Fosfomycin Ladee Pharma

Medicinal product

(Invented) name

Fosfomycin Ladee Pharma

Active substance (s)

Fosfomicinas

Strength

3 g

Pharmaceutical form

granulės 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

UAB Exeltis Baltics , Lietuva

Date of authorisation

2013-05-30

Date of renewal

Documents

3309_1_2 Fosfomycin Ladee Pharma II PL 170705.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

UK/H/4403/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename vienadoziame 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
40161	53898	1053898	paketėlis	8 g N1		Receptinis	LT/1/13/3309/001	Netiekiama	-	-	No	-	-
56267	70363	1070363	paketėlis	8 g N2		Receptinis	LT/1/13/3309/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-10-05	Išregistruotas
2013-05-30	Registruotas