Fluconazole ELVIM

Medicinal product

(Invented) name

Fluconazole ELVIM

Active substance (s)

Flukonazolas

Strength

150 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J02AC01, Fluconazole

Marketing authorisation holder

SIA ELVIM, Latvija

Date of authorisation

2009-12-23

Date of renewal

2013-10-31

Documents

1816 Fluconazole ELVIM PCS PL 2024 03 06.docx

1816 Pakuotės lapelis 2024 03 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1017/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Flukonazolas	150 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
33375	5531	1005531	lizdinė plokštelė	N1		Receptinis	LT/1/09/1816/009	Tiekiama	-	-	No	-	-	Download
38540	5575	1005575	lizdinė plokštelė	N2		Receptinis	LT/1/09/1816/010	Tiekiama	-	-	No	-	-
38541	5576	1005576	lizdinė plokštelė	N4		Receptinis	LT/1/09/1816/011	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-10-31	Perregistruotas
2009-12-23	Registruotas