Norway-based pharmaceutical company Navamedic (OSE:NAVA) announced on Friday that the Swedish Medical Products Agency, acting as the Reference Member State, together with the Concerned Member States in nine additional countries have approved OraFID for use with a medicinal product.
"OraFID is a unique, fully mechanical medical device that dispenses precise quantities of minitablets to patients. It enables personalised, fine-tuned treatment with minitablets, and I am thrilled to see the approval of this important milestone," said Kathrine Gamborg Andreassen, Navamedic chief executive officer.
The company says that treatments with a narrow therapeutic window can benefit from hyper-fractioning of the dose, by dividing it into minitablets, each containing a fraction of the dose. OraFID works with a couple of twists of the hands and ejects an exact number of minitablets.
OraFID is approved as an integral combination product for Flexilev, Navamedic's medication for the treatment of Parkinson's.
It is anticipated to be launched in Nordic markets in October 2025.
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