Lactulose-ratiopharm

Medicinal product

(Invented) name

Lactulose-ratiopharm

Active substance (s)

Laktuliozė

Strength

667 mg/ml

Pharmaceutical form

geriamasis tirpalas

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

ratiopharm GmbH, Vokietija

Date of authorisation

2009-09-25

Date of renewal

2012-06-04

Documents

1700_1_3 Lactulose_ratioph geriam RPP 160819.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0728/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Laktuliozė	667 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
33927	36288	1036288	buteliukas	300 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1700/001	Netiekiama	-	-	No	-	-	Download
36852	50464	1050464	buteliukas	500 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1700/002	Netiekiama	-	-	No	-	-
36853	50465	1050465	buteliukas	1000 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1700/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-02	Išregistruotas
2012-06-04	Perregistruotas
2009-09-25	Registruotas