OXAZEPAM Tablet Ref.[10949] Active ingredients: Oxazepam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Tillomed Laboratories Limited, 220 Butterfield, Great Marlings, Luton, LU2 8DL, UK

Product name and form

Oxazepam 10 mg Tablets.

Pharmaceutical Form

Tablet.

White round flat tablet with a score line on one side and coded OXA 10 on the other side.

The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Each tablet contains 10mg of Oxazepam.

Excipient with known effect: Each tablet contains 100 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Oxazepam

Oxazepam is a synthetic benzodiazepine derivative with anxiolytic and sedative hypnotic properties. Although the mechanism of action has not been fully elucidated, oxazepam appears to enhance gamma-aminobutyric acid (GABA) receptor affinity for GABA, thereby prolonging synaptic actions of GABA.

List of Excipients

Lactose
Maize Starch
Pregelatinised Maize Starch
Magnesium Stearate

Pack sizes and marketing

A polypropylene tubular container with a tamper-evident tear strip in pack sizes of: 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250, 500 and 1000 tablets or PVdC coated PVC/Aluminium blisters (40g/m2 PVdC on 250ยตm PVC/25ยตm A1) in pack sizes of: 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Tillomed Laboratories Limited, 220 Butterfield, Great Marlings, Luton, LU2 8DL, UK

Marketing authorization dates and numbers

PL 11311/0526

Date of first authorization: 22/10/1979

Date of latest renewal: 16/12/2008

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