Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Ipsen Pharma, 70 rue Balard, 75015 Paris, France
Ojemda 25 mg/ml powder for oral suspension.
| Pharmaceutical Form |
|---|
|
Powder for oral suspension. White to off-white powder. |
One bottle of Ojemda contains 300 mg of tovorafenib. After reconstitution, one bottle of oral suspension delivers 12 ml of tovorafenib at a concentration of 25 mg/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Tovorafenib is a central nervous system (CNS) penetrant, selective small molecule Type II RAF kinase inhibitor of mutant BRAF V600E, wild-type BRAF, and wild-type CRAF kinases, including RAF monomers and dimers and BRAF fusion, suppressing activation of the mitogen-activated protein kinase (MAPK) pathway. |
| List of Excipients |
|---|
|
Copovidone |
30 ml clear Type III glass bottle with induction-seal and a white polypropylene cap.
Each pack contains one bottle, a 20 ml oral dosing syringe, and a bottle adaptor.
Ipsen Pharma, 70 rue Balard, 75015 Paris, France
EU/1/26/2025/004
| Drug | Countries | |
|---|---|---|
| OJEMDA | United States |
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