Gentamicin Sopharma

Medicinal product

(Invented) name

Gentamicin Sopharma

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

SOPHARMA AD, Bulgarija

Date of authorisation

2002-02-06

Date of renewal

2010-05-12

Documents

1994_1-4_Gentamicin_Sopharma_inj_inf_tirp_RPP_181109.docx

Stage

Išregistruotas

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
41010	54747	1054747	ampulė	1 ml N10		Receptinis	LT/1/02/1994/001	Netiekiama	-	-	No	-	-	Download
41011	54748	1054748	ampulė	1 ml N100		Receptinis	LT/1/02/1994/002	Netiekiama	-	-	No	-	-
3108	4555	1004555	ampulė	2 ml N10		Receptinis	LT/1/02/1994/003	Netiekiama	-	-	No	-	-
41012	54749	1054749	ampulė	2 ml N100		Receptinis	LT/1/02/1994/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-08-31	Išregistruotas
2010-05-12	Perregistruotas
2002-02-06	Registruotas