Micafungin Accord

Medicinal product

(Invented) name

Micafungin Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2024-02-28

Date of renewal

Documents

5361 Pakuotės lapelis 2025 05 09.docx

5361 Micafungin Accord PCS PL 2025 05 09.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1169/002/DC

Marketing authorisation procedure

Decentralizuota 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
112990	99108	1099108	flakonas	N1		Receptinis	LT/1/24/5361/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-28	Registruotas