Docetaxel Teva Pharma

Medicinal product

(Invented) name

Docetaxel Teva Pharma

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

Teva Pharma B.V., Nyderlandai

Date of authorisation

2014-06-13

Date of renewal

Documents

3577_1_4 Docetaxel Teva Pharma RPP 160916.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

UK/H/5460/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename vienadoziame flakone 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
56230	70326	1070326	flakonas	1 ml N1		Receptinis	LT/1/14/3577/001	Netiekiama	-	-	No	-	-
59337	73564	1073564	flakonas	4 ml N1		Receptinis	LT/1/14/3577/002	Netiekiama	-	-	No	-	-
59338	73565	1073565	flakonas	7 ml N1		Receptinis	LT/1/14/3577/003	Netiekiama	-	-	No	-	-
59339	73566	1073566	flakonas	8 ml N1		Receptinis	LT/1/14/3577/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-06	Išregistruotas
2014-06-13	Registruotas