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Navamedic

Regulatory Filings Jun 27, 2025

3668_rns_2025-06-27_4093a610-33da-4acc-afaf-99824a3a999c.html

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

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 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:

[email protected]

Lars Hjarrand, CFO, Mobile: +47 917 62 842 E-mail: [email protected]

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

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