Livmarli

Medicinal product

(Invented) name

Livmarli

Active substance (s)

Maraliksibato chloridas

Strength

9,5 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A05AX04, maralixibat chloride

Marketing authorisation holder

Mirum Pharmaceuticals International B.V., Nyderlandai

Date of authorisation

2022-12-09

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 solution	1 ml
Maraliksibato chloridas	9,5 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
109957	96065	1096065	buteliukas	30 ml N1 (trys geriamieji švirkštai (0,5 ml, 1 ml, 3 ml))		Receptinis	EU/1/22/1704/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-09	Registruotas