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EMA Reviewing Two Centralised Switch Applications

 
• By Tom Gallen

Teva's Ratiopharm and Italy's Recordati have submitted applications to switch drugs from prescription-to-OTC status through EMA's centralised procedure. Given only four products have been switched centrally to date, a double reclassification would be unprecedented. 

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• Source: Shutterstock

Two centralized prescription-to-OTC switch applications are currently under review by the European Medicines Agency for an premature ejaculation treatment and a product to relieve the symptoms of allergic rhinitis. Approvals would see the drugs available OTC throughout the whole of the European Union. 

First, Italy’s Recordati Industria Chimica & Farmaceutica SPA – through its Irish subsidiary – is seeking to change the...

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