PHEBURANE

Medicinal product

(Invented) name

PHEBURANE

Active substance (s)

Natrio fenilbutiratas

Strength

483 mg/g

Pharmaceutical form

granulės

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

Granules	1 g
Natrio fenilbutiratas	483 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
56971	71078	1071078	buteliukas	174 g N1 (+graduotas matavimo šaukštas)		Receptinis	EU/1/13/822/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-31	Registruotas