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PRODUCT DETAIL

Valdoxan 25 mg filmom obalené tablety

Code 66542
MA number EU/1/08/499/005
Product Form: tbl flm 56x25 mg (blis.Al/PVC)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 30 - ANTIDEPRESSIVA
ATC:
N NERVOUS SYSTEM
N06 PSYCHOANALEPTICS
N06A ANTIDEPRESSANTS
N06AX Other antidepressants
N06AX22 Agomelatine
Shelf life: 36
Container: blister Al/PVC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 19.02.2009
SmPC + PL: European Medicines Agency's database
Dokument: DHCP Valdoxan 14 10 2013.pdf  
Dokument: DHPC Valdoxan 10_10 2012.pdf  
Safety feature Yes
Data update: 21.12.2018
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