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EMA Product

Camcevi

Product approved by European Medicines Agency (EU)

Basic Information

Camcevi

Regulatory Information

EMEA/H/C/005034

Authorised

May 24, 2022

March 24, 2022

5

April 3, 2025

Company Information

Spain

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona

ACCORD HEALTHCARE SL

Active Substances Detail

leuprorelin mesilate

Detailed Information

Therapeutic Indication

### Therapeutic indication 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.

Overview Summary

Camcevi is a medicine used in adult men for the treatment of advanced prostate cancer that is ‘hormone-dependent’, meaning that it responds to treatments that lower the level of the hormone testosterone. Camcevi is also used in combination with radiotherapy to treat locally advanced hormone-dependent prostate cancer and high-risk localised prostate cancer (this means that the cancer is likely to spread beyond the prostate gland to nearby tissues and become ‘locally advanced’). Camcevi is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance but has a different formulation. The reference medicine for Camcevi is Eligard. Camcevi is available as a ready-to-use medicine in contrast with Eligard, which requires pre-mixing before it can be given to the patient. The active substance in Camcevi is leuprorelin.

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