Enorama Pharma announces that the Company has received approval from the Swedish Medical Products Agency for each of the Company’s four nicotine products – 2 mg and 4 mg chewing gum, respectively, with mint and fruit mint flavor. The application is Enorama’s first medical product that has been registered and approved.
“We have worked hard for several years to reach the market with our products, so it is very gratifying that we can now confirm that we have got our first pharmaceutical product approved. This is our most important milestone so far and it is a proud moment for Enorama. The registration process has followed the expected schedule from the start, which shows that our dossier is of good quality. That we have received a Swedish approval and intend to use Sweden as a reference country in future MRP applications, we see as a quality stamp. The conditions for an early sales start are extremely good”, says Mats Rönngard, CEO of Enorama Pharma.