Fosfomycin Zentiva

Medicinal product

(Invented) name

Fosfomycin Zentiva

Active substance (s)

Fosfomicinas

Strength

2 g

Pharmaceutical form

granulės geriamajam tirpalui paketėlyje

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01XX01, Fosfomycin

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2016-04-29

Date of renewal

Documents

3908_1_2 Fosfomycin Zentiva 2g II PL 190111.docx

3908_1_2 Pakuotės lapelis 190111.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0130/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paketėlyje yra	1 vnt.
Fosfomicinas	2 g

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
61528	75868	1075868	paketėlis	N1		Receptinis	LT/1/16/3908/001	Netiekiama	-	-	No	-	-
65613	80121	1080121	paketėlis	N2		Receptinis	LT/1/16/3908/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-06-29	Išregistruotas
2016-04-29	Registruotas