Fortacin set for centralised OTC switch in Europe

Fortacin set for centralised OTC switch in Europe

24 July 2020 - Deborah Wilkes

Recordati’s Fortacin (lidocaine and prilocaine) is set to become the fifth medicine to gain non-prescription status through the European Union’s centralised authorisation procedure.

Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended on 23 July 2020 that Fortacin could be switched from prescription to non-prescription status. The recommendation now has to be approved by the European Commission.

Fortacin is indicated for the treatment of primary premature ejaculation in adult men.

Switching through the centralised authorisation procedure gives a medicine non-prescription status in all member states of the European Union.

Only four centralised switches to date

To date, only four companies have gained non-prescription status for a medicine through the European Union’s centralised authorisation procedure.

GlaxoSmithKline Consumer Healthcare was the first in January 2009 with its Alli (orlistat) weight-loss medicine, followed by Nycomed with its 20mg pantoprazole tablets a few months later. Pfizer/AstraZeneca gained non-prescription status for Nexium Control (esomeprazole) in 2014, and HRA Pharma became the fourth with ellaOne (ulipristal acetate) in 2015.

Fortacin is not the only centralised switch in the pipeline. Teva’s Ratiopharm business is seeking to switch Desloratadine ratiopharm, which is used to relieve the symptoms of allergic rhinitis or urticaria (click here to read the News story).

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