Helicobacter Test INFAI

Medicinal product

(Invented) name

Helicobacter Test INFAI

Active substance (s)

(13)C-karbamidas

Strength

45 mg

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Purpose for use

3-11 m. vaikams

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V04CX, Other diagnostic agents

Marketing authorisation holder

INFAI GmbH, Vokietija

Date of authorisation

2002-10-10

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

powder for oral solution	1 vnt.
(13)C-karbamidas	45 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
26132	28721	1028721	plačiakaklis indas	N1 (ąsotėlis, 4 bandinių buteliukai)		Receptinis	EU/1/97/045/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-10-10	Registruotas