FOI release

Nuromol 200mg/500mg tablets - Environmental Risk Assessment Reports

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2025/00542

Received 3 June 2025

Published 5 August 2025

Request

We are currently working on an ERA for the active substance paracetamol/ibuprofen to be submitted in a procedure for a medicinal product indicated for temporary relief of mild to moderate pain which has not been relieved by ibuprofen or paracetamol individually such as migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, cold and flu symptoms, sore throat and fever. In accordance with Article 7 of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents and in view of the EMA updated Guideline on the environmental risk assessment of medicinal products (EMEA/CHMP/SWP/4447/00 Rev. 1-Corr), we would like to request for all document 1.6 Environmental Risk Assessment reports submitted for the medicinal product Nuromol 200mg/500mg tablets. This request is made with the intention of avoiding unnecessary duplication of environmental studies, in accordance with the principles of animal welfare and the efficient use of resources.

Response

see attached

Documents

• disclosure.zip (1.7 MB)

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