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SMC ID Date Medicine Submission Type Indication
SMC2667 09/09/2024 dabrafenib (Finlee) Full
  • In combination with trametinib for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600 mutation who require systemic therapy.

  • In combination with trametinib for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600 mutation who have received at least one prior radiation and/or chemotherapy treatment.
SMC2328 08/03/2021 trametinib (Mekinist) Abbreviated

For treatment in combination with dabrafenib (Tafinlar) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. This is an abbreviated submission to remove the SMC restriction to first-line treatment.
SMC2131 11/02/2019 dabrafenib (Tafinlar) Full In combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection
1264/17 10/07/2017 trametinib 0.5mg, 2mg film-coated tablets (Mekinist) Non submission In combination with dabrafenib for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
1161/16 12/09/2016 trametinib (Mekinist) Full In combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

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