Galieve

Medicinal product

(Invented) name

Galieve

Active substance (s)

Natrio alginatas/Natrio-vandenilio karbonatas/Kalcio karbonatas

Strength

500 mg/213 mg/325 mg/10 ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BX13, Alginic acid

Marketing authorisation holder

Reckitt Benckiser (Poland) S.A., Lenkija

Date of authorisation

2024-10-09

Date of renewal

Documents

5612 Galieve PCS PL 2024 11 27.docx

5612 Pakuotės lapelis 2024 11 27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

NL/H/5583/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Dozėje (10 ml suspensijos) yra:	10 ml
Natrio alginatas	500 mg
Natrio-vandenilio karbonatas	213 mg
Kalcio karbonatas	325 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
115348	101455	1101455	buteliukas	150 ml N1		Nereceptinis	LT/1/24/5612/001	Netiekiama	-	-	No	-	-
115349	101456	1101456	buteliukas	200 ml N1		Nereceptinis	LT/1/24/5612/002	Netiekiama	-	-	No	-	-
115350	101457	1101457	buteliukas	250 ml N1		Nereceptinis	LT/1/24/5612/003	Netiekiama	-	-	No	-	-
115351	101458	1101458	buteliukas	300 ml N1		Nereceptinis	LT/1/24/5612/004	Netiekiama	-	-	No	-	-
115352	101459	1101459	buteliukas	500 ml N1		Nereceptinis	LT/1/24/5612/005	Netiekiama	-	-	No	-	-
115353	101460	1101460	buteliukas	600 ml N1		Nereceptinis	LT/1/24/5612/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-09	Registruotas