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
Circadin 2 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. White to off-white, round, biconvex tablets. |
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 |
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.
RAD Neurim Pharmaceuticals EEC SARL, 4 rue de Marivaux, 75002 Paris, France, e-mail: regulatory@neurim.com
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
| Drug | Countries | |
|---|---|---|
| CIRCADIN | Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, South Africa |
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