EU/3/17/1910

About

On 23 August 2017, orphan designation (EU/3/17/1910) was granted by the European Commission to Best Regulatory Consulting Ltd, United Kingdom, for sirolimus for the treatment of tuberous sclerosis.

The sponsorship was transferred to FGK Representative Service GmbH, Germany, in March 2019.

Key facts

Active substance
Sirolimus
Medicine name
-
Disease / condition
Treatment of tuberous sclerosis
Date of first decision
23/08/2017
Outcome
Positive
EU designation number
EU/3/17/1910

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

FGK Representative Service GmbH
Heimeranstrasse 35
80339 Munich
Germany
Tel.+49 8989 311928
E-mail: clinical.studies@fgk-rs.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.

How useful was this page?

Add your rating