Freedom of Information request about the assessment report for the indication of “symptomatic treatment of severe sialorrhea” for Glycopyrronium Bromide 1mg Tablets (FOI-21-280))
Published 28 May 2021
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In response to your request for a copy of the assessment report for the indication of “symptomatic treatment of severe sialorrhea” for Glycopyrronium Bromide 1mg Tablets (PL 44710/0017), I can confirm that the MHRA does hold this.
We intend to update the Public Assessment Report (PAR) for this product with the assessment of this indication in the near future.
As we plan to publish the assessment report in the near future, your request is refused under Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is, therefore, exempt from disclosure.
Section 22 is a qualified exemption, which means a consideration of the public interest is necessary. We have considered the public interest and cannot see any public interest argument that necessitates MHRA to release the assessment report before this is published in the PAR. Examples of public interest arguments would be a major public health risk, or a major procedural failure or irregularity.
If you have a query about the information provided, please reply to this email.
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Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
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