Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Samsca   
Auth. number : EU/1/09/539
INN : tolvaptan
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C03 - Diuretics
Pharmacological subgroup: C03X - Other diuretics
Chemical subgroup: C03XA - Vasopressin antagonists
Chemical substance: C03XA01 - Tolvaptan
(See WHO ATC Index)
Indication: Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Marketing Authorisation Holder: Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, 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
05/08/2009 Centralised - Authorisation EMEA/H/C/980 (2009)6250 of 03/08/2009
01/10/2010 Centralised - Variation EMEA/H/C/980/N/1
Updated with Decision(2011)4399 of 16/06/2011
24/03/2011 Centralised - Variation EMEA/H/C/980/IA/20/G
Updated with Decision(2011)4399 of 16/06/2011
21/06/2011 Centralised - Variation (2011)4399 of 16/06/2011
16/08/2011 Centralised - Variation EMEA/H/C/980/IB/3
Updated with Decision(2012)1737 of 09/03/2012
13/03/2012 Centralised - Variation (2012)1737 of 09/03/2012
24/04/2012 Centralised - Variation EMEA/H/C/980/II/5, 6, 7 (2012)2834 of 20/04/2012
23/10/2012 Centralised - Variation EMEA/H/C/980/IAin/9/G
Updated with Decision(2012)7882 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7882 of 29/10/2012
25/02/2013 Centralised - Variation EMEA/H/C/980/II/12
Updated with Decision(2013)3238 of 27/05/2013
29/05/2013 Centralised - Variation EMEA/H/C/980/II/13 (2013)3238 of 27/05/2013
21/11/2013 Centralised - Variation EMEA/H/C/980/IAIN/15
Updated with Decision(2014)1480 of 28/02/2014
04/03/2014 Centralised - Variation EMEA/H/C/980/II/17 (2014)1480 of 28/02/2014
23/06/2014 Centralised - Renewal EMEA/H/C/980/R/16 (2014)4276 of 19/06/2014