US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| MEKINIST | EQ 0.5MG; EQ 2MG | tablet · oral | NOVARTIS | Prescription | 29 May 2013 |
| MEKINIST | EQ 0.05MG BASE/ML | solution · oral | NOVARTIS | Prescription | 16 Mar 2023 |
| MEKINIST | EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | NOVARTIS | Discontinued | 29 May 2013 |
| TRAMETINIB DIMETHYL SULFOXIDE | EQ 0.5MG; EQ 2MG | tablet · oral | HIKMA | Discontinued | 6 Aug 2024 |
EMA European Union — centrally authorised medicines
Spexotras Novartis Europharm Limited · Authorised · authorised 5 Jan 2024 · ATC L01EE01
Therapeutic indication (EMA)
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.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.