Caelyx pegylated liposomal [Caelyx]

Medicinal product

(Invented) name

Caelyx pegylated liposomal [Caelyx]

Active substance (s)

Doksorubicino hidrochloridas

Strength

2 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

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

Baxter Holding B.V. , Nyderlandai

Date of authorisation

1996-06-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution 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
11059	15575	1015575	flakonas	10 ml N1		Receptinis	EU/1/96/011/001	Tiekiama	-	-	No	-	-
11060	15576	1015576	flakonas	10 ml N10		Receptinis	EU/1/96/011/002	Netiekiama	-	-	No	-	-
25453	28060	1028060	flakonas	25 ml N1		Receptinis	EU/1/96/011/003	Netiekiama	-	-	No	-	-
25454	28061	1028061	flakonas	25 ml N10		Receptinis	EU/1/96/011/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1996-06-21	Registruotas