ZTALMY

Medicinal product

(Invented) name

ZTALMY

Active substance (s)

Ganaksolonas

Strength

50 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N03AX27, ganaxolone

Marketing authorisation holder

Immedica Pharma AB, Švedija

Date of authorisation

2023-07-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral suspension	1 ml
Ganaksolonas	50 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
111423	97536	1097536	buteliukas	110 ml N1 (2 dozavimo švirkštai (3 ml) + 2 dozavimo švirkštai (12 ml) + buteliuko adapteris)		Receptinis	EU/1/23/1743/001	Netiekiama	-	-	No	-	-
111424	97537	1097537	buteliukas	110 ml N5 (2 dozavimo švirkštai (3 ml) + 2 dozavimo švirkštai (12 ml) + buteliuko adapteris)		Receptinis	EU/1/23/1743/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-26	Registruotas