MHRA Clears Lower-Dose EURneffy for Children at Risk of Anaphylaxis

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MHRA Approves First Needle-Free Adrenaline Nasal Spray for Children with Anaphylaxis, Expanding EURneffy Access to Ages 4 and Older

Written By: Chikkula Pavan Kumar, PharmD

Reviewed By: Pharmacally Editorial Team

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new 1 mg dose of EURneffy (adrenaline/epinephrine) nasal spray for the emergency treatment of anaphylaxis in children aged four years and older who weigh between 15 kg and 30 kg. The approval, granted on June 12, 2026, marks the first needle-free adrenaline treatment option available in the UK for younger children at risk of severe allergic reactions.

The authorization expands the use of EURneffy beyond the previously approved 2 mg formulation, which is indicated for adults and children aged 10 years and older weighing at least 30 kg. The new lower-dose product provides an alternative to injectable adrenaline auto-injectors, which have historically been the standard emergency treatment for pediatric anaphylaxis.

Expanding Treatment Options for Pediatric Anaphylaxis

Anaphylaxis is a severe, rapidly developing allergic reaction that can become life-threatening without immediate treatment. Common triggers include foods, insect stings, medications, and other allergens. Clinical guidelines recommend prompt administration of adrenaline at the first signs of anaphylaxis to reduce the risk of serious complications.

EURneffy delivers adrenaline through a single-dose nasal spray, offering a non-invasive alternative to injections. The treatment can be administered directly into the nostril and remains effective even when nasal congestion is present, an important consideration during emergency situations.

The approval broadens access to adrenaline therapy for younger children who may experience anxiety or difficulty with needle-based treatments. Improved ease of administration may also help caregivers respond more quickly during an allergic emergency.

Product Details and Safety Considerations

The newly approved 1 mg formulation is indicated for children aged four years and older weighing between 15 kg and 30 kg. As with adrenaline auto-injectors, patients and caregivers are advised to carry two doses at all times in case a second administration is required before emergency medical services arrive.

Following administration, emergency assistance must still be sought immediately by calling emergency services. Adrenaline provides temporary stabilization of symptoms but does not replace medical evaluation and ongoing care.

The MHRA noted that it will continue to closely monitor the safety and effectiveness of EURneffy through routine pharmacovigilance activities, consistent with other approved adrenaline products.

Implications for Patients and Caregivers

The marketing authorization was granted to ALK-Abelló A/S on June 12, 2026. Updated prescribing information, including the Summary of Product Characteristics (SmPC) and Patient Information Leaflet, is expected to be published on the MHRA Products website within seven days of approval.

The decision strengthens the range of emergency treatment options available for patients with severe allergies in the UK and extends access to a needle-free adrenaline formulation to a younger pediatric population for the first time.

Reference

Lower dose needle-free allergy treatment approved for younger children – GOV.UK

About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.


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