Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Mundipharma Corporation (Ireland) Limited, United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Nyxoid 1.8 mg nasal spray, solution in a single-dose container.
| Pharmaceutical Form |
|---|
|
Nasal spray, solution in single-dose container (nasal spray). Clear, colourless to pale yellow solution. |
Each nasal spray container delivers 1.8 mg of naloxone (as hydrochloride dihydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Naloxone hydrochloride, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors. It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists, such as pentazocine, for example, but also nalorphine. |
| List of Excipients |
|---|
|
Trisodium citrate dihydrate (E331) |
The immediate container consists of a type I glass vial with siliconised chlorobutyl stopper containing 0.1 ml solution. The secondary packaging (actuator) is comprised of polypropylene and stainless steel.
Each pack contains two single-dose nasal sprays.
Mundipharma Corporation (Ireland) Limited, United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
EU/1/17/1238/001
Date of first authorisation: 10 November 2017
Date of latest renewal: 15 September 2022
| Drug | Countries | |
|---|---|---|
| NYXOID | Austria, Australia, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, New Zealand, Poland, Romania, United Kingdom |
© 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.