PHELINUN

Medicinal product

(Invented) name

PHELINUN

Active substance (s)

Melfalanas

Strength

50 mg

Pharmaceutical form

milteliai ir tirpiklis infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AA03, Melphalan

Marketing authorisation holder

Adienne S.r.l. S.U., Italija

Date of authorisation

2020-11-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for concentrate for solution for infusion	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
105378	91478	1091478	flakonas	milteliai ir flakonas tirpiklio (10 ml) N1		Receptinis	EU/1/20/1487/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-16	Registruotas