Imipenem/Cilastatin SUN

Medicinal product

(Invented) name

Imipenem/Cilastatin SUN

Active substance (s)

Imipenemas/Cilastatinas

Strength

500 mg/500 mg

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DH51, Imipenem and cilastatin

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2009-10-20

Date of renewal

2021-04-07

Documents

1742 Pakuotės lapelis 2022 03 14.docx

1742 Imipenem_Cilastatin SUN PCS PL 2022 03 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0163/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone/buteliuke yra:	1 vnt.
Imipenemas	500 mg
Cilastatinas	500 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
24720	27363	1027363	flakonas	22 ml ir perkėlimo rinkinys N1		Receptinis	LT/1/09/1742/001	Netiekiama	-	-	No	-	-
27623	30175	1030175	buteliukas	100 ml N1		Receptinis	LT/1/09/1742/002	Netiekiama	-	-	No	-	-
37361	51000	1051000	buteliukas	100 ml N10		Receptinis	LT/1/09/1742/003	Netiekiama	-	-	No	-	-
47121	60934	1060934	flakonas	30 ml N1		Receptinis	LT/1/09/1742/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-04-07	Perregistruotas
2009-10-20	Registruotas