Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Luminity   
Auth. number : EU/1/06/361
INN : perflutren
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V08 - Contrast media
Pharmacological subgroup: V08D - Ultrasound contrast media
Chemical subgroup: V08DA - Ultrasound contrast media
Chemical substance: V08DA04 - Microspheres of phospholipids
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Marketing Authorisation Holder: Lantheus MI UK Limited
Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, 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
22/09/2006 Centralised - Authorisation EMEA/H/C/654 (2006)4282 of 20/09/2006
29/01/2007 Centralised - Variation EMEA/H/C/654/IA/1
Updated with Decision(2007)4028 of 22/08/2007
13/04/2007 Centralised - Notification EMEA/H/C/654/N/2
Updated with Decision(2007)4028 of 22/08/2007
24/08/2007 Centralised - Variation (2007)4028 of 22/08/2007
25/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/654/IB/4
31/10/2007 Centralised - Variation EMEA/H/C/654/II/3 (2007)5368 of 29/10/2007
19/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/654/IB/5
14/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/654/IB/6
27/11/2008 Centralised - Variation EMEA/H/C/654/II/8 (2008)7605 of 25/11/2008
24/02/2009 Centralised - Variation EMEA/H/C/654/II/9 (2009)1277 of 20/02/2009
30/07/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/654/T/10 (2009)6109 of 27/07/2009
25/08/2009 Centralised - Variation EMEA/H/C/654/II/7 (2009)6625 of 21/08/2009
25/07/2011 Centralised - Variation EMEA/H/C/654/IA/12/G
Updated with Decision(2011)6520 of 13/09/2011
15/09/2011 Centralised - Renewal EMEA/H/C/654/R/11 (2011)6520 of 13/09/2011
12/12/2011 Referral EMEA/H/C/654/A-20/13 (2011)9291 of 07/12/2011
31/05/2012 Referral EMEA/H/C/654/A-20/13 (2012)3582 of 25/05/2012
25/02/2014 Centralised - Lift of suspension EMEA/H/C/654/II/17/G (2014)1312 of 21/02/2014
22/05/2014 Centralised - Variation EMEA/H/C/654/II/18