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PRODUCT DETAIL

ZTALMY 50 mg/ml perorálna suspenzia

Code 4196E
MA number EU/1/23/1743/002
Product Form: sus por 5x110ml/5 500 mg (fľ.HDPE+5 dávk.striek.+ 5 adaptérov)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Marinus Pharmaceuticals Emerald Limited, Ireland
Therapeutic Class: 21 - ANTIEPILEPTICA, ANTICONVULSIVA
ATC:
N NERVOUS SYSTEM
N03 ANTIEPILEPTICS
N03A ANTIEPILEPTICS
N03AX Other antiepileptics
N03AX27 Ganaxolone
Shelf life: 24
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 26.07.2023
Validity: 26.07.2028
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 21.09.2023
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