ZOLARAM Tablet Ref.[28274] Active ingredients: Alprazolam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Zolaram 0,25 mg Tablets.

Zolaram 0,5 mg Tablets.

Zolaram 1,0 mg Tablets.

Pharmaceutical Form

Zolaram 0,25 mg tablets: White, concave, round tablets, 6.2 mm diameter in size, scored on one side.

Zolaram 0,5 mg tablets: White, concave, round tablets, 9 mm diameter in size, scored on one side.

Zolaram 1,0 mg tablets: White, concave, round tablets, 11 mm diameter in size, scored on one side.

Qualitative and quantitative composition

For Zolaram 0,25 mg: Each tablet contains 0,25 mg of alprazolam.

Excipient(s) with known effect: each tablet also contains 58.50 mg of lactose monohydrate.

For Zolaram 0,5 mg: Each tablet contains 0,5 mg of alprazolam.

Excipient(s) with known effect: each tablet also contains 117.00 mg of lactose monohydrate.

For Zolaram 1,0 mg: Each tablet contains 1,0 mg of alprazolam.

Excipient(s) with known effect: each tablet also contains 234.00 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Alprazolam

Alprazolam, like other benzodiazepines, has a high affinity for the benzodiazepine binding site in the brain. It facilitates the inhibitory neurotransmitter action of gamma-aminobutyric acid, which mediates both pre- and post synaptic inhibition in the central nervous system (CNS).

List of Excipients

Docusate sodium, microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone, potato starch, talc.

Pack sizes and marketing

Zolaram tablets are packed in blisters in a cardboard box containing 3 × 10 tablets.

Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Marketing authorization dates and numbers

Zoralam 0,25 mg tablets: 19739
Zolaram 0,5 mg tablets: 19740
Zolaram 1,0 mg tablets: 14787

Date of first authorisation:

Zolaram 0,25 mg tablets: 4 April 1994
Zolaram 0,5 mg tablets: 28 March 1994
Zolaram 1,0 mg tablets: 29 June 1994

Drugs

Drug Countries
ZOLARAM Cyprus, Hong Kong, Malta

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