Freedom of Information request about assessment reports for the medicinal products Adenocor 3mg/ml Solution for injection (PL 11723/0005) and Adenoscan 30 mg/10 ml, solution for infusion (PL 11723/0086) (FOI-21-069)
Published 24 March 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-1-february-2021/freedom-of-information-request-about-assessment-reports-for-the-medicinal-products-adenocor-3mgml-solution-for-injection-pl-117230005-and-adenosca
Thank you for your email dated 07 January 2021 requesting the following information for the above referenced products:
“Please provide the assessment reports for Adenosine PL 11723/0005 and PL 11723/0086.”
The application for the medicinal product Adenocor 3mg/ml Solution for injection was first authorised to the marketing authorisation holder (MAH), Sanofi UK Limited (PL 00623/0056) on 14 August 1991 and subsequently underwent changes of ownership procedures to the MAH, SanofiSynthelabo Limited (PL 11723/0005) on 19 September 1993 and the current MAH, Aventis Pharma Limited (PL 04425/0159) on 31 August 2010.
The application for the medicinal product Adenoscan 30 mg/10 ml, solution for infusion was first authorised to the MAH, Sanofi-Synthelabo Limited (PL 11723/0086) and underwent a change of ownership procedure to the current MAH, Aventis Pharma Limited (PL 04425/0682) on 20 July 2011.
Please find enclosed the MHRA (formerly MCA) assessment reports for the original application of Adenocor 3mg/ml Solution for injection product (PL 00623/0056) and Adenoscan 30 mg/10 ml, solution for infusion (PL 11723/0086).
In addition, please note that:
- all points raised were satisfactorily resolved prior to the grant of the product licence.
- the documentation is historical and variation applications may have been submitted subsequently to update some of the information included.
Redactions have been made to the 2 documents supplied under Section 40 (Personal information), Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom Of Information (FOI) Act 2000.
Section 40 – Personal information: Section 40 protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information. Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.
Section 43 – Commercial interests: You will also notice that we have redacted parts of the attached documents under Section 43 (Commercial Interests) of the Freedom of Information Act. This is 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. In this case, release of information would enable the competitors to overcome several regulatory hurdles in the research and development of their own products. We have considered the balance of the public interest when applying this exemption. 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. 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 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 of receipt of the response to your original letter and should be addressed to MHRACustomerServices@mhra.gov.uk, quoting reference FOI 21/069.