Ertapenem QILU

Medicinal product

(Invented) name

Ertapenem QILU

Active substance (s)

Ertapenemas

Strength

1 g

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DH03, Ertapenem

Marketing authorisation holder

QILU PHARMA SPAIN S.L., Ispanija

Date of authorisation

2024-03-25

Date of renewal

Documents

5381 Pakuotės lapelis 2024 07 25.docx

5381 Ertapenem QILU RPP 2024 07 25.docx

PAR_Ertapenem_Qilu_SD+Summ+LT apzvalga.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0197/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Ertapenemas	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
113202	99321	1099321	flakonas	N1		Receptinis	LT/1/24/5381/001	Netiekiama	-	-	No	-	-
113203	99322	1099322	flakonas	N10		Receptinis	LT/1/24/5381/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-25	Registruotas