Gastrobiol

Medicinal product

(Invented) name

Gastrobiol

Active substance (s)

Laktuliozė

Strength

650 mg/ml

Pharmaceutical form

valgomasis gelis

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A06AD11, Lactulose

Marketing authorisation holder

MIP Pharma GmbH, Vokietija

Date of authorisation

2012-10-30

Date of renewal

Documents

3113_01-03 Gastrobiol_DP.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml valgomojo gelio yra	1 ml
Laktuliozė	650 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
46512	60320	1060320	plačiakaklis indas	100 ml ir matavimo šaukštas (5 ml) N1		Nereceptinis	LT/1/12/3113/001	Netiekiama	-	-	No	-	-
54161	68150	1068150	plačiakaklis indas	200 ml ir matavimo šaukštas (5 ml) N1		Nereceptinis	LT/1/12/3113/002	Netiekiama	-	-	No	-	-
54162	68151	1068151	plačiakaklis indas	500 ml ir matavimo šaukštas (5 ml) N1		Nereceptinis	LT/1/12/3113/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-10-06	Išregistruotas
2012-10-30	Registruotas