HYPNOVEL Solution for injection Ref.[49988] Active ingredients: Midazolam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

Product name and form

Hypnovel 10mg/2ml solution for injection.

Pharmaceutical Form

Solution for injection.

Qualitative and quantitative composition

Active ingredient: midazolam as hydrochloride.

Ampoules 10mg/2ml; for i.v., i.m. and rectal administration.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Midazolam

Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of midazolam to form water-soluble salts with acids.

List of Excipients

Sodium chloride
Hydrochloric acid
Sodium hydroxide
Water for injection

Pack sizes and marketing

Clear glass 2ml ampoules.

Marketing authorization holder

Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

Marketing authorization dates and numbers

PL 45043/0037

Date of first authorisation: 8 December 1982
Date of latest renewal: 22 April 1998

Drugs

Drug Countries
HYPNOVEL Ireland, United Kingdom

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