Enorama Pharma has submitted requested additions to its MAA to the Swedish Medical Products Agency
29 March 2019
Enorama Pharma AB (publ) ("Enorama Pharma" or "the Company") announces that requested additions to the marketing authorization application 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 March 29 2019, just over four weeks before schedule.
"We are pleased that the Medical Products Agency only came back with additions of minor nature, it shows that our dossier is of good quality and that made it possible for us to reply one month before schedule. Now we look forward to further feedback from the Medical Products Agency so that we can proceed with our European registration process,” says Annette Agerskov, Vice President of Enorama Pharma.
Read the full press release in Swedish