Firmagon
degarelix
Table of contents
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.
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List item
Firmagon : EPAR - Medicine overview (PDF/144.42 KB)
First published: 04/03/2009
Last updated: 03/11/2021
EMA/435238/2020 -
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List item
Firmagon - Risk-management-plan summary (PDF/89.72 KB)
First published: 24/07/2020
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 |
Product information
30/03/2022 Firmagon - EMEA/H/C/000986 - IAIN/0041
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
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.