Refoxim

Medicinal product

(Invented) name

Refoxim

Active substance (s)

Cefuroksimas

Strength

1500 mg

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DC02, Cefuroxime

Marketing authorisation holder

UAB Eletis Pharma, Lietuva

Date of authorisation

2016-08-02

Date of renewal

2021-05-18

Documents

Refoxim_750-1500_AR.pdf

3948 Refoxim RPP 2024 05 21.docx

3948 Pakuotės lapelis 2024 05 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Cefuroksimas	1500 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
64140	78587	1078587	flakonas	N1		Receptinis	LT/1/16/3948/004	Tiekiama	-	-	No	-	-	Download
66108	80630	1080630	flakonas	N5		Receptinis	LT/1/16/3948/005	Netiekiama	-	-	No	-	-
66109	80631	1080631	flakonas	N55		Receptinis	LT/1/16/3948/006	Netiekiama	-	-	No	-	-
67557	82111	1082111	flakonas	N60		Receptinis	LT/1/16/3948/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-18	Perregistruotas
2016-08-02	Registruotas