Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ivemend   
Auth. number : EU/1/07/437
INN : fosaprepitant
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A04 - Antiemetics and antinauseants
Pharmacological subgroup: A04A - Antiemetics and antinauseants
Chemical subgroup: A04AD - Other antiemetics
Chemical substance: A04AD12 - Aprepitant
(See WHO ATC Index)
Indication: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults.
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.
IVEMEND 150 mg is given as part of a combination therapy.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
16/01/2008 Centralised - Authorisation EMEA/H/C/743 (2008)155 of 11/01/2008
15/05/2008 Centralised - Variation EMEA/H/C/743/IA/1
Updated with Decision(2009)1019 of 10/02/2009
20/05/2008 Centralised - Notification EMEA/H/C/743/N/2
Updated with Decision(2009)1019 of 10/02/2009
12/02/2009 Centralised - Variation (2009)1019 of 10/02/2009
31/07/2009 Centralised - Variation EMEA/H/C/743/II/3, 4 (2009)6194 of 29/07/2009
04/01/2010 Centralised - Variation EMEA/H/C/743/II/5 (2009)10779 of 23/12/2009
30/03/2010 Centralised - Variation EMEA/H/C/743/II/7 (2010)2164 of 26/03/2010
06/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/743/IA/8/G
02/09/2010 Centralised - Variation EMEA/H/C/743/X/6 (2010)6091 of 31/08/2010
26/10/2010 Centralised - Variation EMEA/H/C/743/IA/10
Updated with Decision(2011)1197 of 21/02/2011
26/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/743/IA/11/G
18/11/2010 Centralised - Variation EMEA/H/C/743/IG/27/G
Updated with Decision(2011)1197 of 21/02/2011
24/02/2011 Centralised - Variation (2011)1197 of 21/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/743/II/9 (2011)1930 of 18/03/2011
16/06/2011 Centralised - Variation EMEA/H/C/743/II/12 (2011)4293 of 14/06/2011
25/07/2011 Centralised - Notification EMEA/H/C/743/N/14
Updated with Decision(2011)10112 of 22/12/2011
03/01/2012 Centralised - Variation EMEA/H/C/743/WS/180 (2011)10112 of 22/12/2011
14/11/2012 Centralised - Renewal EMEA/H/C/743/R/18 (2012)8377 of 12/11/2012
26/03/2013 Centralised - 2-Monthly update EMEA/H/C/743/WS/354 (2013)1847 of 22/03/2013
02/07/2013 Centralised - Notification EMEA/H/C/743/N/21
Updated with Decision(2013)9836 of 20/12/2013
02/01/2014 Centralised - Modification EMEA/H/C/743/PSUV/22 (2013)9836 of 20/12/2013
12/09/2014 Centralised - Notification EMEA/H/C/743/N/26