Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Teslascan
Auth. number : EU/1/97/040
Active substance : Mangafodipir
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V08 - Contrast media
Pharmacological subgroup: V08C - Magnetic resonance imaging contrast media
Chemical subgroup: V08CA - Paramagnetic contrast media
Chemical substance: V08CA05 - Mangafodipir
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
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
23/05/1997 Centralised - Authorisation EMEA/H/C/137 (97)1423 of 22/05/1997
28/04/1999 Centralised - Notification EMEA/H/C/137/N/2 (1999)1010 of 19/04/1999
29/03/2001 Centralised - Variation EMEA/H/C/137/II/6 (2001)788 of 26/03/2001
05/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/137/I/8
25/02/2002 Centralised - Variation EMEA/H/C/137/I/9 (2002)634 of 19/02/2002
13/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/137/II/7
20/06/2002 Centralised - Renewal EMEA/H/C/137/R/10 (2002)2322 of 17/06/2002
19/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/137/IA/13
19/09/2006 Centralised - Variation EMEA/H/C/137/IA/12
Updated with Decision(2007)1800 of 17/04/2007
22/09/2006 Centralised - Notification EMEA/H/C/137/N/14
Updated with Decision(2007)1800 of 17/04/2007
19/04/2007 Centralised - Variation (2007)1800 of 17/04/2007
25/05/2007 Centralised - Renewal EMEA/H/C/137/R/15 (2007)2260 of 22/05/2007
27/10/2009 Centralised - Variation EMEA/H/C/137/II/16 (2009)8396 of 23/10/2009
25/06/2012 Centralised - Withdrawal (2012)4355 of 21/06/2012