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PRODUCT DETAIL

Spravato 28 mg nosová roztoková aerodisperzia

Code 7437E
MA number EU/1/19/1410/006
Product Form: aer nao 12(4x3)x28 mg (liek.skl.-multibal.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Janssen - Cilag International N.V., Belgium
Therapeutic Class: 30 - ANTIDEPRESSIVA
ATC:
N NERVOUS SYSTEM
N06 PSYCHOANALEPTICS
N06A ANTIDEPRESSANTS
N06AX Other antidepressants
N06AX27 Esketamine
Shelf life: 48
Container: glass container
Route of admin.: Nasal use
Prescription Status: Medicinal product subject to special medical prescription with skew blue stripe.
Legal basis: Article 8(3) application - known active substance
MA issued: 18.12.2019
SmPC + PL: European Medicines Agency's database
Dokument: Spravato_Príručka pre pacienta.pdf  
Dokument: Spravato_Kontrolný zoznam pre lekárov.pdf  
Dokument: Spravato_Príručka pre zdravotníckych pracovníkov.pdf  
Safety feature Yes
Data update: 11.09.2024
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