Gentamicin PPH [GENTAMICIN WZF Polfa]

Medicinal product

(Invented) name

Gentamicin PPH [GENTAMICIN WZF Polfa]

Active substance (s)

Gentamicinas

Strength

3 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01AA11, Gentamicin

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

1994-07-05

Date of renewal

2010-02-04

Documents

1854 Pakuotės lapelis 2025 06 06.docx

1854 Gentamicin PPH RPP 2025 06 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	3 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
2541	3954	1003954	buteliukas	5 ml N1		Receptinis	LT/1/94/1854/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-02-04	Perregistruotas
1994-07-05	Registruotas