Is Methylthioninium registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Methylthioninium, including Proveblue (5 mg/ml, Solution for injection, SAR 374.05).

Is Methylthioninium authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Methylthioninium: Methylthioninium chloride Proveblue, Lumeblue (previously Methylthioninium chloride Cosmo).

Is Methylthioninium on the WHO Model List of Essential Medicines?

Yes — 4.2. Antidotes and other substances used in poisonings > Specific (core list): Acquired methaemoglobinaemia.

Are there safety signals or safety updates for Methylthioninium?

MHRA: 1 entry (latest 2014-12-11).

Active substance

Methylthioninium

SFDA 2
EMA 2
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Proveblue	5 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 374.05	NCE · Prescription	Provepharm SAS	Valid
Proveblue	5 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 289.25	NCE · Prescription	Provepharm SAS	Valid

EMA European Union — centrally authorised medicines

Methylthioninium chloride Proveblue Provepharm SAS · Authorised · authorised 6 May 2011 · ATC V03AB17

Therapeutic indication (EMA)

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).

Lumeblue (previously Methylthioninium chloride Cosmo) Cosmo Technologies Ltd · Authorised · authorised 19 Aug 2020 · ATC V04CX

Therapeutic indication (EMA)

Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

WHO WHO Model List of Essential Medicines (2025)

4.2. Antidotes and other substances used in poisonings > Specific · core
Acquired methaemoglobinaemia
Parenteral > General injections > IV: 10 mg per mL in 10 mL ampoule

Safety signals and safety-related labeling changes

MHRA 11 Dec 2014 Methylthioninium chloride (methylene blue): update on central nervous system (CNS) toxicity
High intravenous doses of methylthioninium chloride (methylene blue) should be avoided for patients being treated with serotonergic antidepressants (eg, SSRIs, clomipramine, and venlafaxine).

All safety entries for methylthioninium →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.