Germany turns down OTC switch for adapalene
Τρίτη 26 Ιαν 2016
Germany's Expert Committee for Prescription has rejected an application to switch medicines containing adapalene from prescription to non-prescription status for treating acne.

The committee considered switching monopreparations containing the topical retinoid to pharmacy-only status at a meeting on 19 January 2016. The application was rejected by a majority of the committee.

The proposed switch involved topical formulations containing not more than 0.1% adapalene in pack sizes of up to 25g. It covered treatment of acne on the face when "comedones predominate and papules and pustules are present".

Adapalene is the single active ingredient of Galderma's Differin. It is also present in the company's combination medicine Epiduo, which contains benzoyl peroxide as well as adapalene.

The committee's recommendation has to be approved by the German health ministry and the upper house of parliament, the Bundesrat.

Πηγή:  OTC Tool Box

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