Consultation outcome

Nuromol Dual Action Pain Relief 200mg/500mg tablets (ibuprofen/paracetamol): public consultation

This consultation has concluded

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Detail of outcome

The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to reclassify Nuromol Dual Action Pain Relief (containing 200mg/500mg (ibuprofen/paracetamol) per tablet) from Pharmacy (P) to General Sale (GSL) for the for the temporary relief of mild to moderate pain, which has not been relieved by ibuprofen or paracetamol individually. See the public assessment report above for more information.

Feedback received

Detail of feedback received

Consultation document ARM 100, which summarises the proposal to reclassify Nuromol Dual Action Pain Relief (containing 200mg/500mg (ibuprofen/paracetamol) per tablet) from Pharmacy (P) to General Sale (GSL) was posted on the GOV.UK website on 13 May 2021. The deadline for comments was 3 June 2021.


Original consultation

Summary

The MHRA is asking for views on a proposal to make Nuromol Dual Action Pain Relief 200mg/500mg tablets (ibuprofen/paracetamol) available without prescription in general sales outlets, such a supermarkets.

This consultation ran from
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Consultation description

Nuromol Dual Action Pain Relief 200mg/500mg tablets used for the 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 adults 18 years and over. Nuromol Dual Action Pain Relief 200mg/500mg tablets are currently licensed as a pharmacy only medicine.

We propose to make it available in general sales outlets, such a supermarkets, without prescription.

The Commission on Human Medicines (CHM) has advised that this product can be available as a General Sales medicine.

We want to know what you think about this change.

Please tell us your views – please use the form below.

The deadline for comments is 3 June 2021.

The full name of the medicine is ‘Nuromol Dual Action Pain Relief 200mg/500mg tablets’ – in these documents, we will call it ‘Nuromol’.

Documents

Annex 1: Response document for MHRA public consultation on the proposal to make Nuromol Dual Action Pain Relief 200mg/500mg tablets available on General Sale

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Annex 2: Nuromol leaflet

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Annex 3: Nuromol label

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Annex 4: Nuromol summary of product characteristics

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.
Published 13 May 2021