Lumeblue (previously known as Methylthioninium chloride Cosmo)


methylthioninium chloride

This medicine is authorised for use in the European Union.


Methylthioninium chloride Cosmo is used in adults as a dye to help doctors see the lining of the colon (large bowel) more clearly and improve detection of lesions (abnormalities) during colonoscopy, a procedure to examine the colon through a tube with a camera.

Methylthioninium chloride Cosmo contains the active substance methylthioninium chloride.

Methylthioninium chloride Cosmo is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but the authorised use, strength, pharmaceutical form and route of administration are different. The reference medicine for Methylthioninium chloride Cosmo is Metilénkék Pharmamagist, a medicine authorised in Hungary.

This EPAR was last updated on 18/09/2023

Authorisation details

Product details
Lumeblue (previously known as Methylthioninium chloride Cosmo)
Agency product number
Active substance
methylthioninium chloride
International non-proprietary name (INN) or common name
methylthioninium chloride
Therapeutic area (MeSH)
  • Colorectal Neoplasms
  • Colonoscopy
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Alfasigma S.p.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Via Ragazzi del '99, n.5
40133 Bologna

Product information

11/09/2023 Lumeblue (previously known as Methylthioninium chloride Cosmo) - EMEA/H/C/002776 - II/0004

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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

Other diagnostic agents

Therapeutic indication

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

Assessment history

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