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Why Did Germany Reject Sildenafil OTC Switch?

 
• By David Ridley

Sildenafil was rejected at Germany’s independent switch committee’s most recent meeting. HBW Insight examines some of the arguments for and against the switch put forward by the regulator, members of the committee and the applicant, as recorded in the recently published minutes.

Rejected
• Source: Shutterstock

Germany’s medicines regulator BfArM recently published the minutes of its most recent Expert Committee on Prescription meeting, at which the Rx-to-OTC switch of erectile dysfunction treatment sildenafil (50mg) was discussed.

The switch was rejected, this much we know from the “short notice” published in January immediately after the meeting. But with the summary minutes we know have some idea why the switch was unsuccessful

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