ZOLSKETIL pegylated liposomal

Medicinal product

(Invented) name

ZOLSKETIL pegylated liposomal

Active substance (s)

Doksorubicino hidrochloridas

Strength

2 mg/ml

Pharmaceutical form

koncentratas infuzinei dispersijai

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01DB01, Doxorubicin

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2022-05-31

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

Concentrate for dispersion for infusion	1 ml
Doksorubicino hidrochloridas	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
108842	94948	1094948	flakonas	10 ml N1		Receptinis	EU/1/22/1629/001	Tiekiama	-	-	No	-	-
108843	94949	1094949	flakonas	10 ml N10		Receptinis	EU/1/22/1629/002	Netiekiama	-	-	No	-	-
108844	94950	1094950	flakonas	25 ml N1		Receptinis	EU/1/22/1629/003	Netiekiama	-	-	No	-	-
108845	94951	1094951	flakonas	25 ml N10		Receptinis	EU/1/22/1629/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-31	Registruotas