CIPRALEX Oral drops, solution

Active ingredients: Escitalopram

Product name and form

CIPRALEX 20 mg/ml oral drops, solution.

Pharmaceutical Form

Oral drops, solution.

Clear, nearly colourless to yellowish solution with a bitter taste.

Qualitative and quantitative composition

Each ml of solution contains: 20 mg escitalopram (as 25.551 mg escitalopram oxalate).

Each drop contains 1 mg escitalopram.

Excipients with known effect: each drop contains 4.7 mg ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity.

List of Excipients

Propyl gallate
Citric acid anhydrous
Ethanol 96%
Sodium hydroxide
Purified water

Pack sizes and marketing

15 ml in a brown glass bottle with dropper applicator (polyethylene), and child-proof screw cap (polypropylene).

Marketing authorization holder

H. Lundbeck A/S, Ottilavaj 9, 2500 Valby, Denmark

Marketing authorization dates and numbers

PL 13761/0028

Date of first authorisation: 03 January 2008
Date of latest renewal: 11 December 2011

Drugs

Drug
Countries
Austria, Canada, Cyprus, Germany, Spain, Lithuania, United Kingdom