Freedom of Information request on the clinical overview for Nuromol Dual Action Pain Relief 200mg/500mg tablets (FOI 22/785)
Published 21 December 2023
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FOI 22/785
20th July 2022
Dear
Request a clinical Overview- MA: Nuromol Dual Action Pain Relief 200 mg/500 mg tablets- PL 00063/0649
Thank you for your email, dated 25 June 2022, in which you requested the clinical overview for Nuromol Dual Action Pain Relief 200mg/500mg tablets (PL 00063/0649).
The application for Nuromol Dual Action Pain Relief 200 mg/500 mg tablets (PL 00063/0649) was granted as a national abridged simple application under Article 10(c) of Directive 2001/83/EC, as amended (equivalent to Regulation 56 of The Human Medicines Regulations 2012, as amended) on 17 June 2011. Nuromol Dual Action Pain Relief 200 mg/500 mg tablets (PL 00063/0649), cross-refers to Nuromol Pain Relief 200 mg/500 mg Film Coated Tablets (PL 00063/0579), which was granted a Marketing Authorisation on 15 September 2010.
In response to your request, we are providing the clinical overview for Nuromol Pain Relief 200 mg/500 mg Film Coated Tablets (PL 00063/0579). The documentation has been redacted under Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act.
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. The exemption is to safeguard the commercially sensitive information/commercial enterprise. This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. 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 22/785.
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