Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Stelara   
Auth. number : EU/1/08/494
INN : ustekinumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC05 - Ustekinumab
(See WHO ATC Index)
Indication: Plaque psoriasis
STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).
Psoriatic arthritis (PsA)
STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  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
20/01/2009 Centralised - Authorisation EMEA/H/C/958 (2009)236 of 16/01/2009
20/01/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/958 (2009)237 of 16/01/2009
01/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/958/IA/3
24/12/2009 Centralised - Variation EMEA/H/C/958/II/1 (2009)10749 of 22/12/2009
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/958/II/4
24/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/958/II/5
12/03/2010 Centralised - Variation EMEA/H/C/958/X/2 (2010)1651 of 11/03/2010
15/03/2010 Centralised - Variation EMEA/H/C/958/X/2 (2010)1650 of 11/03/2010
17/03/2010 Centralised - Variation EMEA/H/C/958/II/6 (2010)1837 of 15/03/2010
04/05/2010 Corrigendum (2009)10749 corr of 27/04/2010
08/06/2010 Centralised - Variation EMEA/H/C/958/IG/7
Updated with Decision(2010)5994 of 26/08/2010
29/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/958/IA/9
25/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/958/IB/10
30/08/2010 Centralised - Variation EMEA/H/C/958/II/7/G (2010)5994 of 26/08/2010
23/12/2010 Centralised - Variation EMEA/H/C/958/II/8/G (2010)9620 of 20/12/2010
06/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/958/IA/11
28/02/2011 Centralised - Variation EMEA/H/C/958/IA/12/G
Updated with Decision(2011)5528 of 26/07/2011
28/07/2011 Centralised - Variation EMEA/H/C/958/II/15/G (2011)5528 of 26/07/2011
29/07/2011 Centralised - Variation EMEA/H/C/958/IA/16/G
Updated with Decision(2011)7388 of 12/10/2011
14/10/2011 Centralised - Variation (2011)7388 of 12/10/2011
17/01/2012 Centralised - Variation EMEA/H/C/958/II/18 (2012)189 of 13/01/2012
24/02/2012 Centralised - Variation EMEA/H/C/958/II/21 (2012)1282 of 21/02/2012
05/06/2012 Centralised - Variation EMEA/H/C/958/IB/25
Updated with Decision(2012)7916 of 29/10/2012
05/11/2012 Centralised - Variation (2012)7916 of 29/10/2012
17/01/2013 Centralised - Variation EMEA/H/C/958/II/28
Updated with Decision(2013)6220 of 19/09/2013
22/02/2013 Centralised - Variation EMEA/H/C/958/IB/31
Updated with Decision(2013)6220 of 19/09/2013
25/07/2013 Centralised - Variation EMEA/H/C/958/II/29
Updated with Decision(2013)6220 of 19/09/2013
25/07/2013 Centralised - Variation EMEA/H/C/958/II/33
Updated with Decision(2013)6220 of 19/09/2013
23/09/2013 Centralised - Renewal EMEA/H/C/958/R/34 (2013)6220 of 19/09/2013
12/12/2013 Centralised - Notification EMEA/H/C/958/N/38
Updated with Decision(2014)1304 of 21/02/2014
25/02/2014 Centralised - 2-Monthly update (2014)1304 of 21/02/2014
20/03/2014 Centralised - Variation EMEA/H/C/958/II/36
Updated with Decision(2014)9035 of 21/11/2014
30/10/2014 Centralised - Variation EMEA/H/C/958/IA/43/G
25/11/2014 Centralised - 2-Monthly update EMEA/H/C/958/II/41 (2014)9035 of 21/11/2014