OJEMDA Powder for oral suspension Ref.[116575] Active ingredients: Tovorafenib

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Ipsen Pharma, 70 rue Balard, 75015 Paris, France

Product name and form

Ojemda 25 mg/ml powder for oral suspension.

Pharmaceutical Form

Powder for oral suspension.

White to off-white powder.

Qualitative and quantitative composition

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
Cellulose, microcrystalline
Mannitol (E421)
Sodium Lauril sulfate
Simeticone
Maltodextrin
Silica, colloidal anhydrous
Sucralose
Artificial strawberry flavour (containing maltodextrin, triacetin, artificial flavour)

Pack sizes and marketing

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.

Marketing authorization holder

Ipsen Pharma, 70 rue Balard, 75015 Paris, France

Marketing authorization dates and numbers

EU/1/26/2025/004

Drugs

Drug Countries
OJEMDA United States

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