EURNEFFY Nasal spray, solution Ref.[115382] Active ingredients: Epinephrine

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: ALK-Abelló A/S, Bøge Allé 6-8, 2970 Hørsholm, Denmark

Product name and form

EURneffy 2 mg nasal spray, solution in single-dose container.

Pharmaceutical Form

Nasal spray, solution.

The solution is clear and colourless to pink brownish.

A solution with a pH of 3.0-5.5 and an osmolality of 325–560 mOsm/kg.

Qualitative and quantitative composition

Each single-dose container delivers adrenaline (epinephrine) 2 mg in 100 microlitres.

Excipients with known effect:

Benzalkonium chloride 40 micrograms per single-dose container.

Sodium metabisulfite 5 micrograms per single-dose container.

For the full list of excipients, see section 6.1.

Active Ingredient

Epinephrine is a direct acting sympathomimetic agent, which exerts effects on both α and β adrenoceptors. It has more pronounced effects on β than on α adrenoceptors, although α effects prevail at high doses. The effects of adrenaline include increased rate and force of cardiac contraction, cutaneous vasoconstriction and broncho-dilatation.
List of Excipients

Sodium chloride
Dodecylmaltoside
Disodium edetate
Benzalkonium chloride
Sodium metabisulphite (E223)
Hydrochloric acid, concentrated (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)
Water for injections

Pack sizes and marketing

Type I glass vials and closed with a grey bromobutyl rubber stopper and then assembled into a Unit

Dose Sprayer (UDS) device. The device is a non-pressurized dispenser delivering a single-dose nasal spray.

Pack size:

Pack of 2 single-dose nasal sprays

Pack of 1 single-dose nasal spray

Not all pack sizes may be marketed.

Marketing authorization holder

ALK-Abelló A/S, Bøge Allé 6-8, 2970 Hørsholm, Denmark

Marketing authorization dates and numbers

EU/1/24/1846/001
EU/1/24/1846/002

Date of first authorisation: 22 August 2024

Drugs

Drug Countries
EURNEFFY Austria, Estonia, Lithuania
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈