Fluconazole ELVIM

Medicinal product

(Invented) name

Fluconazole ELVIM

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

SIA ELVIM, Latvija

Date of authorisation

2024-06-06

Date of renewal

Documents

5464_Fluconazole ELVIM.docx

5464_pakuotes lapelis_2024-06-06.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0388/001/DC

Marketing authorisation procedure

Decentralizuota 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
113860	99977	1099977	flakonas	100 ml N1		Receptinis	LT/1/24/5464/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-06	Registruotas