Duphalac Fruit

Medicinal product

(Invented) name

Duphalac Fruit

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

Cooper Consumer Health B.V., Nyderlandai

Date of authorisation

2009-10-20

Date of renewal

2015-05-26

Documents

1746 Duphalac Fruit PCS 2025 09 08.docx

1746 Pakuotės lapelis 2025 08 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

AT/H/0242/001/DC

Marketing authorisation procedure

Decentralizuota 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
30886	33341	1033341	paketėlis	15 ml N20		Nereceptinis	LT/1/09/1746/001	Tiekiama	-	-	No	-	-	Download
30426	32888	1032888	buteliukas	200 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1746/002	Netiekiama	-	-	No	-	-	Download
37310	50949	1050949	buteliukas	300 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1746/003	Netiekiama	-	-	No	-	-
37311	50950	1050950	buteliukas	500 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1746/004	Tiekiama	-	-	No	-	-
37312	50951	1050951	buteliukas	800 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1746/005	Netiekiama	-	-	No	-	-
37313	50952	1050952	buteliukas	1000 ml ir matavimo taurelė N1		Nereceptinis	LT/1/09/1746/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-05-26	Perregistruotas
2009-10-20	Registruotas