GuttaLax

Medicinal product

(Invented) name

GuttaLax

Active substance (s)

Natrio pikosulfatas

Strength

7,5 mg/ml

Pharmaceutical form

geriamieji lašai (tirpalas)

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A06AB08, Sodium picosulfate

Marketing authorisation holder

Opella Healthcare France SAS, Prancūzija

Date of authorisation

1996-03-29

Date of renewal

2007-10-30

Documents

0884 GuttaLax PCS 2025 05 29.docx

0884 Pakuotės lapelis 2024 12 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Natrio pikosulfatas	7,5 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
1495	7225	1007225	buteliukas	15 ml N1		Nereceptinis	LT/1/96/0884/001	Tiekiama	-	-	No	-	-	Download
9903	14510	1014510	buteliukas	30 ml N1		Nereceptinis	LT/1/96/0884/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-10-30	Perregistruotas
1996-03-29	Registruotas