Docetaxel Hospira

Medicinal product

(Invented) name

Docetaxel Hospira

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

Hospira UK Limited, Jungtinė Karalystė

Date of authorisation

2009-11-25

Date of renewal

2018-06-25

Documents

1784_1_3 Pakuotės lapelis 181130.docx

1784_1_3 Docetaxel Hospira II PL 181130.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

ES/H/0666/001

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
23365	26072	1026072	flakonas	2 ml N1		Receptinis	LT/1/09/1784/001	Netiekiama	-	-	No	-	-
23366	26073	1026073	flakonas	8 ml N1		Receptinis	LT/1/09/1784/002	Netiekiama	-	-	No	-	-
23367	26074	1026074	flakonas	16 ml N1		Receptinis	LT/1/09/1784/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-06	Išregistruotas
2018-06-25	Perregistruotas
2009-11-25	Registruotas