LEXOTAN Tablet Ref.[6636] Active ingredients: Bromazepam

Source: Health Products Regulatory Authority (IE)  Revision Year: 2025  Publisher: Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Product name and form

Lexotan 1.5 mg Tablets.

Pharmaceutical Form

Tablet.

Off white to slightly yellow, cylindrical, biplane tablets scored on one side and marked 1.5 on the reverse.

The tablets can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 1.5 mg bromazepam.

Excipient(s) with known effect: Also contains 96.1 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient

Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties.

List of Excipients

Microcrystalline cellulose
Lactose monohydrate
Magnesium stearate
Talc

Pack sizes and marketing

PVDC blister packs of 4, 10, 20, 60 or 100 tablets.

HDPE bottles of 100 tablets.

PVC blister packs of 30 tablets.

PVC/PVDC/aluminium blister packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Marketing authorization dates and numbers

PA2239/008/001

Date of first authorisation: 31 October 1980
Date of last renewal: 31 October 2010

Drugs

Drug Countries
LEXOTAN Australia, Brazil, Ecuador, Hong Kong, Ireland, Japan, Malta, Mexico, Poland, Singapore, South Africa

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