Cyanokit
hydroxocobalamin
Table of contents
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.
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 |
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
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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.