Ravicti

Medicinal product

(Invented) name

Ravicti

Active substance (s)

Glicerolio fenilbutiratas

Strength

1,1 g/ml

Pharmaceutical form

geriamasis skystis

Route (s) of administration

vartoti per burną, vartoti į virškinimo traktą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX09, Glycerol phenylbutyrate

Marketing authorisation holder

Immedica Pharma AB, Švedija

Date of authorisation

2015-11-27

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 liquid	1 ml
Glicerolio fenilbutiratas	1,1 g

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
64639	79123	1079123	buteliukas	25 ml N1		Receptinis	EU/1/15/1062/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-27	Registruotas