Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Emend   
Auth. number : EU/1/03/262
INN : aprepitant
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.
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
13/11/2003 Centralised - Authorisation EMEA/H/C/527 (2003)4287 of 11/11/2003
16/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/527/IB/2
16/04/2004 Centralised - Variation EMEA/H/C/527/IB/1
Updated with Decision(2004)4249 of 22/10/2004
15/06/2004 Centralised - Notification EMEA/H/C/527/N/3
Updated with Decision(2004)4249 of 22/10/2004
18/07/2004 Centralised - Notification EMEA/H/C/527/N/4
Updated with Decision(2004)4249 of 22/10/2004
13/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/527/IB/7
26/10/2004 Centralised - Variation EMEA/H/C/527/II/5 (2004)4249 of 22/10/2004
27/10/2004 Centralised - Variation EMEA/H/C/527/IB/8
Updated with Decision(2005)1093 of 30/03/2005
01/04/2005 Centralised - Variation EMEA/H/C/527/II/6 (2005)1093 of 30/03/2005
03/05/2005 Centralised - Variation EMEA/H/C/527/II/10 (2005)1416 of 28/04/2005
03/05/2005 Centralised - Variation EMEA/H/C/527/II/9 (2005)1415 of 28/04/2005
23/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/527/II/12
30/09/2005 Centralised - Notification EMEA/H/C/527/N/13
Updated with Decision(2005)4392 of 07/11/2005
09/11/2005 Centralised - Variation EMEA/H/C/527/II/11 (2005)4392 of 07/11/2005
31/05/2006 Centralised - Variation EMEA/H/C/527/II/14 (2006)2191 of 29/05/2006
31/05/2006 Centralised - Variation EMEA/H/C/527/X/15 (2006)2192 of 29/05/2006
01/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/527/IA/16
02/03/2007 Centralised - Variation EMEA/H/C/527/II/17 (2007)739 of 28/02/2007
24/09/2008 Centralised - Renewal EMEA/H/C/527/R/20 (2008)5457 of 22/09/2008
11/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/527/IA/21
04/08/2009 Centralised - Variation EMEA/H/C/527/II/22, 23 (2009)6243 of 31/07/2009
14/01/2010 Centralised - Variation EMEA/H/C/527/II/24 (2010)122 of 12/01/2010
09/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/527/IA/8/G
25/08/2010 Centralised - Notification EMEA/H/C/527/N/25
Updated with Decision(2011)696 of 01/02/2011
18/11/2010 Centralised - Variation EMEA/H/C/527/IG/27/G
Updated with Decision(2011)696 of 01/02/2011
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/527/IA/27
03/02/2011 Centralised - Variation (2011)696 of 01/02/2011
12/07/2011 Centralised - Notification EMEA/H/C/527/N/30
Updated with Decision(2011)7802 of 24/10/2011
27/10/2011 Centralised - Variation EMEA/H/C/527/II/29 (2011)7802 of 24/10/2011
30/11/2011 Centralised - Variation EMEA/H/C/527/X/28 (2011)8961 of 28/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/527/WS/180 (2011)9954 of 19/12/2011
23/02/2012 Centralised - Variation EMEA/H/C/527/IB/35
Updated with Decision(2012)7217 of 10/10/2012
15/10/2012 Centralised - Variation (2012)7217 of 10/10/2012
13/12/2012 Centralised - Variation EMEA/H/C/527/IB/38
Updated with Decision(2013)1851 of 22/03/2013
26/03/2013 Centralised - 2-Monthly update EMEA/H/C/527/WS/354/39 (2013)1851 of 22/03/2013
02/07/2013 Centralised - Notification EMEA/H/C/527/N/41
Updated with Decision(2013)9729 of 18/12/2013
20/12/2013 Centralised - Modification EMEA/H/C/527/PSUV/42 (2013)9729 of 18/12/2013