Docetaxel Ebewe

Medicinal product

(Invented) name

Docetaxel Ebewe

Active substance (s)

Docetakselis

Strength

10 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)

L01CD02, Docetaxel

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2010-04-16

Date of renewal

2016-02-15

Documents

1953 Pakuotės lapelis 2023 11 09.docx

1953 Docetaxel Ebewe PCS PL 2023 11 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

AT/H/0254/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Docetakselis	10 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
31026	5518	1005518	flakonas	2 ml N1		Receptinis	LT/1/10/1953/001	Netiekiama	2025-07-08	2025-12-31	No	-	-	Download
31027	33477	1033477	flakonas	2 ml N5		Receptinis	LT/1/10/1953/002	Netiekiama	-	-	No	-	-
40545	54282	1054282	flakonas	2 ml N10		Receptinis	LT/1/10/1953/003	Netiekiama	-	-	No	-	-
40546	5596	1005596	flakonas	8 ml N1		Receptinis	LT/1/10/1953/004	Tiekiama	-	-	No	-	-
40547	54284	1054284	flakonas	8 ml N5		Receptinis	LT/1/10/1953/005	Netiekiama	-	-	No	-	-
40548	54285	1054285	flakonas	8 ml N10		Receptinis	LT/1/10/1953/006	Netiekiama	-	-	No	-	-
45728	59530	1059530	flakonas	16 ml N1		Receptinis	LT/1/10/1953/007	Netiekiama	-	-	No	-	-
45729	59531	1059531	flakonas	16 ml N5		Receptinis	LT/1/10/1953/008	Netiekiama	-	-	No	-	-
45730	59532	1059532	flakonas	16 ml N10		Receptinis	LT/1/10/1953/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-02-15	Perregistruotas
2010-04-16	Registruotas