Gentamicin Krka

Medicinal product

(Invented) name

Gentamicin Krka

Active substance (s)

Gentamicinas

Strength

40 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01GB03, Gentamicin

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

1994-06-22

Date of renewal

2009-10-14

Documents

1723 Gentamicin Krka 40mg_ml RPP 2024 12 06.docx

1723 Pakuotės lapelis 40mg_ml 2024 12 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Gentamicinas	40 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
5226	823	1000823	ampulė	1 ml N10		Receptinis	LT/1/94/1723/001	Netiekiama	-	2025-12-31	No	-	-

Stadijos

Data	Stadija
2009-10-14	Perregistruotas
1994-06-22	Registruotas