Freedom of Information request about information relating to Dioctyl 100 mg Capsules (PL00039/0737) (FOI-21-026)
Published 24 March 2021
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Thank you for your correspondence of 03 January 2021, 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 this product and provide a copy of the Clinical Expert Report that was included in the MAA.”
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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Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF Yours sincerely, The FOI Licensing Team