Methylthioninium chloride Proveblue


methylthioninium chloride

This medicine is authorised for use in the European Union.


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 10/07/2023

Authorisation details

Product details
Methylthioninium chloride Proveblue
Agency product number
Active substance
methylthioninium chloride
International non-proprietary name (INN) or common name
methylthioninium chloride
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Provepharm SAS
Date of issue of marketing authorisation valid throughout the European Union
Contact address
22 Rue Marc Donadille
13013 Marseille

Product information

12/05/2023 Methylthioninium chloride Proveblue - EMEA/H/C/002108 - II/0056

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

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

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

How useful was this page?

Add your rating
4 ratings