Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Arzerra   
Auth. number : EU/1/10/625
Active substance : Ofatumumab
Orphan market exclusivity for "Treatment of chronic lymphocytic leukaemia" (based on designation EU/3/08/581) started on 21/04/2010
   10 years of market exclusivity
   This orphan market exclusivity will expire on 21/04/2020
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC10 - Ofatumumab
(See WHO ATC Index)
Indication: Previously untreated chronic lymphocytic leukaemia (CLL):
Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.

Relapsed CLL:
Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.

Refractory CLL:
Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.
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
21/04/2010 Centralised - Authorisation EMEA/H/C/1131 (2010)2578 of 19/04/2010
05/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1131/II/1/G
09/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1131/II/2
22/12/2010 Centralised - Variation EMEA/H/C/1131/IA/7
Updated with Decision(2011)1207 of 21/02/2011
03/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1131/II/3/G
06/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1131/IA/6/G
26/01/2011 Centralised - Annual renewal EMEA/H/C/1131/R/5 (2011)411 of 21/01/2011
25/02/2011 Centralised - Variation EMEA/H/C/1131/II/4/G (2011)1207 of 21/02/2011
07/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1131/II/3/G
28/12/2011 Centralised - Variation EMEA/H/C/1131/II/9, 10 (2011)10111 of 22/12/2011
13/02/2012 Centralised - Annual renewal EMEA/H/C/1131/R/11 (2012)901 of 09/02/2012
24/07/2012 Centralised - Variation EMEA/H/C/1131/II/12 (2012)5283 of 20/07/2012
22/02/2013 Centralised - Annual renewal EMEA/H/C/1131/R/15 (2013)1092 of 20/02/2013
26/03/2013 Centralised - Variation EMEA/H/C/1131/IB/16/G
Updated with Decision(2014)326 of 16/01/2014
18/04/2013 Centralised - Variation EMEA/H/C/1131/IG/279
Updated with Decision(2014)326 of 16/01/2014
21/01/2014 Centralised - Annual renewal EMEA/H/C/1131/II/21, EMEA/H/C/1131/R/18 (2014)326 of 16/01/2014
13/06/2014 Centralised - Variation EMEA/H/C/1131/IAin/28
Updated with Decision(2014)5501 of 28/07/2014
02/07/2014 Centralised - 2-Monthly update EMEA/H/C/1131/II/23 (2014)4591 of 30/06/2014
30/07/2014 Centralised - 2-Monthly update EMEA/H/C/1131/II/27 (2014)5501 of 28/07/2014
30/10/2014 Centralised - Variation EMEA/H/C/1131/IB/32
Updated with Decision(2015)1031 of 17/02/2015
19/02/2015 Centralised - Annual renewal EMEA/H/C/1131/R/33 (2015)1031 of 17/02/2015
28/04/2015 Centralised - Authorisation - Switch to non-conditional EMEA/H/C/1131/II/35 (2015)2898 of 24/04/2015
08/05/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1131/T/38 (2015)3219 of 06/05/2015
13/07/2015 Centralised - Variation EMEA/H/C/1131/IAIN/39/G
Updated with Decision(2016) 4403 of 06/07/2016
18/02/2016 Centralised - Variation EMEA/H/C/1131/II/43
Updated with Decision(2016) 4403 of 06/07/2016
08/07/2016 Centralised - Yearly update (2016) 4403 of 06/07/2016
12/12/2016 Centralised - 2-Monthly update EMEA/H/C/1131/II/45 (2016) 8522 of 08/12/2016