Therapy Areas: Devices
Navamedic ASA secures final approvals for Flexilev in OraFID across Nordic markets
13 August 2025 -

Norwegian pharmaceutical company Navamedic ASA (OSE:NAVA) said on Wednesday that it has obtained final approval for packaging materials for Flexilev in OraFID in national languages for Norway, Sweden, and Denmark, completing the regulatory requirements for these markets.

Finnish pharmaceutical company Orion Corporation (HEL:ORNBV), the product licensor for Finland and the European Union, has also received final confirmation for the Finnish market.

Chief Executive Officer Kathrine Gamborg Andreassen stated that the approvals clear the way for the company's market launch in the Nordic region.

The product, Flexilev in OraFID, offers precise and personalised treatment for Parkinson's disease patients, particularly benefiting those requiring hyper-fractionation - smaller, more frequent doses for medications with narrow therapeutic windows. The OraFID patented mechanical device is designed to dispense exact quantities of minitablets through simple manual operation.

Navamedic is targeting an October 2025 launch across the Nordic markets.

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