Freedom of Information request (FOI 22/1133)
Published 17 January 2024
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FOI 22/1133
13th December 2022
Dear
Thank you for your communication, dated 23 November 2022, in which you requested the following information:
- The clinical and non-clinical overview for Diazepam RecTubes 10 mg Rectal Solution (PL 29831/0066)
The Marketing Authorisation for Diazepam RecTubes 10 mg Rectal Solution (PL29831/0066) was granted on 02 June 2008, following a change of ownership. The Marketing Authorisation was originally granted to CP Pharmaceuticals Limited (PL 04543/0341) on 14 June 1994. The application was approved under Article 4.8(a)iii of Directive 65/65/EC (a generic application).
We have searched our records (including our archived paper records), for the clinical or non-clinical documentation submitted for the original Marketing Authorisation application for PL 04543/0341; however, we have been unable to obtain this information. Therefore, having exhausted all the usual avenues, we must conclude that this information is no longer in our systems in a retrievable form.
I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at [email protected].
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Yours sincerely,
The FOI Licensing Team