Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: SANCUSO   
Auth. number : EU/1/12/766
INN : granisetron
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A04 - Antiemetics and antinauseants
Pharmacological subgroup: A04A - Antiemetics and antinauseants
Chemical subgroup: A04AA - Serotonin (5HT3) antagonists
Chemical substance: A04AA02 - Granisetron
(See WHO ATC Index)
Indication: SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult.
Marketing Authorisation Holder: ProStrakan Limited
Galabank Business Park, Galashiels TD1 1QH, 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
25/04/2012 Centralised - Authorisation EMEA/H/C/2296 (2012)2814 of 20/04/2012
02/08/2013 Centralised - Variation EMEA/H/C/2296/N/28
Updated with Decision(2014)5259 of 18/07/2014
28/11/2013 Centralised - Variation EMEA/H/C/2296/IA/29
Updated with Decision(2014)5259 of 18/07/2014
23/07/2014 Centralised - Modification EMEA/H/C/2296/PSUV/30 (2014)5259 of 18/07/2014