Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cyanokit   
Auth. number : EU/1/07/420
Active substance : 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.

Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Marketing Authorisation Holder: SERB S.A.
Avenue Louise 480, 1050 Brussels, Belgique
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 (no change in Commission Decision) EMEA/H/C/806/IB/2
16/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/806/IA/3
16/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/806/IA/5
16/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/806/IA/4
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 (no change in Commission Decision) 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 - Notification EMEA/H/C/806/N/21
Updated with Decision(2015)4370 of 22/06/2015
14/11/2014 Centralised - Variation EMEA/H/C/806/IB/22
Updated with Decision(2015)4370 of 22/06/2015
24/06/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/806/T/24 (2015)4370 of 22/06/2015
14/08/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/806/T/24 (2015)5847 of 12/08/2015