Tolnexa

Medicinal product

(Invented) name

Tolnexa

Active substance (s)

Docetakselis

Strength

20 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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2013-04-26

Date of renewal

2018-04-12

Documents

3278_1_3 Pakuotės lapelis 210304.docx

3278_1_3 Tolnexa konc inf PCS PL 210304.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2591/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 koncentrato mililitre yra	1 ml
Docetakselis	20 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
51254	65147	1065147	flakonas	1 ml N1		Receptinis	LT/1/13/3278/001	Netiekiama	-	-	No	-	-	Download
56102	70164	1070164	flakonas	4 ml N1		Receptinis	LT/1/13/3278/002	Netiekiama	-	-	No	-	-
56103	70165	1070165	flakonas	8 ml N1		Receptinis	LT/1/13/3278/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-27	Išregistruotas
2018-04-12	Perregistruotas
2013-04-26	Registruotas