CIRCADIN Prolonged-release tablet Ref.[7312] Active ingredients: Melatonin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: RAD Neurim Pharmaceuticals EEC SARL, 4 rue de Marivaux, 75002 Paris, France, e-mail: regulatory@neurim.com

Product name and form

Circadin 2 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

White to off-white, round, biconvex tablets.

Qualitative and quantitative composition

Each prolonged-release tablet contains 2 mg melatonin.

Excipient with known effect: each prolonged-release tablet contains 80 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Melatonin

Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin. Physiologically, melatonin secretion increases soon after the onset of darkness, peaks at 2-4 am and diminishes during the second half of the night. Melatonin is associated with the control of circadian rhythms and entrainment to the light-dark cycle. It is also associated with a hypnotic effect and increased propensity for sleep.

List of Excipients

Ammonio methacrylate copolymer type B
Calcium hydrogen phosphate dihydrate
Lactose monohydrate
Silica, colloidal anhydrous
Talc
Magnesium stearate

Pack sizes and marketing

The tablets are packed in PVC/PVDC opaque blister strips with aluminium foil backing. The pack consists of one blister strip containing 7, 20 or 21 tablets, or two blister strips containing 15 tablets each (30 tablets). The blisters are then packed in cardboard boxes.

Not all pack sizes may be marketed.

Marketing authorization holder

RAD Neurim Pharmaceuticals EEC SARL, 4 rue de Marivaux, 75002 Paris, France, e-mail: regulatory@neurim.com

Marketing authorization dates and numbers

EU/1/07/392/001
EU/1/07/392/002
EU/1/07/392/003
EU/1/07/392/004

Date of first authorisation: 29 June 2007
Date of latest renewal: 20 April 2012

Drugs

Drug Countries
CIRCADIN Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, South Africa

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