Amoksiklav

Medicinal product

(Invented) name

Amoksiklav

Active substance (s)

Amoksicilinas/Klavulano rūgštis

Strength

400 mg/57 mg/5 ml

Pharmaceutical form

milteliai geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01CR02, Amoxicillin and beta-lactamase inhibitor

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

1999-04-08

Date of renewal

2007-10-15

Documents

0825 Amoksiklav 400_57_5 milt ger susp PCS PL 2023 12 18t.docx

0825 Pakuotės lapelis 2023 12 18t.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

5 ml suspensijos yra	5 ml
Amoksicilinas	400 mg
Klavulano rūgštis	57 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
5439	4809	1004809	buteliukas	35 ml, N1		Receptinis	LT/1/99/0825/001	Netiekiama	-	-	No	-	-
5441	4810	1004810	buteliukas	70 ml, N1		Receptinis	LT/1/99/0825/002	Tiekiama	-	-	No	-	-	Download
107594	93699	1093699	buteliukas	140 ml N1		Receptinis	LT/1/99/0825/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-10-15	Perregistruotas
1999-04-08	Registruotas