Amoxicillin/Clavulanic acid Antibiotice

Medicinal product

(Invented) name

Amoxicillin/Clavulanic acid Antibiotice

Active substance (s)

Amoksicilinas/Klavulano rūgštis

Strength

1000 mg/200 mg

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01CR02, Amoxicillin and beta-lactamase inhibitor

Marketing authorisation holder

Antibiotice S.A, Rumunija

Date of authorisation

2026-07-24

Date of renewal

Documents

6098_pakuotes lapelis_2026-07-24.docx

6098_Amox_Clav_Antibiotice.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0926/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Amoksicilinas	1000 mg
Klavulano rūgštis	200 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
121703	107812	1107812	flakonas	N1		Receptinis	LT/1/26/6098/001	Netiekiama	-	-	No	-	-
121704	107813	1107813	flakonas	N10		Receptinis	LT/1/26/6098/002	Netiekiama	-	-	No	-	-
121705	107814	1107814	flakonas	N25		Receptinis	LT/1/26/6098/003	Netiekiama	-	-	No	-	-
121706	107815	1107815	flakonas	N50		Receptinis	LT/1/26/6098/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-07-24	Registruotas