Spexotras (trametinib)
- Region
- 🇪🇺 EU
- Active substance
- trametinib
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Glioma
- CHMP opinion
- Thu 09 Nov 2023
- EU approval
- Fri 05 Jan 2024
- Designations
- Orphan
- Application
- EMEA/H/C/005886
- ATC
- L01EE01
- Official record
- www.ema.europa.eu
Indication
Low-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mekinist Authorised · Novartis Europharm Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.