Paclitaxel Actavis

Medicinal product

(Invented) name

Paclitaxel Actavis

Active substance (s)

Paklitakselis

Strength

6 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)

L01CD01, Paclitaxel

Marketing authorisation holder

Actavis Group PTC ehf., Islandija

Date of authorisation

2008-03-06

Date of renewal

2013-10-31

Documents

1039_1_4 Paclitaxel Actavis konc inf PZ PL 180502.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1782/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Paklitakselis	6 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
21214	4950	1004950	flakonas	5 ml (30 mg/5 ml) N1		Receptinis	LT/1/08/1039/001	Netiekiama	-	-	No	-	-	Download
29193	5095	1005095	flakonas	16,7 ml (100 mg/16,7 ml) N1		Receptinis	LT/1/08/1039/002	Netiekiama	-	-	No	-	-
29194	31697	1031697	flakonas	25 ml (150 mg/25 ml) N1		Receptinis	LT/1/08/1039/003	Netiekiama	-	-	No	-	-
29195	31698	1031698	flakonas	50 ml (300 mg/50 ml) N1		Receptinis	LT/1/08/1039/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-05	Išregistruotas
2013-10-31	Perregistruotas
2008-03-06	Registruotas