MEDOCLAV

Medicinal product

(Invented) name

MEDOCLAV

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

Medochemie Ltd., Kipras

Date of authorisation

2017-04-06

Date of renewal

2022-01-10

Documents

Kalixinate_LT_116_DC_ PAR_summary+scient disc+LT apzvalga_170406.pdf

4064 MEDOKLAV 400_57_5 milt ger susp RPP 2023 03 30.docx

4064 Pakuotės lapelis milt 2023 03 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0116/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

5 ml paruoštos 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
64059	78506	1078506	buteliukas	70 ml ir geriamasis švirkštas N1		Receptinis	LT/1/17/4064/001	Netiekiama	-	-	No	-	-
68077	82640	1082640	buteliukas	140 ml ir geriamasis švirkštas N1		Receptinis	LT/1/17/4064/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-10	Perregistruotas
2017-04-06	Registruotas