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PRODUCT DETAIL

AGOMED

Code 9800C
MA number 30/0375/18-S
Product Form: tbl flm 98x25 mg (blis.OPA/Al/PVC/Al-kalendár.bal.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: National
Therapeutic Class: 30 - ANTIDEPRESSIVA
ATC:
N NERVOUS SYSTEM
N06 PSYCHOANALEPTICS
N06A ANTIDEPRESSANTS
N06AX Other antidepressants
N06AX22 Agomelatine
Shelf life: 24
Container: blister OPA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 12.12.2018
Validity: 12.12.2023
Pediatric warnings: Yes
SPC: SPC_AGOMED_december_2018.docx  
PIL: PIL_AGOMED_05.2019.doc  
Safety feature Yes
Data update: 14.12.2018
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