Germany Approves Trilogy Of Switches
Three prescription-to-OTC switches approved in Germany: Levocetirizine for oral use, diclofenac for use as a patch, and preparations containing sodium bituminosulfonate and hydrocortisone acetate.
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A prescription-to-OTC switch for levocetirizine has opened the door for generic producers such as Sandoz’ Hexal to extend their consumer healthcare allergy offerings in Germany.
EMA’s Frias Defends EU Centralized Switch Procedure Despite Only Delivering Four Reclassifications In 10 Years
Despite delivering only four switches in 10 years, the European Union’s centralized switch procedure was defended by the EMA's Zaide Frias at AESGP's March regulatory conference. Frias pointed to the recent success of HRA Pharma's EllaOne, to the role of pharmacists in driving switches and to the possibility of an OTC Expert Forum as ways forward for the procedure.
Two prescription-to-OTC switch applications rejected by Germany’s Expert Committee for Prescription: preparations containing a combination of ibuprofen and phenylephrine hydrochloride and hydrocortisone 1% for external use.