Docetaxel Mylan [Docetakselis Strides]

Medicinal product

(Invented) name

Docetaxel Mylan [Docetakselis Strides]

Active substance (s)

Docetakselis

Strength

40 mg/ml

Pharmaceutical form

koncentratas ir tirpiklis 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

Mylan S.A.S., Prancūzija

Date of authorisation

2012-07-19

Date of renewal

Documents

3017_1_2 Docetaxel Mylan konc RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename vienadoziame flakone yra	1 ml
Docetakselis	40 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
40128	53865	1053865	buteliukas	0,5 ml ir buteliukas tirpiklio (1,8 ml) N1		Receptinis	LT/1/12/3017/001	Netiekiama	-	-	No	-	-
40129	53866	1053866	buteliukas	2 ml ir buteliukas tirpiklio (7,1 ml) N1		Receptinis	LT/1/12/3017/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-04	Išregistruotas
2012-07-19	Registruotas