Fluconazole Baxter

Medicinal product

(Invented) name

Fluconazole Baxter

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

Baxter Holding B.V. , Nyderlandai

Date of authorisation

2008-02-22

Date of renewal

2017-01-03

Documents

1001 Fluconazole Baxter PCS PL 2024 03 21.docx

1001 Pakuotės lapelis 2024 03 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0862/001

Marketing authorisation procedure

Savitarpio pripažinimo 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
21924	24761	1024761	flakonas	100 ml N1		Receptinis	LT/1/08/1001/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2017-01-03	Perregistruotas
2008-02-22	Registruotas