Consultation outcome

Reclassification of Otrivine extra dual relief nasal spray solution (ARM 90)

• From: Medicines and Healthcare products Regulatory Agency
• Published: 25 February 2015
• Last updated: 5 July 2017 — See all updates

This consultation has concluded

Read the full outcome

Otrivine Extra Reclassification Public Assessment Report

MS Word Document, 240 KB

Detail of outcome

The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to reclassify Otrivine Extra Dual Relief Nasal Spray from a prescription only medicine (POM) to a Pharmacy (P) medicine in the UK for the symptomatic treatment of nasal congestion and rhinorrhoea (runny nose) in connection with common colds, in adults 18 years and above.

See the public assessment report for more information.

Feedback received

Guild of Healthcare Pharmacists response

PDF, 811 KB, 2 pages

Royal Pharmaceutical Society response

PDF, 1.35 MB, 3 pages

Medical Rescue Limited Response

PDF, 655 KB, 1 page

Detail of feedback received

A total of 3 responses were received, of which 2 were in favour. 1 provided comments but did not express a view on whether they were in favour or against the proposed reclassification.

See all the responses to the consultation.

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Original consultation

Summary

MHRA is asking for feedback on proposals to change the legal classification of Otrivine extra dual relief nasal spray solution from prescription only medicine (POM) to pharmacy only (P).

This consultation ran from
2pm on 25 February 2015 to 11:59pm on 18 March 2015

Consultation description

This consultation seeks your views on the reclassification from prescription only medicine (POM) to pharmacy only (P) of Otrivine extra dual relief nasal spray solution.

The Commission on Human Medicines has advised that this product can be available as a pharmacy medicine and by considering if:

• this nasal spray contains a new combination of xylometazoline and ipratropium not previously available in the UK
• it is for the symptomatic treatment of both nasal congestion and rhinorrhoea in connection with common colds, in adults 18 years and above
• both substances have well established efficacy and safety profiles and the side effects are considered mild
• further evidence for safe use as a P medicine is based on up to 8 years use as a non-prescription medicine in other EU member states
• the strength of ipratropium is higher than in current UK products, this dose is required for short term treatment of common cold symptoms, the lower strength is for longer term treatment of rhinorrhoea
• patients are able to recognise the symptoms of the common cold and availability under the supervision of a pharmacist will help ensure safe supply

You can comment on the proposal in the document above using the reply form that is included in the document. Feedback on issues not already considered is particularly important.

Comments should be sent to MHRA by 18 March 2015. Comments received after that date will not be considered.

Documents

Consultation document: ARM 90 Otrivine extra dual relief nasal spray solution

PDF, 1.29 MB, 21 pages

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Published 25 February 2015
Last updated 5 July 2017 + show all updates

1. 5 July 2017

   Reclassification

2. 25 February 2015

   First published.