The Swedish Medicines Agency will be the reference member state for Moberg Pharma’s European registration application
STOCKHOLM, 23 December 2021 / PRNewswire / – The Medical Products Agency in Sweden has agreed to be the reference member state for Moberg Pharma AB’s registration application for MOB-015 (nail fungus treatment). The company will submit the registration application in Europe through the decentralized process, and market approval is expected in 2023.
Moberg Pharma will submit a complete application that provides the opportunity for data exclusivity in Europe for up to 10 years after market approval. Moberg Pharma has been ready to submit the registration application as soon as the authority can receive it. Due to limited resources and many parallel ongoing applications, the Medical Products Agency has now announced that the application can be submitted March 2022. The company’s goal is unchanged, to get its first market approval and launch MOB-015 2023.
“We are advances towards the company’s goal of registering a new and improved nail fungus drug. The need for a treatment alternative that can really cure the nail infection is great, which means that MOB-015 can achieve a unique position due to its high fungicidal effect,“says Anna Ljung, CEO of Moberg Pharma AB.
CONTACT:
For further information, please contact:
Anna Ljung, CEO, phone: +46 707 66 60 30, e-mail: [email protected]
About this information
This information is information that Moberg Pharma AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the above contact persons, for publication at 8.00 CET on 23 December 2021.
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SOURCE Moberg Pharma