AKAMON Tablet Ref.[28111] Active ingredients: Bromazepam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Akamon 1.5 mg tablets.

Akamon 3 mg tablets.

Pharmaceutical Form

Tablet.

Akamon 1.5 mg tablets: Yellow, round, flat, scored embossed “MC” tablet

Akamon 3 mg tablets: White, round, flat, scored tablet, embossed “MC”.

Qualitative and quantitative composition

Akamon 1.5 mg tablets: Each tablet contains 1.5 mg bromazepam.

Akamon 3mg tablets: Each tablet contains 3 mg bromazepam.

Excipient(s) with known effect:

1.5mg tablets: lactose monohydrate (79.70mg/tablet) and tartrazine (only for Akamon 1.5mg tablets) (0.50mg/tablet).

3mg tablets: lactose monohydrate (84.4mg/tablet).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bromazepam

Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties.

List of Excipients

Akamon tablets 1.5 mg contain microcrystalline cellulose, lactose monohydrate, powdered cellulose, pregelatinised maize starch, croscarmellose sodium, tartazine lake (E102), colloidal anhydrous silica and magnesium stearate.

Akamon tablets 3 mg contain microcrystalline cellulose, lactose monohydrate, sodium starch glycolate and magnesium stearate.

Pack sizes and marketing

Akamon 1.5 mg tablets: Combination polyvinylchloride – aluminium blisters.

Thirty (30), forty (40) or sixty (60) tablets are contained in a card carton.

Akamon 3 mg tablets: Combination polyvinylchloride – aluminium blisters.

Forty (40), one hundred (100), five hundred (500) and one thousand (1000) tablets are contained in a card carton.

One thousand (1000) tablets are contained in securitainers.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Akamon 1.5 mg tablets: 19858
Akamon 3 mg tablets: 9039

Akamon tablets 1.5 mg tablets: 29/12/2005
Akamon tablets 3 mg tablets: 15/ 09 /83

Drugs

Drug Countries
AKAMON Cyprus, Hong Kong, Malta

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