Eurneffy - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

epinephrine

Opinion

On 29 January 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Eurneffy. The marketing authorisation holder for this medicinal product is ALK-Abelló A/S.

The CHMP adopted a new strength, 1 mg nasal spray, associated with an extension to the existing indication, as follows:

Eurneffy is indicated in the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise induced anaphylaxis. Treatment is indicated for adults and children aged 4 years and over with a body weight of 15 kg or more ≥30 kg.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

---

Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Eurneffy (EMA/X/0000248440)

Adopted Reference Number: EMADOC-1700519818-2852304

Key facts

• Name of medicine:
  Eurneffy
• EMA product number:
  EMEA/H/C/006139
• Active substance:
  epinephrine
• International non-proprietary name (INN) or common name:
  epinephrine
• Therapeutic area (MeSH):
  Anaphylaxis
• Anatomical therapeutical chemical (ATC) code:
  C01CA24
• Marketing authorisation holder:
  ALK-Abelló A/S
• Date of opinion:
  29/01/2026
• Status:
  Positive