FOI release

Freedom of Information request on The marketing authorisation for Karvol (FOI 22/563)

Published 1 June 2022

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)

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Pandemic situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000