Enorama has submitted the proposed supplements on the MAA to the Swedish MPA


Enorama Pharma announces that proposed supplements to the Marketing Authorization Application (MAA) for each of the Company’s four nicotine products – 2 mg and 4 mg chewing gum with mint and fruit mint flavor respectively – have been submitted July 18 2019, three days before schedule.

“The Swedish Medicines Agency only had comments on proposals for minor changes of editorial nature in the package leaflet and product information, which enabled us to submit our responses before the deadline. Now we are entering the final stage of the process and it is with great expectations that we look forward to the approval of our first pharmaceutical product ”, says Annette Agerskov, Vice President of Enorama Pharma.

Read the full press release in Swedish