Refoxim

Medicinal product

(Invented) name

Refoxim

Active substance (s)

Cefuroksimas

Strength

750 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

3948 Refoxim RPP 2024 05 21.docx

3948 Pakuotės lapelis 2024 05 21.docx

Refoxim_750-1500_AR.pdf

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	750 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
64139	78586	1078586	flakonas	N1		Receptinis	LT/1/16/3948/001	Netiekiama	-	-	No	-	-
66106	80628	1080628	flakonas	N5		Receptinis	LT/1/16/3948/002	Netiekiama	-	-	No	-	-
66107	80629	1080629	flakonas	N55		Receptinis	LT/1/16/3948/003	Netiekiama	-	-	No	-	-

Stadijos

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