Cyanokit

RSS

hydroxocobalamin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Cyanokit. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cyanokit.

This EPAR was last updated on 18/01/2019

Authorisation details

Product details
Name
Cyanokit
Agency product number
EMEA/H/C/000806
Active substance
hydroxocobalamin
International non-proprietary name (INN) or common name
hydroxocobalamin
Therapeutic area (MeSH)
Poisoning
Anatomical therapeutic chemical (ATC) code
V03AB33
Publication details
Marketing-authorisation holder
SERB SA
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
23/11/2007
Contact address

Avenue Louise 480
1050 Brussels
Belgium

Product information

27/11/2018 Cyanokit - EMEA/H/C/000806 - IAIN/0033/G

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Treatment of known or suspected cyanide poisoning.

Cyanokit is to be administered together with appropriate decontamination and supportive measures.

Assessment history

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