Fluconazole IBE

Medicinal product

(Invented) name

Fluconazole IBE

Active substance (s)

Flukonazolas

Strength

2 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J02AC01, Fluconazole

Marketing authorisation holder

UAB Eletis Pharma, Lietuva

Date of authorisation

2017-04-06

Date of renewal

2022-07-18

Documents

4063 Pakuotės lapelis 2024 07 05.docx

4063 Fluconazole IBE RPP 2024 07 05.docx

Fluconazole_IBE_AR.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Flukonazolas	2 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
68076	82639	1082639	buteliukas	100 ml N1		Receptinis	LT/1/17/4063/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-07-18	Perregistruotas
2017-04-06	Registruotas