Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rapiscan   
Auth. number : EU/1/10/643
INN : regadenoson
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C01 - Cardiac therapy
Pharmacological subgroup: C01E - Other cardiac preparations
Chemical subgroup: C01EB - Other cardiac preparations
Chemical substance: C01EB21 - Regadenoson
(See WHO ATC Index)
Indication: Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.Rapiscan is for diagnostic use only.
Marketing Authorisation Holder: Rapidscan Pharma Solutions EU Ltd
Regent's Place, 338 Euston Road, London NW1 3BT, 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
08/09/2010 Centralised - Authorisation EMEA/H/C/1176 (2010)6234 of 06/09/2010
13/01/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1176/T/1 (2011)137 of 11/01/2011
28/04/2011 Centralised - Variation EMEA/H/C/1176/IA/3/G
Updated with Decision(2011)7946 of 27/10/2011
15/07/2011 Centralised - Variation EMEA/H/C/1176/IB/4
Updated with Decision(2011)7946 of 27/10/2011
04/11/2011 Centralised - Variation EMEA/H/C/1176/II/2 (2011)7946 of 27/10/2011
23/03/2012 Centralised - Variation EMEA/H/C/1176/II/5 (2012)2025 of 21/03/2012
27/09/2012 Centralised - Variation EMEA/H/C/1176/IAin/8
Updated with Decision(2012)7933 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7933 of 29/10/2012
15/11/2012 Centralised - Variation EMEA/H/C/1176/II/6
Updated with Decision(2013)8161 of 15/11/2013
19/11/2013 Centralised - Yearly update (2013)8161 of 15/11/2013
21/01/2014 Centralised - Modification EMEA/H/C/1176/PSU/11 (2014)306 of 16/01/2014
24/07/2014 Centralised - Modification EMEA/H/C/1176/PSUV/14 (2014)5319 of 22/07/2014