Fosfomycin Zentiva

Medicinal product

(Invented) name

Fosfomycin Zentiva

Active substance (s)

Fosfomicinas

Strength

3 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

2021-08-27

Documents

3908_Fosfomycin Zentiva_perr2021-08-27.docx

3908_pakuotes lapelis_2021-08-27.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0130/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paketėlyje yra	1 vnt.
Fosfomicinas	3 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
61529	75869	1075869	paketėlis	N1		Receptinis	LT/1/16/3908/003	Tiekiama	-	-	No	-	-	Download
65614	80122	1080122	paketėlis	N2		Receptinis	LT/1/16/3908/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-27	Perregistruotas
2016-04-29	Registruotas