This brand name is authorized in Austria, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, UK.
The drug CIRCADIN contains one active pharmaceutical ingredient (API):
1
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UNII
JL5DK93RCL - MELATONIN
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| CIRCADIN Prolonged-release tablet | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| N05CH01 | Melatonin | N Nervous system → N05 Psycholeptics → N05C Hypnotics and sedatives → N05CH Melatonin receptor agonists |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 574-MEE-1214 |
| EE | Ravimiamet | 1299584, 1362800, 1555893, 1665457 |
| ES | Centro de información online de medicamentos de la AEMPS | 07392003 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 396554 |
| FR | Base de données publique des médicaments | 68578854 |
| GB | Medicines & Healthcare Products Regulatory Agency | 161497, 175353, 185692, 196843, 376246, 381254 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6752 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1028231, 1063292, 1063293, 1071179 |
| NL | Z-Index G-Standaard, PRK | 86819 |
| NZ | Medicines and Medical Devices Safety Authority | 14294 |
| PL | Rejestru Produktów Leczniczych | 100192290 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W52114001, W52114002 |
| SG | Health Sciences Authority | 13954P |
| ZA | Health Products Regulatory Authority | 44/2.2/0001 |
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