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.
Predictmedix AI launches mobile diabetes screening platform in India
Navamedic's medical device OraFID approved as primary package for a pharmaceutical product
Speranza Therapeutics partners with Sunshine Labs for harm reduction solutions
Immuno Cure and PharmaJet collaborate for novel HIV therapeutic DNA vaccine advancement
GRAIL reports positive results from Galleri multi-cancer early detection test registrational study
InspireMD secures CE Mark approval for CGuard Prime EPS under European MDR
Crossject advances paediatric development of ZEPIZURE Junior for epilepsy crisis management
Creo Medical secures FDA clearance for SpydrBlade Flex in US market
Tissue Regenix secures CE and UKCA certifications for OrthoPure XT
Terumo Corporation expands stroke portfolio in EMEA with SOFIA Flow 88 catheter launch
Crossject advances ZENEO manufacturing with scalable aseptic filling module ahead of product rollout
ZYLOX Unicorn Vascular Closure Device approved in Indonesia
Mindray unveils BeneVision V Series at Euroanaesthesia 2025, advancing precision monitoring
Unicon Pharma and VRR Life Sciences partner support digital transformation in life sciences