HALOXEN Tablet Ref.[28208] Active ingredients: Haloperidol

Source: Υπουργείο Υγείας (CY)  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, CYPRUS

Product name and form

Haloxen 5 mg tablets.

Haloxen 10 mg tablets.

Pharmaceutical Form

Tablet.

Haloxen 5 mg tablets:

Pink, round, normal convex tablets, scored with Remedica’s logo on one side and “HL 5” on the other side.

The tablet can be divided into equal doses.

Haloxen 10 mg tablets:

Light yellow, round, normal convex tablets, scored with Remedica’s logo on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains haloperidol 5 mg and 10 mg respectively.

Excipient(s) with known effect:

These products contain 113,7 mg and 112,8 mg lactose respectively.

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

Haloxen 5 mg tablets:

Microcrystalline cellulose
Lactose monohydrate
Pregelatinized starch
Colloidal silicon dioxide
Magnesium stearate
Talc
Erythrosine E127
Povidone
Maize starch

Haloxen 10 mg tablets:

Microcrystalline cellulose
Lactose monohydrate
Pregelatinized starch
Colloidal silicon dioxide
Magnesium stearate
Talc
Yellow iron oxide E172
Povidone
Maize starch

Pack sizes and marketing

Haloxen 5 mg tablets: 30, 100 and 1000 tablets in blister packs.

Haloxen 10 mg tablets: 30 and 100 tablets in blister packs.

Not all pack-sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, CYPRUS

Marketing authorization dates and numbers

Haloxen 5 mg tablets: 8589
Haloxen 10 mg tablets: 16307

Haloxen 5 mg tablets:

Date of first authorization: 11 January 1983
Date of latest renewal: 20 November 2009

Haloxen 10 mg tablets:

Date of first authorization: 19 October 1995
Date of latest renewal: 16 January 2012

Drugs

Drug Countries
HALOXEN Cyprus, Malta, Singapore

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.