Signifor

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pasireotide

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

Overview

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.

This EPAR was last updated on 11/06/2018

Authorisation details

Product details
Name
Signifor
Agency product number
EMEA/H/C/002052
Active substance
pasireotide
International non-proprietary name (INN) or common name
pasireotide
Therapeutic area (MeSH)
  • Acromegaly
  • Pituitary ACTH Hypersecretion
Anatomical therapeutic chemical (ATC) code
H01CB05
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
24/04/2012
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

12/04/2018 Signifor - EMEA/H/C/002052 - T/0037

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Therapeutic indication

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.

Assessment history

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