DORMAGEN Tablet Ref.[9821] Active ingredients: Lormetazepam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Genus Pharmaceuticals Holding Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Product name and form

Lormetazepam Tablets 0.5 mg.

or

Dormagen Tablets 0.5mg.

Pharmaceutical Form

Lormetazepam Tablets 0.5mg are round white tablets, 6.5mm in diameter with ‘GP036’ embossed on one side and plain on the other.

Qualitative and quantitative composition

Lormetazepam Tablets 0.5mg contain 0.5mg lormetazepam.

Lormetazepam (INN, BAN) is chemically defined as 7-chloro-5-(2-chlorophenyl)- 1,3-dihydro-3-hydroxy-1-methyl-2H-1,4-benzodiazepin-2-one.

Active Ingredient Description
Lormetazepam

Lormetazepam is a benzodiazepine with anxiolytic, muscle relaxant, sedative and hypnotic properties. Clinical studies have shown minimal effects on REM sleep and on psychomotor performance on the day after treatment with lormetazepam. Lormetazepam is indicated for the short term treatment of insomnia.

List of Excipients

Lactose
Maize starch
Polyvinylpyrrolidone
Magnesium stearate

Pack sizes and marketing

PVC/aluminium foil blister packs: Pack sizes of 28, 30 or 100 tablets.

Opaque polypropylene Securitainers: Pack sizes of 28, 30 or 100 tablets.

Amber glass bottles: Pack sizes of 28, 30 or 100 tablets.

Marketing authorization holder

Genus Pharmaceuticals Holding Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Marketing authorization dates and numbers

PL 17225/0012

10/03/2009

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