Methylthioninium chloride Cosmo

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methylthioninium chloride

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/08/2020

Authorisation details

Product details
Name
Methylthioninium chloride Cosmo
Agency product number
EMEA/H/C/002776
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
V04CX
Publication details
Marketing-authorisation holder
Cosmo Technologies Ltd
Date of issue of marketing authorisation valid throughout the European Union
19/08/2020
Contact address

Riverside II
Sir John Rogerson’s Quay
Dublin 2
Ireland

Product information

19/08/2020 Methylthioninium chloride Cosmo - EMEA/H/C/002776 -

Contents

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Pharmacotherapeutic group

Other diagnostic agents

Therapeutic indication

Methylthioninium chloride Cosmo 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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