Paclitaxel Kabi

Medicinal product

(Invented) name

Paclitaxel Kabi

Active substance (s)

Paklitakselis

Strength

6 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)

L01CD01, Paclitaxel

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2009-06-10

Date of renewal

2018-04-12

Documents

1602 Paclitaxel Kabi PCS PL 2022 08 31.docx

1602 Pakuotės lapelis 2022 08 31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0879/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Paklitakselis	6 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
27394	5483	1005483	flakonas	5 ml N1		Receptinis	LT/1/09/1602/001	Tiekiama	-	-	No	-	-	Download
27395	29950	1029950	flakonas	5 ml N5		Receptinis	LT/1/09/1602/002	Netiekiama	-	-	No	-	-
27396	5484	1005484	flakonas	16,7 ml N1		Receptinis	LT/1/09/1602/003	Netiekiama	-	-	No	-	-
35860	38192	1038192	flakonas	16,7 ml N5		Receptinis	LT/1/09/1602/004	Netiekiama	-	-	No	-	-
35861	5556	1005556	flakonas	50 ml N1		Receptinis	LT/1/09/1602/005	Tiekiama	-	-	No	-	-	Download
35862	38194	1038194	flakonas	50 ml N5		Receptinis	LT/1/09/1602/006	Netiekiama	-	-	No	-	-
44276	58069	1058069	flakonas	25 ml, N1		Receptinis	LT/1/09/1602/007	Netiekiama	-	-	No	-	-
44277	58070	1058070	flakonas	25 ml, N5		Receptinis	LT/1/09/1602/008	Netiekiama	-	-	No	-	-
44278	58071	1058071	flakonas	100 ml, N1		Receptinis	LT/1/09/1602/009	Netiekiama	-	-	No	-	-
44279	58072	1058072	flakonas	100 ml, N5		Receptinis	LT/1/09/1602/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-12	Perregistruotas
2009-06-10	Registruotas