HALOPERIDOL Solution for injection Ref.[6854] Active ingredients: Haloperidol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Product name and form

Haloperidol 5mg/ml Solution for Injection.

Pharmaceutical Form

Solution for Injection.

Clear, colourless sterile solution

Qualitative and quantitative composition

Each ml of solution contains Haloperidol 5mg.

Excipient with known effect: Contains sodium less than 1mmol per dose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Haloperidol

Haloperidol is an antipsychotic belonging to the butyrophenones group. It is a potent central dopamine type 2 receptor antagonist, and at recommended doses, has low alpha-1 antiadrenergic activity and no antihistaminergic or anticholinergic activity.

List of Excipients

Lactic acid
Sodium hydroxide (as 10% w/v solution)
Water for injections

Pack sizes and marketing

1ml & 2 ml clear One Point Cut (OPC) glass ampoules, glass type 1 Ph. Eur. borosilicate glass packed in cardboard cartons to contain 10x1ml ampoules and 10x2ml ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Marketing authorization dates and numbers

PL 02848/0127

Date of first authorisation: 27/9/89
Date of last renewal: 18/7/2008

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