Duracef

Medicinal product

(Invented) name

Duracef

Active substance (s)

Cefadroksilis

Strength

250 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)

J01DB05, Cefadroxil

Marketing authorisation holder

Bausch Health Ireland Limited, Airija

Date of authorisation

1997-03-12

Date of renewal

2008-07-31

Documents

1240_4_5 Duracef milt ger susp PCS PL 210312.docx

1240_2_5 Pakuotės lapelis 210312.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

5 ml suspensijos yra	5 ml
Cefadroksilis	250 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
5999	2998	1002998	buteliukas	60 ml N1		Receptinis	LT/1/97/1240/004	Netiekiama	-	-	No	-	-
6542	2997	1002997	buteliukas	100 ml N1		Receptinis	LT/1/97/1240/005	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-07-31	Perregistruotas
1997-03-12	Registruotas