The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 15 December 2025, approved the reclassification of fluticasone propionate (Pirinase Allergy 0.05% w/w Nasal Spray), making it available directly from behind pharmacy counters, without the need for a prescription, for adolescents aged 12 years and over.
When sales begin in February 2026 it will become the first intranasal corticosteroid to be sold by pharmacists to adolescents from 12 years in Europe.
Currently intranasal corticosteroids are only available over the counter for adults aged 18 years and over.
Fluticasone propionate is used to prevent and relieve the symptoms of allergic rhinitis, including hay fever and other airborne allergies. These symptoms can include a blocked nose, sneezing, runny or itchy nose, watery or itchy eyes, and sinus discomfort.
The decision follows advice from the Commission on Human Medicines (CHM), the government’s independent scientific advisory body, which reviewed the evidence and concluded that the medicine can be supplied safely to adolescents from 12 years, under the supervision of a pharmacist.
Dr Ravina Barrett, Self Medication and Reclassification Team Lead at the MHRA, said
Keeping patients safe and enabling their access to high quality, safe and effective medicines are key priorities for us.
Corticosteroid nasal sprays can provide fast and effective relief to the millions of people who suffer from airborne allergies including hay fever.
This pharmacy-only availability means that parents and carers can now access treatment for adolescents without the need for a prescription.
By widening access, this reduces the reliance on GP appointments for allergy management, freeing up GPs to focus on primary care priorities, aligning with the NHS Long Term Plan by delivering more care in the community and improving overall patient access.
Dr Gary Stiefel, chair of the Allergy UK Health Advisory Board and a consultant in paediatric allergy, said
Fluticasone proportionate 0.05% nasal spray is extremely safe and can be very effective if used alone or in conjunction with non-sedating antihistamines for the treatment of hay fever.
Its use in children from 12 years of age will significantly help large numbers of children who suffer from hay fever and we are supportive of this additional medicine.
It is important to ensure that young people are shown how to use the device correctly.
A full list of side effects for the product can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC).
The product should not be used for more than three months continuously. If needed for longer than this, then patients are advised to see their doctor.
As with all medicines, the MHRA will continue to monitor the safety and effectiveness of Pirinase Allergy 0.05% w/w Nasal Spray.
Anyone experiencing suspected side effects is encouraged to report them through the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk or via the Yellow Card app.
Notes to editors
-
The variation to the existing marketing authorisation of Pirinase Allergy 0.05% w/w Nasal Spray was granted on 15December 2025 to Haleon PLC.
-
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
-
More information regarding the classification of medicine in the UK and the reclassification process can be found here.
-
Hay fever is very common. According to Allergy UK data, as of 2021 it affected 10 to 15% of children and 26% of adults in the UK.
-
The updated Patient Information Leaflet for the product will be uploaded to his page shortly. More information about hay fever / seasonal allergic rhinitis is available here.
-
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
-
The MHRA is an executive agency of the Department of Health and Social Care.
-
For media enquiries, please contact the [email protected], or call on 020 3080 7651.