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SMC ID Date Medicine Submission Type Indication
SMC2940 08/06/2026 darolutamide (Nubeqa) Non submission

Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

SMC2604 09/10/2023 darolutamide (Nubeqa) Resubmission

Treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

SMC2297 09/11/2020 darolutamide (Nubeqa) Full

For the treatment of adult men with non-metastatic castration resistant prostate cancer who are at high risk of developing metastatic disease.

No medicines have been found.