METHYLTHIONINIUM CHLORIDE PROVEBLUE Solution for injection Ref.[8668] Active ingredients: Methylthioninium chloride

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: PROVEPHARM SAS, 22 rue Marc Donadille, 13013, Marseille, France

Product name and form

Methylthioninium chloride Proveblue 5 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear dark blue solution with a pH value between 3.0 and 4.5.

Osmolality is usually between 10 and 15 mOsm/kg.

Qualitative and quantitative composition

Each ml of solution contains 5 mg methylthioninium chloride.

Each 10 ml ampoule contains 50 mg methylthioninium chloride.

Each 2 ml ampoule contains 10 mg methylthioninium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methylthioninium chloride

In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin. Methylthioninium chloride has been observed to stain tissues selectively.

List of Excipients

Water for injections

Pack sizes and marketing

Type I glass ampoules.

Each carton contains a tray with 5 ampoules of 10 ml in blister.

Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister.

Not all pack sizes may be marketed.

Marketing authorization holder

PROVEPHARM SAS, 22 rue Marc Donadille, 13013, Marseille, France

Marketing authorization dates and numbers

EU/1/11/682/001
EU/1/11/682/002
EU/1/11/682/003

Date of first authorisation: 06 May 2011
Date of latest renewal: 08 February 2016

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