National Approval for MOB-015 in Sweden Declared by Moberg Pharma AB

Moberg Pharma AB, a Swedish pharmaceutical company, has received national approval in Sweden for its drug MOB-015. MOB-015 is a topical treatment for onychomycosis, a fungal infection of the nails. The approval allows the drug to be marketed and sold in Sweden, potentially providing a new treatment option for patients suffering from this common condition. Moberg Pharma plans to launch MOB-015 in Sweden in the second half of 2021 and is also seeking approval for the drug in other countries, including the United States..

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Moberg Pharma AB announced that MOB-015 has received national approval for the company’s home market, Sweden, for the treatment of mild to moderate fungal infections of the nails in adults. This is the second country to grant national approval for MOB-015, following the approval in Ireland announced July 31st, and Sweden is the first country where MOB-015 has been approved for over-the-counter (OTC) use. Grant of market authorization in Sweden is significant as commercialization rollout is planned to start in home market.

The company will initiate the launch as quickly as possible and expect to initiate launch preparations in Sweden before the end of the year. National approvals follow the completion of the decentralized procedure with a positive outcome, where MOB-015 was recommended for national approval in 13 European countries. The following countries are included: Austria, Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, Netherlands, Norway, Spain and Sweden.

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Currently, national implementation in each country and granting of marketing authorizations including OTC-approvals when applicable, is ongoing. National approvals are expected to occur in the coming months and timelines may vary between countries.

Moberg Pharma AB has received national approval in Sweden for its product MOB-015, which is used to treat mild to moderate fungal infections of the nails in adults. This is the second country to grant approval for MOB-015, following Ireland. Sweden is also the first country where MOB-015 has been approved for over-the-counter use. The company plans to start the commercialization rollout in Sweden and expects to begin launch preparations before the end of the year. MOB-015 has also been recommended for national approval in 13 other European countries, with national implementation and marketing authorizations ongoing.

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