Methylthioninium chloride Proveblue

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methylthioninium chloride

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

Overview

This is a summary of the European public assessment report (EPAR) for Methylthioninium chloride Proveblue. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and itsconditions of use. It is not intended to provide practical advice on how to use Methylthioninium chloride Proveblue

For practical information about using Methylthioninium chloride Proveblue, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 07/05/2018

Authorisation details

Product details
Name
Methylthioninium chloride Proveblue
Agency product number
EMEA/H/C/002108
Active substance
methylthioninium chloride
International non-proprietary name (INN) or common name
methylthioninium chloride
Therapeutic area (MeSH)
Methemoglobinemia
Anatomical therapeutic chemical (ATC) code
V03AB17
Publication details
Marketing-authorisation holder
Provepharm SAS
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
06/05/2011
Contact address
ProveCube
22 Rue Marc Donadille
13013 Marseille
France

Product information

06/04/2018 Methylthioninium chloride Proveblue - EMEA/H/C/002108 - N/0042

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

Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia.

Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).

Assessment history

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