Methylthioninium chloride Proveblue
methylthioninium chloride
Table of contents
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.
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 |
25
|
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
18/11/2022 Methylthioninium chloride Proveblue - EMEA/H/C/002108 - II/0052/G
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:
- 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
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).