Lumeblue (previously known as Methylthioninium chloride Cosmo)
methylthioninium chloride
Table of contents
Overview
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.
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Methylthioninium chloride Cosmo : EPAR - Medicine overview (PDF/121.25 KB)
First published: 26/08/2020
Last updated: 16/06/2021
EMA/352818/2020 -
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Methylthioninium chloride Cosmo : EPAR - Risk-management-plan summary (PDF/48.27 KB)
First published: 26/08/2020
Authorisation details
Product details | |
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Name |
Lumeblue (previously known as Methylthioninium chloride Cosmo)
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Agency product number |
EMEA/H/C/002776
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Active substance |
methylthioninium chloride
|
International non-proprietary name (INN) or common name |
methylthioninium chloride
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
V04CX
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Publication details | |
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Marketing-authorisation holder |
Alfasigma S.p.A.
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
19/08/2020
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Contact address |
Via Ragazzi del '99, n.5 |
Product information
11/09/2023 Lumeblue (previously known as Methylthioninium chloride Cosmo) - EMEA/H/C/002776 - II/0004
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
Therapeutic indication
Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.