Firmagon

RSS

degarelix

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 03/08/2018

Authorisation details

Product details
Name
Firmagon
Agency product number
EMEA/H/C/000986
Active substance
degarelix
International non-proprietary name (INN) or common name
degarelix
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BX02
Publication details
Marketing-authorisation holder
Ferring Pharmaceuticals A/S
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
17/02/2009
Contact address
Kay Fiskers Plads 11
DK-2300 Copenhagen S
Denmark

Product information

25/07/2018 Firmagon - EMEA/H/C/000986 - N/0033

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

ENDOCRINE THERAPY

Therapeutic indication

Firmagon is a gonadotrophin-releasing-hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.

Assessment history

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