ORAP Tablet Ref.[8505] Active ingredients: Pimozide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Eumedica S.A., Winston Churchill Avenue 67, BE-1180 Brussels, Belgium

Product name and form

Orap 4 mg tablets.

Pharmaceutical Form

Tablet.

Green, circular, biconvex, normally arched tablets, single-scored on one side and ‘ORAP 4’ on the other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains pimozide 4 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Pimozide

Pimozide is an orally active neuroleptic drug which blocks central dopaminergic receptors. Pimozide antagonises many of the actions of amphetamine and apomorphine.

List of Excipients

Calcium hydrogen phosphate dihydrate
Maize starch
Microcrystalline cellulose
Polyvidone K30
Talc
Cottonseed oil hydrogenated
Ferric oxide (E172)
Indigotindisulphonate (E132) - aluminium lake
Purified water*

* not in final product

Pack sizes and marketing

PVC/aluminium foil blister packs, containing 28*, 100 or 250* tablets.

* not marketed

Marketing authorization holder

Eumedica S.A., Winston Churchill Avenue 67, BE-1180 Brussels, Belgium

Marketing authorization dates and numbers

PL 21772/0004

Date of first authorisation: 14 June 1976
Date of latest renewal: 7 April 2002

Drugs

Drug Countries
ORAP Brazil, Germany, Estonia, Spain, France, Malta, Netherlands, Tunisia, United Kingdom, South Africa

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