XANAX Tablets Ref.[6145] Active ingredients: Alprazolam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Xanax 500 microgram Tablets.

Pharmaceutical Form

Tablet.

Pink, oval, biconvex tablet scored on one side and marked “Upjohn 55” on the other.

Qualitative and quantitative composition

Each tablet contains 500 micrograms alprazolam.

Excipient(s) with known effect: Lactose, 91.1 mg per tablet.

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

Lactose
Microcrystalline cellulose
Colloidal anhydrous silica
Maize starch
Magnesium stearate
Docusate sodium with sodium benzoate

Pack sizes and marketing

Clear PVC/aluminium foil blister strips of 10 tablets, packed 6 strips to a box.

Glass bottle with metal screw cap or HDPE bottle with LDPE tamper evident cap containing 100 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/1059

Date of first authorisation: 27 August 1982
Date of latest renewal: 23 January 2003

Drugs

Drug Countries
XANAX Canada, Cyprus, Ecuador, Estonia, France, Hong Kong, Ireland, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

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