Freedom of Information request on the Marketing Authorisation Application for Dioctyl 100 mg Capsules (FOI 22/367)
Published 31 May 2022
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FOI 22/367
14th February 2022
Dear
Thank you for your correspondence of 18th January, in which you requested the following information relating to Dioctyl 100 mg Capsules (PL 00039/0737):
“Please can you advise the legal basis of the original MAA for Dioctyl 100 mg Capsules and provide a copy of the Clinical Expert Report that was included in the MAA that will help us in planning of the bioequivalence study.”
The licence for Dioctyl 100 mg Capsules (currently PL 00039/0737; UCB Pharma Limited following a change of ownership procedure) was granted on 04 May 1993 to Schwarz Pharma Limited (PL 04438/0032).
The application for Dioctyl 100 mg Capsules was submitted as a 4.8 (a)( hybrid) application, which is considered to be equivalent to Article 10(3) of Directive 2001/83/EC, as amended.
Please find attached a copy of the clinical expert report.
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,
MHRA Customer Experience Centre