Cefepime PharmSol

Medicinal product

(Invented) name

Cefepime PharmSol

Active substance (s)

Cefepimas

Strength

1 g

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DE01, Cefepime

Marketing authorisation holder

Pharmsol Europe Limited, Malta

Date of authorisation

2024-03-14

Date of renewal

Documents

5371 Cefepime PharmSol PCS PL 2025 05 10.docx

5371 Pakuotės lapelis 2025 05 10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

MT/H/0280/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Cefepimas	1 g

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
113091	99210	1099210	flakonas	N1		Receptinis	LT/1/24/5371/001	Netiekiama	-	-	No	-	-
113092	99211	1099211	flakonas	N50		Receptinis	LT/1/24/5371/002	Netiekiama	-	-	No	-	-
113093	99212	1099212	flakonas	N60		Receptinis	LT/1/24/5371/003	Netiekiama	-	-	No	-	-
113094	99213	1099213	flakonas	N5 (N1×5) (supakuota į kasetę)		Receptinis	LT/1/24/5371/004	Netiekiama	-	-	No	-	-
113095	99214	1099214	flakonas	N50 (N10×5) (supakuota į kasetę)		Receptinis	LT/1/24/5371/005	Netiekiama	-	-	No	-	-
113096	99215	1099215	flakonas	N60 (N12×5) (supakuota į kasetę)		Receptinis	LT/1/24/5371/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-14	Registruotas