Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Revlimid   
Auth. number : EU/1/07/391
INN : Lenalidomide
Orphan status based on designation EU/3/03/177 added on 19/06/2007
Orphan status based on designation EU/3/04/192 added on 17/06/2013
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: L04AX04 - Lenalidomide
(See WHO ATC Index)
Indication: Multiple myeloma
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Myelodysplastic syndromes
Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
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
18/06/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/717 (2007)3033 of 14/06/2007
19/06/2007 Centralised - Authorisation EMEA/H/C/717 (2007)3032 of 14/06/2007
13/12/2007 Centralised - Variation EMEA/H/C/717/IA/3
Updated with Decision(2008)1173 of 18/03/2008
23/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IB/4
19/03/2008 Centralised - Variation EMEA/H/C/717/II/2 (2008)1172 of 18/03/2008
20/03/2008 Centralised - Variation EMEA/H/C/717/II/2 (2008)1173 of 18/03/2008
23/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IA/6
29/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IB/7
21/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IA/9
30/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IB/10
30/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IB/11
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/II/12
04/08/2008 Centralised - Variation EMEA/H/C/717/II/8 (2008)4280 of 31/07/2008
05/08/2008 Centralised - Variation EMEA/H/C/717/II/8 (2008)4279 of 31/07/2008
08/08/2008 Centralised - Variation EMEA/H/C/717/IA/13
Updated with Decision(2008)6418 of 27/10/2008
26/08/2008 Centralised - Variation EMEA/H/C/717/II/5 (2008)4655 of 22/08/2008
29/10/2008 Centralised - Variation EMEA/H/C/717/II/16 (2008)6418 of 27/10/2008
24/11/2008 Centralised - Variation EMEA/H/C/717/II/15 (2008)7423 of 20/11/2008
24/12/2008 Centralised - Variation EMEA/H/C/717/II/17 (2008)8968 of 22/12/2008
20/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IA/22
20/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IA/21
23/01/2009 Centralised - Variation EMEA/H/C/717/IB/20
Updated with Decision(2009)6383 of 07/08/2009
26/02/2009 Centralised - Variation EMEA/H/C/717/II/14 (2009)1353 of 24/02/2009
04/05/2009 Corrigendum (2009)1353 corr of 30/04/2009
29/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/II/23
11/08/2009 Centralised - Variation EMEA/H/C/717/II/25 (2009)6383 of 07/08/2009
21/10/2009 Centralised - Variation EMEA/H/C/717/II/24 (2009)8268 of 19/10/2009
17/12/2009 Centralised - Variation EMEA/H/C/717/II/26 (2009)10505 of 16/12/2009
18/12/2009 Centralised - Variation EMEA/H/C/717/II/26 (2009)10504 of 16/12/2009
04/01/2010 Centralised - Variation EMEA/H/C/717/IB/30
Updated with Decision(2010)1811 of 15/03/2010
11/01/2010 Centralised - Variation EMEA/H/C/717/II/29 (2010)64 of 08/01/2010
12/01/2010 Centralised - Variation EMEA/H/C/717/II/29 (2010)65 of 08/01/2010
14/01/2010 Centralised - Variation EMEA/H/C/717/II/28 (2010)117 of 12/01/2010
17/03/2010 Centralised - Variation (2010)1811 of 15/03/2010
23/03/2010 Centralised - Variation EMEA/H/C/717/IB/31
Updated with Decision(2010)7028 of 05/10/2010
25/03/2010 Centralised - Variation EMEA/H/C/717/II/27 (2010)2005 of 23/03/2010
10/07/2010 Centralised - Variation EMEA/H/C/717/IA/37/G
Updated with Decision(2010)7028 of 05/10/2010
23/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IB/35
07/10/2010 Centralised - Variation (2010)7028 of 05/10/2010
22/10/2010 Centralised - Variation EMEA/H/C/717/IA/43
Updated with Decision(2010)9517 of 17/12/2010
27/10/2010 Centralised - Variation EMEA/H/C/717/II/33 (2010)7534 of 25/10/2010
14/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IA/44
14/12/2010 Centralised - Variation EMEA/H/C/717/II/32 (2010)9284 of 13/12/2010
14/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IA/45
15/12/2010 Centralised - Variation EMEA/H/C/717/II/32 (2010)9285 of 13/12/2010
22/12/2010 Centralised - Variation EMEA/H/C/717/II/34, 41 (2010)9517 of 17/12/2010
26/01/2011 Centralised - Variation EMEA/H/C/717/II/42/G (2011)409 of 21/01/2011
01/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/717/IA/47
24/05/2011 Centralised - Variation EMEA/H/C/717/IA/49
Updated with Decision(2012)93 of 09/01/2012
15/07/2011 Centralised - Variation EMEA/H/C/717/IA/51/G
Updated with Decision(2012)93 of 09/01/2012
11/01/2012 Centralised - Variation (2012)93 of 09/01/2012
18/01/2012 Referral EMEA/H/C/717/A-20/48 (2012)199 of 13/01/2012
17/04/2012 Centralised - Renewal EMEA/H/C/717/R/54 (2012)2546 of 13/04/2012
12/09/2012 Centralised - Variation EMEA/H/C/717/X/46/G (2012)6400 of 10/09/2012
22/11/2012 Centralised - Variation EMEA/H/C/717/II/58 (2012)8585 of 19/11/2012
21/01/2013 Centralised - 2-Monthly update EMEA/H/C/717/II/60 (2013)319 of 17/01/2013
19/04/2013 Centralised - Variation EMEA/H/C/717/IB/61/G
Updated with Decision(2013)3812 of 13/06/2013
17/06/2013 Centralised - Variation EMEA/H/C/717/II/56 (2013)3812 of 13/06/2013
15/11/2013 Centralised - Modification EMEA/H/C/717/PSU/40 (2013)8084 of 13/11/2013
20/02/2014 Centralised - Variation EMEA/H/C/717/II/72
Updated with Decision(2014)7146 of 30/09/2014
02/10/2014 Centralised - Modification EMEA/H/C/717/II/70, EMEA/H/C/717/PSUV/74 (2014)7146 of 30/09/2014