Ximaract

Medicinal product

(Invented) name

Ximaract

Active substance (s)

Cefuroksimas

Strength

50 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į akies kamerą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01AA27, Cefuroxime

Marketing authorisation holder

BAUSCH + LOMB IRELAND LIMITED, Airija

Date of authorisation

2016-09-26

Date of renewal

2021-07-09

Documents

3976 Ximaract RPP 2021 12 07.docx

3976 Pakuotės lapelis 2021 12 07.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/1494/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename flakone yra	1 vnt.
Cefuroksimas	50 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
61771	76127	1076127	flakonas	N1		Receptinis	LT/1/16/3976/001	Netiekiama	-	-	No	-	-
66664	81200	1081200	flakonas	N10		Receptinis	LT/1/16/3976/002	Netiekiama	-	-	No	-	-
66665	81201	1081201	flakonas	N25		Receptinis	LT/1/16/3976/003	Netiekiama	-	-	No	-	-
107537	93642	1093642	flakonas	ir sterili filtravimo adata, N1		Receptinis	LT/1/16/3976/004	Netiekiama	-	-	No	-	-
107538	93643	1093643	flakonas	ir sterili filtravimo adata, N10		Receptinis	LT/1/16/3976/005	Netiekiama	-	-	No	-	-
107539	93644	1093644	flakonas	ir sterili filtravimo adata, N25		Receptinis	LT/1/16/3976/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-30	Išregistruotas
2021-07-09	Perregistruotas
2016-09-26	Registruotas