Paclitaxel Accord

Medicinal product

(Invented) name

Paclitaxel Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2010-07-29

Date of renewal

2016-01-26

Documents

2115 Pakuotės lapelis 2025 02 05.docx

2115 Paclitaxel Accord II PL 2025 02 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1444/001/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
30456	32918	1032918	buteliukas	5 ml N1		Receptinis	LT/1/10/2115/001	Netiekiama	2025-07-11	2025-12-31	Yes	2025-07-18	2025-12-31
30457	32919	1032919	buteliukas	16,7 ml N1		Receptinis	LT/1/10/2115/002	Netiekiama	-	-	No	-	-
30458	32920	1032920	buteliukas	50 ml N1		Receptinis	LT/1/10/2115/003	Tiekiama	-	-	No	-	-
54513	68510	1068510	buteliukas	25 ml N1		Receptinis	LT/1/10/2115/004	Netiekiama	-	-	No	-	-
54514	68511	1068511	buteliukas	100 ml N1		Receptinis	LT/1/10/2115/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-26	Perregistruotas
2010-07-29	Registruotas