Freedom of Information request on Diltiazem XL 120mg, 180mg and 240mg (FOI 21/1027)
Published 27 April 2022
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4th October 2021
FOI 21/1027
Dear
Thank you for your email, dated 07 September 2021, in which you requested the following information concerning Diltiazem XL 120, 180 and 240 (previously known as Monozem 120 mg, 180 mg and 240 mg Capsules; PL 12295/0001-0003):
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Details of the products’ licensing history/current status, such as whether the licences have been cancelled or transferred to a new Marketing Authorisation Holder (MAH) and, if transferred, the details of the new product licence (PL) numbers.
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clinical data for Diltiazem XL 120, 180 and 240 (PL 12295/0001-0003).
MHRA’s response:
Diltiazem XL 120, 180 and 240 (PL 12295/0001-0003) were approved on 09 May 1994 to Pharmatec International Srl. The Marketing Authorisations underwent Change of Ownerships procedures to Aptalis Pharma s.r.l., (Diltiazem XL 120, 180 and 240 Capsules; PL 05146/0003-0006) on 12 July 2007. The licences for Diltiazem XL 120, 180 and 240 Capsules (PL 05146/0003-0006) were cancelled on 30 October 2008.
We are responding to your request for clinical data for Diltiazem XL 120, 180 and 240 (PL 12295/0001-0003) by providing the attached MHRA clinical report, redacted under Section 40 (Personal Information), Section 41 (Information given in confidence) and Section 43 (Commercial Interests) of the Freedom of Information Act.
Disclosure of information subject to Section 40 (Personal information) would be an infringement of personal data. Section 40 (Personal information) is an absolute exemption and no consideration of the public interest is required.
Section 41 (Information given in confidence) is an absolute exemption, and no consideration of the public interest is necessary, except to state that the release of this information withheld under this section of the FOI Act would be considered an actionable breach by the MHRA.
We have redacted some parts of the attached documentation under Section 43 (Commercial Interests) of the FOI Act because the release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests. We have considered the balance of the public interest when applying this exemption. In this case, we have not identified any issues which would benefit the public, as a whole, by being brought to their attention.
We now consider this FOI request closed. If you have a query about this letter, please contact the MHRA FOI Licensing mailbox using the email address listed below.
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 2 months of the date you receive this response and addressed to: info@mhra.gov.uk, quoting reference FOI 21/1027.
If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, and Cheshire, SK9 5AF.
Yours sincerely,
The FOI Licensing Team