Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Aloxi   
Auth. number : EU/1/04/306
INN : Palonosetron
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A04 - Antiemetics and antinauseants
Pharmacological subgroup: A04A - Antiemetics and antinauseants
Chemical subgroup: A04AA - Serotonin (5HT3) antagonists
Chemical substance: A04AA05 - Palonosetron
(See WHO ATC Index)
Indication: Aloxi is indicated in adults for:
• the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
• the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Marketing Authorisation Holder: Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland

  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
24/03/2005 Centralised - Authorisation EMEA/H/C/563 (2005)1018 of 22/03/2005
08/06/2005 Centralised - Variation EMEA/H/C/563/N/1
Updated with Decision(2009)668 of 29/01/2009
17/08/2005 Centralised - Variation EMEA/H/C/563/N/3
Updated with Decision(2009)668 of 29/01/2009
24/08/2005 Centralised - Variation EMEA/H/C/563/IB/2
03/02/2006 Centralised - Variation EMEA/H/C/563/II/4
10/04/2006 Centralised - Variation EMEA/H/C/563/N/5
Updated with Decision(2009)668 of 29/01/2009
13/04/2007 Centralised - Variation EMEA/H/C/563/N/6
Updated with Decision(2009)668 of 29/01/2009
16/11/2007 Centralised - Variation EMEA/H/C/563/IA/7
17/12/2007 Centralised - Variation EMEA/H/C/563/N/8
Updated with Decision(2009)668 of 29/01/2009
24/01/2008 Centralised - Variation EMEA/H/C/563/IB/10
24/01/2008 Centralised - Variation EMEA/H/C/563/IB/9
18/07/2008 Centralised - Variation EMEA/H/C/563/N/11
Updated with Decision(2009)668 of 29/01/2009
01/09/2008 Centralised - Variation EMEA/H/C/563/IA/14
02/02/2009 Centralised - Variation EMEA/H/C/563/II/12 (2009)668 of 29/01/2009
30/04/2009 Centralised - Variation EMEA/H/C/563/N/16
Updated with Decision(2009)10591 of 18/12/2009
29/05/2009 Centralised - Variation EMEA/H/C/563/IB/17
Updated with Decision(2009)10591 of 18/12/2009
24/09/2009 Centralised - Variation EMEA/H/C/563/IB/21
26/11/2009 Centralised - Variation EMEA/H/C/563/II/19
22/12/2009 Centralised - Variation (2009)10591 of 18/12/2009
11/03/2010 Centralised - Variation EMEA/H/C/563/IB/22
25/03/2010 Centralised - Renewal EMEA/H/C/563/R/20 (2010)2036 of 23/03/2010
07/05/2010 Centralised - Variation EMEA/H/C/563/X/15 (2010)3073 of 05/05/2010
26/07/2010 Centralised - Variation EMEA/H/C/563/N/23
Updated with Decision(2010)9638 of 20/12/2010
28/10/2010 Centralised - Variation EMEA/H/C/563/IB/24
04/01/2011 Centralised - Variation EMEA/H/C/563/II/25 (2010)9638 of 20/12/2010
23/02/2012 Centralised - Variation EMEA/H/C/563/II/27 (2012)1261 of 21/02/2012
27/05/2013 Centralised - Modification EMEA/H/C/563/PSU/20 (2013)3103 of 22/05/2013
13/12/2013 Centralised - Variation EMEA/H/C/563/N/34
Updated with Decision(2014)2822 of 23/04/2014
25/04/2014 Centralised - Modification EMEA/H/C/563/PSUV/33 (2014)2822 of 23/04/2014