Navamedic has secured final approval for the Flexilev in OraFID tablet dispenser packaging material in the national languages of Norway, Sweden, and Denmark.
OraFID is a patented, entirely mechanical medical device designed to deliver exact amounts of mini tablets to patients with a simple mechanism operated by a few twists of the hands.
The company received the first approval of OraFID as the primary package for a pharmaceutical product in June 2025.
The product licensor, Orion Corporation, has also received final confirmation for the Finnish market.
Navamedic CEO Kathrine Gamborg Andreassen said: “We are excited to have received the last approvals, paving the way for our go-to-market launch in the Nordic region.”
The Flexilev in OraFID dispenser is designed to provide precise and personalised treatment for patients with Parkinson’s, particularly advantageous for medications with a narrow therapeutic window.
Hyper-fractionation, which involves administering smaller, more frequent doses, is made possible through this approach.
Following the acquisition of Sensidose in May 2023, Flexilev, a novel prescription treatment for Parkinson’s disease, became part of Navamedic’s product range.
The launch of OraFID in the Nordic markets is anticipated this October.
Navamedic entered into a licensing and supply agreement with Orion for the distribution of Flexilev, which includes OraFID, across Europe in June 2024.
This agreement excludes Sweden, Norway, Denmark, and Iceland, where Navamedic retains the rights to market and sell the product.
Orion has secured the exclusive rights to market, distribute, and sell Flexilev in 27 European countries, including the five largest markets: Germany, France, Italy, Spain, and the UK.
Orion acts as the marketing authorisation holder within its designated territory and will carry all associated rights and obligations.
