TEMELOR Tablet Ref.[50421] Active ingredients: Lorazepam

Revision Year: 2022  Publisher: Medochemie Ltd., 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Product name and form

Temelor 0.5 mg tablets.

Temelor 1 mg tablets.

Temelor 2.5 mg tablets.

Pharmaceutical Form

Tablet.

Temelor 0.5 mg: White, round with rounded edge tablets, diameter about 4.7 mm.

Temelor 1 mg: white, round, flat, bevelled, scored tablets, with “1.0” inscription, diameter about 6.4 mm. The tablet can be divided into equal doses.

Temelor 2.5 mg: white, round, flat, bevelled, scored, tablets, diameter about 9.1 mm. The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains lorazepam 0.5 mg.

Each tablet contains lorazepam 1 mg.

Each tablet contains lorazepam 2.5 mg.

Excipient with known effect: lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Lorazepam

Lorazepam is a benzodiazepine with anxiolytic, sedative and hypnotic properties.

List of Excipients

Lactose monohydrate
Povidone (K30)
Crospovidone, Type A
Maize starch
Cellulose microcrystalline, E460
Sodium starch glycolate (type A)
Polacrilin potassium
Magnesium stearate, E572

Pack sizes and marketing

Lorazepam 1 and 2.5 mg: Blisters of opaque PVC/PE/PVDC – Aluminium or blisters of Aluminium – Aluminium.

Lorazepam 0.5 mg: Blisters of Aluminium – Aluminium.

Packs containing: 10, 14, 15, 20, 28, 30, 50, 60, 90, 100 and (hospital/pharmacy only) 500 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd., 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Temelor 0.5 mg tablets – MA032/14503
Temelor 1 mg tablets – MA032/14501
Temelor 2.5 mg tablets – MA032/14502

Date of first authorisation: 3rd February 2022

Drugs

Drug Countries
TEMELOR Cyprus, Estonia, Malta, Romania

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