Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1299584
Name of medicinal product: CIRCADIN
Active substances:
Melatonin
Estonian, English, Latin
ATC code: N05CH01
Dosage form: prolonged-release tablet
Route of administration: oral use
Strengh: 2mg
Amount in package: 21TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: May 5, 2016
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada Väikseima müügiloleva ravimpakendi suuruses, kuid mitte üle 20 tableti
Entry/Changing date: February 7, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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