Ertapenem SUN

Medicinal product

(Invented) name

Ertapenem SUN

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)

ATC code (s)

J01DH03, Ertapenem

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2022-07-15

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for concentrate for solution for infusion	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
109019	95125	1095125	flakonas	N1		Receptinis	EU/1/22/1656/001	Netiekiama	-	-	No	-	-
109020	95126	1095126	flakonas	N10		Receptinis	EU/1/22/1656/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-15	Registruotas