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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Arzerra
|
| Auth. number : | EU/1/10/625 |
| INN : | Ofatumumab |
| Orphan status based on designation EU/3/08/581 added on 21/04/2010 | |
| ATC: | L - Antineoplastic and immunomodulating agents L01 - Cytostatics L01X - Other cytostatics L01XC - Monoclonal antibodies L01XC10 - Ofatumumab (See WHO ATC Index) |
| Indication: | Arzerra is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab. |
| Marketing Authorisation Holder: | Glaxo Group Limited
Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | EMEA/H/C/1131/II/1/G | ||||
| 09/11/2010 | Centralised - Variation | 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 | EMEA/H/C/1131/II/3/G | ||||
| 06/01/2011 | Centralised - Variation | 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 | 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 | ||||