Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: DaTSCAN   
Auth. number : EU/1/00/135
INN : Ioflupane (123I)
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09A - Central nervous system
Chemical subgroup: V09AB - Iodine (123I) compounds
Chemical substance: V09AB03 - Iodine ioflupane (123I)
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:
- In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinsonӳ Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
- In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimerӳ disease.
DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinsonӳ disease dementia.
Marketing Authorisation Holder: GE Healthcare Limited
Little Chalfont, Buckinhamshire HP7 9NA, 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
02/08/2000 Centralised - Authorisation EMEA/H/C/266 (2000)2331 of 27/07/2000
23/02/2001 Centralised - Variation EMEA/H/C/266/II/1 (2001)260 of 22/02/2001
02/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/I/2
09/05/2002 Centralised - Variation EMEA/H/C/266/I/4 (2002)1878 of 07/05/2002
11/09/2002 Centralised - Variation EMEA/H/C/266/II/3 (2002)3375 of 09/09/2002
21/10/2002 Centralised - Notification EMEA/H/C/266/N/7 (2002)4060 of 17/10/2002
30/10/2002 Centralised - Variation EMEA/H/C/266/II/5 (2002)4336 of 28/10/2002
29/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/II/6
22/01/2004 Centralised - Notification EMEA/H/C/266/N/8 (2004)135 of 20/01/2004
01/06/2004 Centralised - Notification EMEA/H/C/266/N/9
Updated with Decision(2005)526 of 28/02/2005
02/03/2005 Centralised - Variation EMEA/H/C/266/II/10 (2005)526 of 28/02/2005
16/06/2005 Centralised - Variation EMEA/H/C/266/IA/12
Updated with Decision(2005)3474 of 07/09/2005
09/09/2005 Centralised - Renewal EMEA/H/C/266/R/11 (2005)3474 of 07/09/2005
12/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/IB/13
30/09/2005 Centralised - Notification EMEA/H/C/266/N/14
Updated with Decision(2006)2443 of 16/06/2006
08/11/2005 Centralised - Variation EMEA/H/C/266/IB/15
Updated with Decision(2006)2443 of 16/06/2006
21/11/2005 Centralised - Notification EMEA/H/C/266/N/16
Updated with Decision(2006)2443 of 16/06/2006
14/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/IB/17
06/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/II/19
20/06/2006 Centralised - Variation (2006)2443 of 16/06/2006
03/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/II/20
02/08/2006 Centralised - Variation EMEA/H/C/266/II/20 (2006)3539 of 28/07/2006
08/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/IA/22
15/08/2006 Centralised - Variation EMEA/H/C/266/IA/21
Updated with Decision(2007)1534 of 29/03/2007
20/09/2006 Corrigendum EMEA/H/C/266 (2006)4255 of 18/09/2006
31/10/2006 Centralised - Notification EMEA/H/C/266/N/23
Updated with Decision(2007)1534 of 29/03/2007
31/10/2006 Centralised - Notification EMEA/H/C/266/N/24
05/01/2007 Centralised - Notification EMEA/H/C/266/N/25
Updated with Decision(2007)1534 of 29/03/2007
02/04/2007 Centralised - Variation (2007)1534 of 29/03/2007
26/04/2007 Centralised - Variation EMEA/H/C/266/II/26 (2007)1895 of 24/04/2007
20/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/IB/30
20/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/IB/29
14/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/IB/31
14/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/IB/32
02/08/2010 Centralised - Renewal EMEA/H/C/266/R/33 (2010)5381 of 28/07/2010
10/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/266/II/34/G
21/04/2011 Centralised - Variation EMEA/H/C/266/II/35, 36, 37 (2011)2854 of 18/04/2011
26/03/2013 Centralised - 2-Monthly update EMEA/H/C/266/II/40 (2013)1850 of 22/03/2013
03/07/2013 Centralised - Notification EMEA/H/C/266/N/43