Foziflum [Fosfomycin Sandoz]

Medicinal product

(Invented) name

Foziflum [Fosfomycin Sandoz]

Active substance (s)

Fosfomicinas

Strength

3 g

Pharmaceutical form

milteliai geriamajam tirpalui

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

Sandoz d.d., Slovėnija

Date of authorisation

2019-02-08

Date of renewal

2023-09-19

Documents

4330 Pakuotės lapelis 2023 11 21.docx

4330 Foziflum RPP 2023 11 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4186/001/DC

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
100930	87041	1087041	paketėlis	N1		Receptinis	LT/1/19/4330/001	Netiekiama	2025-07-17	2025-09-16	No	-	-	Download
100931	87042	1087042	paketėlis	N2		Receptinis	LT/1/19/4330/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-19	Perregistruotas
2019-02-08	Registruotas