Micafungin Pharmazac

Medicinal product

(Invented) name

Micafungin Pharmazac

Active substance (s)

Mikafunginas

Strength

100 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J02AX05, Micafungin

Marketing authorisation holder

Pharmazac S.A, Graikija

Date of authorisation

2024-10-16

Date of renewal

Documents

5620_pakuotes lapelis_2024-10-16.docx

5620_Micafungin Pharmazac.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/6116/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Mikafunginas	100 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
115548	101655	1101655	flakonas	N1		Receptinis	LT/1/24/5620/001	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-16	Registruotas