Betaklav

Medicinal product

(Invented) name

Betaklav

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2015-08-06

Date of renewal

2021-02-10

Documents

3778 Betaklav milt ger susp PCS PL 2024 06 21.docx

3778 Pakuotės lapelis 2024 06 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0503/003/DC

Marketing authorisation procedure

Decentralizuota 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
58208	72334	1072334	buteliukas	30 ml ir geriamasis švirkštas N1		Receptinis	LT/1/15/3778/001	Netiekiama	-	-	No	-	-
63337	77775	1077775	buteliukas	60 ml ir geriamasis švirkštas N1		Receptinis	LT/1/15/3778/002	Netiekiama	-	-	No	-	-
63338	77776	1077776	buteliukas	70 ml ir geriamasis švirkštas N1		Receptinis	LT/1/15/3778/003	Tiekiama	-	-	No	-	-	Download
63339	77777	1077777	buteliukas	100 ml ir geriamasis švirkštas N1		Receptinis	LT/1/15/3778/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-10	Perregistruotas
2015-08-06	Registruotas