FOI release

Freedom of Information request about Adenocor PL 04425/0159 (FOI-21-066)

Published 24 March 2021

Thank you for your email, dated 07 January 2021, in which you requested the assessment reports for Adenocor PL 04425/0159.

A product licence for Adenocor 3 mg/ml Solution for injection (PL 04425/0159) was granted to Aventis Pharma Limited on 31 August 2010, following a series of Change of Ownership procedures (COAs) of Adenocur Injection 6 mg/2 ml (PL 00623/0056; Sanofi UK Limited), previously referred to as Krenosin(e) Injection 6 mg/2 ml. Adenocur Injection 6 mg/2 ml (PL 00623/0056) was granted a product licence on 14 August 1991.

We are responding to your request by providing the attached extract of the redacted scientific paper that was considered at the Committee on Safety of Medicines (CSM, now known as the Commission on Human Medicines (CHM)) meeting held in April 1991 and which contains the MHRA assessment reports for the original application of Adenocor Injection 6 mg/2 ml (PL 00623/0056).

Please note that:

1. all points raised during assessment were satisfactorily resolved prior to the grant of the product licence.
2. the documentation is historical and variation applications may have been submitted subsequently to update some of the information included.

Furthermore, please note the documentation has been redacted under Section 40 (Personal information), Section 41 (Information given in confidence) and Section 43 (Commercial Interests) of the Freedom of Information (FOI) 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. 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 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 21/066.

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 Email: FOILicensing@mhra.gov.uk