Paclitaxel EBEWE

Medicinal product

(Invented) name

Paclitaxel EBEWE

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

Sandoz d.d., Slovėnija

Date of authorisation

2007-01-30

Date of renewal

2010-12-15

Documents

0645 Pakuotės lapelis 2023 05 30.docx

0645 Paclitaxel EBEWE konc inf PCS PL 2023 05 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0146/001

Marketing authorisation procedure

Savitarpio pripažinimo 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
19413	4699	1004699	flakonas	5 ml N1		Receptinis	LT/1/06/0645/001	Tiekiama	-	-	No	-	-	Download
21560	4700	1004700	flakonas	16,7 ml N1		Receptinis	LT/1/06/0645/002	Netiekiama	-	-	No	-	-
21561	4701	1004701	flakonas	25 ml N1		Receptinis	LT/1/06/0645/003	Netiekiama	-	-	No	-	-
21562	4702	1004702	flakonas	50 ml N1		Receptinis	LT/1/06/0645/004	Tiekiama	-	-	No	-	-	Download
32281	34673	1034673	flakonas	5 ml N5		Receptinis	LT/1/06/0645/005	Netiekiama	-	-	No	-	-
32282	34674	1034674	flakonas	5 ml N10		Receptinis	LT/1/06/0645/006	Netiekiama	-	-	No	-	-
51704	65600	1065600	flakonas	100 ml N1		Receptinis	LT/1/06/0645/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-12-15	Perregistruotas
2007-01-30	Registruotas