Freedom of Information request on The marketing authorisation for Karvol (FOI 22/563)
Published 1 June 2022
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FOI 22/563
25th March 2022
Dear
Thank you for your email.
The marketing authorisation for Karvol was cancelled in 2015 at the request of the marketing authorisation holder. In 2020, the EMA’s Safety Working Party (SWP), in response to a request from CMDh, were asked to review whether the levels of chlorobutanol generally used in medicinal products were safe from a toxicological point of view. SWP concluded that chlorobutanol levels used in medicinal products can be considered safe for lifetime use, if they are at or below the derived permitted daily exposure of 0.5 mg/day. For short-term use higher exposures may be acceptable based on case-by-case evaluation. The full SWP position has been published on the EMA website:
SWP response to CMDh request on chlorobutanol - EMA website version (europa.eu)
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