Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Optison   
Auth. number : EU/1/98/065
Active substance : 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: V08DA01 - Microspheres of human albumin
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or
established cardiovascular disease to provide opacification of cardiac chambers, enhance left
ventricular endocardial border delineation with resulting improvement in wall motion visualisation.
OPTISON should only be used in patients where the study without contrast enhancement is
inconclusive.
Marketing Authorisation Holder: GE Healthcare AS
Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norge
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
19/05/1998 Centralised - Authorisation EMEA/H/C/166 (1998)1354 of 18/05/1998
26/11/1998 Centralised - Notification EMEA/H/C/166/N/1 (1998)3580 of 19/11/1998
18/12/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/I/4
18/12/1998 Centralised - Variation EMEA/H/C/166/I/3
09/07/1999 Centralised - Notification EMEA/H/C/166/N/5 (1999)1899 of 29/06/1999
12/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/I/9
12/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/I/10
29/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/I/12
05/06/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/I/13
14/08/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/I/14
26/10/2000 Centralised - Notification EMEA/H/C/166/N/8 (2000)2849 of 23/10/2000
30/11/2000 Centralised - Variation EMEA/H/C/166/II/11 (2000)3397 of 29/11/2000
03/08/2001 Centralised - Variation EMEA/H/C/166/I/16 (2001)2069 of 01/08/2001
10/10/2001 Centralised - Notification EMEA/H/C/166/N/17 (2001)2786 of 08/10/2001
07/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/I/15
22/04/2002 Centralised - Notification EMEA/H/C/166/N/17 (2002)1554 of 18/04/2002
02/05/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/166/T/19 (2002)1822 of 29/04/2002
21/11/2002 Centralised - Variation EMEA/H/C/166/II/20 (2002)4586 of 20/11/2002
19/03/2003 Centralised - Variation EMEA/H/C/166/I/21 (2003)877 of 17/03/2003
19/05/2003 Centralised - Renewal EMEA/H/C/166/R/22 (2003)1680 of 15/05/2003
29/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/II/23
16/08/2004 Centralised - Variation EMEA/H/C/166/II/24 (2004)3201 of 12/08/2004
15/02/2005 Centralised - Notification EMEA/H/C/166/N/25
Updated with Decision(2006)3670 of 07/08/2006
10/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/IB/26
09/08/2006 Referral EMEA/H/C/166/A-20/166 (2006)3670 of 07/08/2006
09/10/2006 Centralised - Variation EMEA/H/C/166/IA/28
Updated with Decision(2007)3638 of 20/07/2007
09/10/2006 Centralised - Notification EMEA/H/C/166/N/29
Updated with Decision(2007)3638 of 20/07/2007
26/07/2007 Centralised - Variation (2007)3638 of 20/07/2007
16/06/2008 Centralised - Renewal EMEA/H/C/166/R/31 (2008)2882 of 12/06/2008
12/10/2009 Centralised - Lift of suspension EMEA/H/C/166/Z/32 (2009)7884 of 08/10/2009
01/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/IA/34
10/11/2010 Centralised - Variation EMEA/H/C/166/IB/35
Updated with Decision(2010)9606 of 20/12/2010
10/11/2010 Centralised - Variation EMEA/H/C/166/IB/36
Updated with Decision(2010)9606 of 20/12/2010
08/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/166/IA/38
22/12/2010 Centralised - Variation EMEA/H/C/166/II/37 (2010)9606 of 20/12/2010
24/07/2013 Centralised - Variation EMEA/H/C/166/IB/44
Updated with Decision(2014)4848 of 04/07/2014
08/05/2014 Centralised - Variation EMEA/H/C/166/IB/49
Updated with Decision(2014)4848 of 04/07/2014
08/07/2014 Centralised - Yearly update (2014)4848 of 04/07/2014