PHEBURANE

Medicinal product

(Invented) name

PHEBURANE

Active substance (s)

Natrio fenilbutiratas

Strength

350 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)

A16AX03, Sodium phenylbutyrate

Marketing authorisation holder

Eurocept International B. V., Nyderlandai

Date of authorisation

2013-07-31

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml geriamojo tirpalo yra:	1 ml
Natrio fenilbutiratas	350 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
112152	98267	1098267	buteliukas	100 ml, citrinų ir mėtų/juodųjų serbentų skonio užpilas (po 3 ml), dozavimo švirkštas ir buteliuko adapteris N1		Receptinis	EU/1/13/822/006	Netiekiama	-	-	No	-	-
116317	102419	1102419	buteliukas	100 ml, dozavimo švirkštas ir buteliuko adapteris N1		Receptinis	EU/1/13/822/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-31	Registruotas