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Navamedic ASA: First approval of the medical device OraFID® as primary package for a pharmaceutical product


News provided by

Navamedic ASA

27 Jun, 2025, 12:30 GMT

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OSLO, Norway, June 27, 2025 /PRNewswire/ -- Navamedic announces that the Swedish Medical Products Agency, acting as the Reference Member State, together with the Concerned Member States in 9 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 personalized, fine-tuned treatment with minitablets, and I am thrilled to see the approval of this important milestone." says Kathrine Gamborg Andreassen, Chief Executive Officer of Navamedic.

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.
It is approved as an integral combination product for Flexilev®, Navamedic's medication for the treatment of Parkinson's.

The launch in Nordic markets is anticipated in October 2025.

For further information, please contact:
Kathrine Gamborg Andreassen, CEO, Mobile: +47 951 78 880 E-mail: kathrine@navamedic.com
Lars Hjarrand, CFO, Mobile: +47 917 62 842 E-mail: Lars.Hjarrand@navamedic.com                                              

About Navamedic

Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's quality of life by being a reliable supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies. Our growing product portfolio has been carefully selected to meet current public health concerns, such as obesity, Parkinson's disease, and gastro-related ailments, to empower people to live healthier and more fulfilling lives.

What sets us apart is our deep-rooted commitment to understanding the needs and requirements of the countries where we are present. Our local insight and competence enable us to understand the specific needs of each country where we operate and ultimately to gain market access. This makes us a preferred partner for international companies expanding their footprint across the Nordics and Benelux regions, through either in-licensing or out-licensing. Navamedic has been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is headquartered in Oslo, Norway.

For more information, please visit Navamedic.com 

This information was brought to you by Cision http://news.cision.com

Navamedic ASA: First approval of the medical device OraFID® as primary package for a pharmaceutical product Oslo, Norway - 2025.06.27 - Navamedic announces that the Swedish Medical Products Agency, acting as News Powered by Cision

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