CIPRALEX Oral drops, solution Ref.[6768] Active ingredients: Escitalopram

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: H. Lundbeck A/S, Ottilavaj 9, 2500 Valby, Denmark

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

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
CIPRALEX Austria, Canada, Cyprus, Germany, Estonia, Spain, Finland, Israel, Italy, Lithuania, Malta, Romania, Turkey, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.