Firmagon

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degarelix

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

Overview

Firmagon is a medicine used to treat cancer of the prostate (a gland of the male reproductive system) in adult men when the cancer is ‘hormone-dependent’, which means that it responds to treatments that reduce the levels of the hormone testosterone. It is used:


• to treat advanced hormone-dependent prostate cancer. ‘Advanced’ means that the cancer has spread beyond the pelvis to nearby tissues such as lymph nodes and bone;


• before or together with radiotherapy to treat high-risk localised or locally advanced hormone-dependent prostate cancer. ‘High-risk localised’ means that the cancer is likely to spread beyond the prostate gland to nearby tissues and become ‘locally advanced’.


Firmagon contains the active substance degarelix.

This EPAR was last updated on 30/03/2022

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
19
Date of issue of marketing authorisation valid throughout the European Union
17/02/2009
Contact address

Amager Strandvej 405
2770 Kastrup
Denmark

Product information

30/03/2022 Firmagon - EMEA/H/C/000986 - IAIN/0041

Product information documents contain:

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.

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.

- for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

- as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Assessment history

Changes since initial authorisation of medicine

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