Amoxicillin/Clavulanic acid TZF

Medicinal product

(Invented) name

Active substance (s)

Amoksicilinas/Klavulano rūgštis

Strength

600 mg/42,9 mg/ml

Pharmaceutical form

milteliai geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J01CR02, Amoxicillin and beta-lactamase inhibitor

Marketing authorisation holder

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna, Lenkija

Date of authorisation

2025-12-11

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0987/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

5 ml paruoštos suspensijos yra:	5 ml
Amoksicilinas	600 mg
Klavulano rūgštis	42,9 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
119371	105476	1105476	buteliukas	50 ml (12,09 g miltelių) ir geriamasis švirkštas, N1		Receptinis	LT/1/25/5924/001	Netiekiama	-	-	No	-	-
119372	105477	1105477	buteliukas	100 ml (24,18 g miltelių) ir geriamasis švirkštas, N1		Receptinis	LT/1/25/5924/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-12-11	Registruotas