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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Rapiscan
|
| Auth. number : | EU/1/10/643 |
| INN : | regadenoson |
| ATC: | C - Cardiovascular system C01 - Cardiac therapy C01E - Other cardiac preparations C01EB - Other cardiac preparations 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
|
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 |
| 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 |