Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cyanokit   
Auth. number : EU/1/07/420
INN : hydroxocobalamin
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: V03AB33 - Hydroxocobalamin
(See WHO ATC Index)
Indication: Treatment of known or suspected cyanide poisoning.
Marketing Authorisation Holder: Merck Santé s.a.s.
37 rue Saint-Romain, F-69379 Lyon CEDEX 08, France

  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
27/11/2007 Centralised - Authorisation EMEA/H/C/806 (2007)5849 of 23/11/2007
21/01/2009 Centralised - Variation EMEA/H/C/806/II/1 (2009)231 of 16/01/2009
03/02/2009 Centralised - Variation EMEA/H/C/806/IB/2
16/11/2009 Centralised - Variation EMEA/H/C/806/IA/4
16/11/2009 Centralised - Variation EMEA/H/C/806/IA/3
16/11/2009 Centralised - Variation EMEA/H/C/806/IA/5
28/05/2010 Centralised - Variation EMEA/H/C/806/II/6 (2010)3498 of 26/05/2010
11/10/2010 Centralised - Variation EMEA/H/C/806/X/7 (2010)7082 of 07/10/2010
06/01/2011 Centralised - Variation EMEA/H/C/806/IA/8
20/04/2011 Centralised - Variation EMEA/H/C/806/IB/9
Updated with Decision(2011)8248 of 10/11/2011
15/11/2011 Centralised - Variation (2011)8248 of 10/11/2011
25/07/2012 Centralised - Renewal EMEA/H/C/806/R/12 (2012)5306 of 20/07/2012
07/08/2014 Centralised - Variation EMEA/H/C/806/N/21