Melphalan Zentiva

Medicinal product

(Invented) name

Melphalan Zentiva

Active substance (s)

Melfalanas

Strength

50 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną, leisti į arteriją

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AA03, Melphalan

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2019-05-17

Date of renewal

2024-02-14

Documents

4389 Melphalan Zentiva II PL 2025 01 22.docx

4389 Pakuotės lapelis 2025 01 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1796/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Melfalanas	50 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
101644	87748	1087748	flakonas	milteliai ir tirpiklio flakonas (10 ml) N1		Receptinis	LT/1/19/4389/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-14	Perregistruotas
2019-05-17	Registruotas