EU/3/07/522

Table of contents

About

This medicine is now known as imisopasem manganese.

On 31 January 2008, orphan designation (EU/3/07/522) was granted by the European Commission to Celtic Bio-Pharma Services Ltd, United Kingdom, for (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-κN5, κN13, κN18, κN21, κN22]-), for the prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy.

In December 2016, Celtic Bio-Pharma Services Ltd. changed name to Kinesys Consulting Ltd.

The sponsorship was transferred to R Best Regulatory Consulting Ltd, United Kingdom, in May 2018.

The sponsorship was transferred to PharmaBio Consulting, Germany, in May 2019.

Key facts

Active substance
(Manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-κN5, κN13, κN18, κN21, κN22]-) (misopasem manganese)
Disease / condition
Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy
Date of first decision
31/01/2008
Outcome
Positive
EU designation number
EU/3/07/522

Sponsor's contact details

PharmaBio Consulting
Immentalstrasse 22
Herdern
79104 Freiburg Im Breisgau
Baden-Wuerttemberg
Germany
Tel. +49 7616 129452
E-mail: info@pharma-bio.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;

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