HALOPERIDOL Oral solution Ref.[6855] Active ingredients: Haloperidol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Product name and form

Haloperidol Oral Solution BP 5 mg/5 ml.

Pharmaceutical Form

Oral Solution.

Qualitative and quantitative composition

Each 5 ml contains 5 mg of Haloperidol.

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
Methylhydroxybenzoate
Propylhydroxybenzoate
Propylene glycol
Purified water

Pack sizes and marketing

100 ml, 200 ml and 500 ml type III amber glass bottle with 28 × 18 ROPP LDPE plain white or aluminium cap with EPE (expanded polyethylene) wads and epoxy phenolic lacquer or child resistant closures with expanded polyethylene liners.

100 ml, 200 ml and 500 ml high density polyethylene bottle with 28 mm white polypropylene closure.

Not all pack sizes may be marketed.

Marketing authorization holder

Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Marketing authorization dates and numbers

PL 04917/0023

27/02/2007

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