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

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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