision(2011)8677 of 22/11/2011
30/08/2011 Corrigendum EMEA/H/C/823/II/17 (2011)6241 of 26/08/2011
24/11/2011 Centralised - Variation EMEA/H/C/823/II/23 (2011)8677 of 22/11/2011
28/08/2012 Centralised - Variation EMEA/H/C/823/II/28 (2012)6000 of 23/08/2012
13/12/2012 Centralised - Variation EMEA/H/C/823/II/27/G
Updated with Decision(2013)2108 of 09/04/2013
20/12/2012 Centralised - Renewal EMEA/H/C/823/R/30 (2012)9864 of 18/12/2012
21/02/2013 Centralised - Variation EMEA/H/C/823/II/32
Updated with Decision(2013)2108 of 09/04/2013
11/04/2013 Centralised - 2-Monthly update EMEA/H/C/823/II/33 (2013)2108 of 09/04/2013
23/07/2013 PSUSA - Modification EMEA/H/C/823/PSU/31 (2013)4807 of 19/07/2013
20/06/2014 Centralised - Variation EMEA/H/C/823/IB/41
Updated with Decision(2015)3652 of 27/05/2015
29/05/2015 Centralised - Yearly update (2015)3652 of 27/05/2015
23/11/2015 Centralised - 2-Monthly update EMEA/H/C/823/II/43 (2015)8276 of 19/11/2015
19/07/2016 PSUSA - Modification EMEA/H/C/PSUSA/2919/201510 (2016)4748 of 15/07/2016
01/02/2017 Centralised - Variation EMEA/H/C/823/IB/49