Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Bridion   
Auth. number : EU/1/08/466
INN : sugammadex
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AB - Antidotes
Chemical substance: V03AB35 - Sugammadex
(See WHO ATC Index)
Indication: Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
29/07/2008 Centralised - Authorisation EMEA/H/C/885 (2008)4105 of 25/07/2008
22/12/2009 Centralised - Variation EMEA/H/C/885/IA/6
22/12/2009 Centralised - Variation EMEA/H/C/885/IA/5
03/02/2010 Centralised - Variation EMEA/H/C/885/IB/4
11/02/2010 Centralised - Variation EMEA/H/C/885/II/2 (2010)924 of 09/02/2010
29/04/2010 Centralised - Variation EMEA/H/C/885/II/3 (2010)2848 of 27/04/2010
04/06/2010 Centralised - Variation EMEA/H/C/885/II/1 (2010)3649 of 02/06/2010
09/11/2010 Centralised - Variation EMEA/H/C/885/II/7 (2010)7737 of 03/11/2010
29/02/2012 Centralised - Variation EMEA/H/C/885/II/8/G (2012)1376 of 27/02/2012
25/07/2012 Centralised - Variation EMEA/H/C/885/II/10 (2012)5344 of 23/07/2012
29/10/2012 Centralised - Variation EMEA/H/C/885/II/11 (2012)7725 of 25/10/2012
30/05/2013 Centralised - Variation EMEA/H/C/885/II/15
Updated with Decision(2013)6805 of 09/10/2013
25/06/2013 Centralised - Renewal EMEA/H/C/885/R/13 (2013)4022 of 21/06/2013
27/07/2013 Centralised - Variation EMEA/H/C/885/IB/16
Updated with Decision(2013)6805 of 09/10/2013
18/10/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/885/T/17 (2013)6805 of 09/10/2013
20/02/2014 Centralised - Variation EMEA/H/C/885/II/19