This is a summary of the European public assessment report (EPAR) for Signifor. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Signifor.
For practical information about using Signifor, patients should read the package leaflet or contact their doctor or pharmacist.
Signifor : EPAR - Summary for the public (PDF/79.11 KB)
First published: 01/06/2012
Last updated: 20/11/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Recordati Rare Diseases
|Date of issue of marketing authorisation valid throughout the European Union||
Immeuble le Wilson
08/08/2022 Signifor - EMEA/H/C/002052 - IA/0061
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.
Pituitary and hypothalamic hormones and analogues
Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.
Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.