Stinem

Medicinal product

(Invented) name

Stinem

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

Medochemie Ltd., Kipras

Date of authorisation

2025-09-19

Date of renewal

Documents

5849_pakuotes lapelis_2025-09-19.docx

5849_Stinem.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2944/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone 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
118681	104785	1104785	flakonas	N1		Receptinis	LT/1/25/5849/001	Netiekiama	-	-	No	-	-
118682	104786	1104786	flakonas	N10		Receptinis	LT/1/25/5849/002	Netiekiama	-	-	No	-	-
118683	104787	1104787	flakonas	N25		Receptinis	LT/1/25/5849/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-09-19	Registruotas