Basic Information
Degarelix Accord
Regulatory Information
EMEA/H/C/006048
September 29, 2023
July 20, 2023
November 8, 2023
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Degarelix Accord 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.
Overview Summary
Degarelix Accord 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’. Degarelix Accord contains the active substance degarelix and is a ‘generic medicine’. This means that Degarelix Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Degarelix Accord is Firmagon. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf).