NYXOID Nasal spray Ref.[27755] Active ingredients: Naloxone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom

Product name and form

Nyxoid 1.8 mg nasal spray, solution in a single-dose container.

Pharmaceutical Form

Nasal spray, solution in a single-dose container (nasal spray).

Clear, colourless to pale yellow solution.

Qualitative and quantitative composition

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 Description
Naloxone

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
Sodium chloride
Hydrochloric acid
Sodium hydroxide
Purified water

Pack sizes and marketing

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.

Marketing authorization holder

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom

Marketing authorization dates and numbers

PLGB 16950/0374

01/01/2021

Drugs

Drug Countries
NYXOID Austria, Australia, Estonia, Ireland, Lithuania, New Zealand, Poland, Romania, United Kingdom

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