Pharmaceuticals and Medical Products Regulatory (MHRA) was used today for emergency treatment of serious allergic reactions, known as ADRENALINE (EPINEPHRINE), on July 18, 2025.
Anaphylaxis is a sudden, serious and sometimes threatening allergic reaction, causing blood pressure and causing breathing difficulties.
Adrenalin is a well -established treatment for anaphylaxis administered through automatic injections. This approval is the introduction of a nasal spray formulation, providing an alternative without a needle for emergency administration of the drug that potentially saves life.
It is intended to be used for adults and children weighing more than 30kg (about 66 pounds).
The patient reminds MHRA’s important public guidelines for how to react to anaphylactic and use adrenaline automatic syringes.
Julian Beach, a temporary director of MHRA medical quality and access, said:
“Because patient safety is our top priority, we are pleased to approve the nasal spray formulation without the first needle of the adrenaline for emergency treatment of anaphylaxis in the UK, and the adrenaline for management has been available only through automatic injections.
“This represents an important new option, while the adrenaline automatic syringe remains a treatment that can save life to save life.
“We recommend that you can use the resource and map so that everyone who is at risk of serious allergic reactions and those around them will be used to the MHRA website so that people can be used to responding to the emergency.”
Adrenaline (epinephrine) nasal spray is a single capacity nasal spray that can be used immediately when it is activated.
Do not press the plunger before inserting the product into the nose hole. Otherwise, a single capacity will be lost before use.
Adrenaline (epinephrine) nasal sprays can also be used when the nose is stagnant due to cold or allergies.
The patient must always carry two nasal sprays if he needs a second dose, and inform his friend or family if an emergency occurs.
The entire list of side effects can be found in the patient information complex (PLE) or product characteristic summary (SMPC) provided on the MHRA website within 7 days of approval.
Like all drugs, MHRA will carefully examine the safety and effects of adrenaline cosspray.
Those who suspect that they have side effects in this drug are recommended to consult a doctor, pharmacist or nurse to report directly to the MHRA Yellow Card System through the website.https://yellowcard.mhra.gov.uk/) Or search for Google Play or Apple App Store of MHRA YELLOW CARD.
This medicine has been approved through the International Cognitive Procedure (IRP). Through IRP, MHRA can consider the expertise and decision -making of trusted regulatory partners for the benefit of British patients.
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Notes to the editor
- The approval was given to Alk-Abelló A/S on July 18, 2025.
- This product has been submitted and approved through the international recognition process.
- MHRA performs the target evaluation of the IRP application and maintains the permission to reject the application if the provided evidence is not considered strong enough.
- For more information, please visit the product characteristic summary and patient information leaflet. MHRA product website Within approval within 7 days.
- Medicine and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating all British drugs and medical devices in all British and medical devices regulating all British and medical devices. All our work is supported by the fact that the benefits can justify the risk and the facts of the foundation.
- MHRA is an enforcement agency of the Ministry of Health and Social Welfare.
- For media inquiries, please contact newsCentre@mhra.gov.uk or 020 3080 7651.
