Cefepime MIP

Medicinal product

(Invented) name

Cefepime MIP

Active substance (s)

Cefepimas

Strength

2 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

MIP Pharma GmbH, Vokietija

Date of authorisation

2014-12-23

Date of renewal

2019-07-12

Documents

3666_1-6 Cefepime_perr2019-07-12.docx

3666_01-06 pakuotes lapelis_2019-07-12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2986/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename flakone yra	1 vnt.
Cefepimas	2 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
56236	70332	1070332	flakonas	N1		Receptinis	LT/1/14/3666/004	Netiekiama	-	-	No	-	-
61007	75317	1075317	flakonas	N5		Receptinis	LT/1/14/3666/005	Netiekiama	-	-	No	-	-
61008	75318	1075318	flakonas	N10		Receptinis	LT/1/14/3666/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-12	Perregistruotas
2014-12-23	Registruotas