Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CIRCADIN
Active substances:
Melatonin
Estonian, English, Latin
ATC code: N05CH01
Dosage form: prolonged-release tablet
Strength: 2mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Safety features: Yes
Marketing authorization holder: RAD Neurim Pharmaceuticals EEC SARL 
Marketing authorization number: EU/1/07/392 
Marketing authorization issued on: June 29, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada Väikseima müügiloleva ravimpakendi suuruses, kuid mitte üle 20 tableti
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1299584  CIRCADIN  prolonged-release tablet  2mg 21TK  Prescription      05.05.2016     
1362800  CIRCADIN  prolonged-release tablet  2mg 20TK  Prescription           
1555893  CIRCADIN  prolonged-release tablet  2mg 30TK  Prescription      20.05.2024     
1665457  CIRCADIN  prolonged-release tablet  2mg 7TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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