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.
