Paclimedac

Medicinal product

(Invented) name

Paclimedac

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

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2008-02-08

Date of renewal

2011-07-20

Documents

1005_1_8 Paclimedac konc inf PCS PL 200323.docx

1005_1_8 Pakuotės lapelis 200323.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/1159/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo 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
22387	5061	1005061	flakonas	5 ml N1		Receptinis	LT/1/08/1005/001	Netiekiama	-	-	No	-	-
28531	31053	1031053	flakonas	16,7 ml N1		Receptinis	LT/1/08/1005/002	Netiekiama	-	-	No	-	-
28532	5062	1005062	flakonas	50 ml N1		Receptinis	LT/1/08/1005/003	Netiekiama	-	-	No	-	-	Download
47979	61801	1061801	flakonas	5 ml N10		Receptinis	LT/1/08/1005/004	Netiekiama	-	-	No	-	-
47980	61802	1061802	flakonas	16,7 ml N10		Receptinis	LT/1/08/1005/005	Netiekiama	-	-	No	-	-
47981	61803	1061803	flakonas	50 ml N10		Receptinis	LT/1/08/1005/006	Netiekiama	-	-	No	-	-
60511	74790	1074790	flakonas	100 ml N1		Receptinis	LT/1/08/1005/007	Netiekiama	-	-	No	-	-
60512	74791	1074791	flakonas	100 ml N10		Receptinis	LT/1/08/1005/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-30	Išregistruotas
2011-07-20	Perregistruotas
2008-02-08	Registruotas