Leuprorelin

Leuprorelin (Camcevi, Accord Healthcare S.L.U.) has 2 EU-approved indications in 1 tumour type.
Approved indications of Leuprorelin
Biomarker requirementRegimenSettingConditions
Prostate cancer2
None
+ radiotherapy
Any line
High-risk localised or locally advanced; hormone dependent
None
Monotherapy
Any line
advanced
Hormone dependent
Full text of section 4.1 (therapeutic indications)

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.

Label history

7 changes to the Camcevi label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes