# Leuprorelin

Leuprorelin (Camcevi, Accord Healthcare S.L.U.) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + radiotherapy | Any line | High-risk localised or locally advanced; hormone dependent |
| None | Monotherapy | Advanced | Hormone dependent |

## Products

### Camcevi

- Company: Accord Healthcare S.L.U.
- Target: GnRH receptor agonist
- EU approval: 24 May 2022
- Label revised: 15 Sep 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/camcevi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/camcevi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/camcevi

Mechanism (SmPC section 5.1): Synthetic nonapeptide GnRH agonist that, given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular steroidogenesis (testosterone production), reversibly.

## Label wording

- **Leuprorelin** (Camcevi), Prostate cancer, advanced: “CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/camcevi-epar-product-information_en.pdf)
- **Leuprorelin** (Camcevi), Prostate cancer, any line: “CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/camcevi-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/leuprorelin