Ammonaps

Medicinal product

(Invented) name

Ammonaps

Active substance (s)

Natrio fenilbutiratas

Strength

940 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

Immedica Pharma AB, Švedija

Date of authorisation

1999-12-08

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

granules	1 g
Natrio fenilbutiratas	940 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
24729	27372	1027372	buteliukas	266 g ir 3 dozavimo šaukštai N1		Receptinis	EU/1/99/120/003	Netiekiama	-	-	No	-	-
24730	27373	1027373	buteliukas	532 g ir 3 dozavimo šaukštai N1		Receptinis	EU/1/99/120/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1999-12-08	Registruotas